MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2012

NORTHERN TERRITORY OF AUSTRALIA MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2012 As in force at 10 February 2026 Table of provisions Chapter 1 Introduction Part 1.1 Preliminary matters 1 Short title ......................................................................................... 1 2 Commencement .............................................................................. 1 3 Objects ............................................................................................ 1 4 Overview.......................................................................................... 2 Part 1.2 Interpretation Division 1 Defined terms 5 Definitions ........................................................................................ 3 Division 2 Important concepts Subdivision 1 Substances to which this Act applies 7 Meaning of Scheduled substance and related terms ..................... 12 8 Meaning of unrestricted Schedule 4 substance and restricted Schedule 4 substance ................................................................... 13 9 Meaning of pesticide ...................................................................... 13 10 Meaning of unrestricted Schedule 8 substance and restricted Schedule 8 substance ................................................................... 13 12 Meaning of prohibited substance ................................................... 13 Subdivision 2 Medicines and poisons standard 14 Meaning of medicines and poisons standard................................. 13 15 Interpretation provisions in medicines and poisons standard – application to Act ........................................................................... 14 16 When medicines and poisons standard applies to substances...... 15 Subdivision 3 Dealing with Scheduled substances 17 Meaning of deal with ...................................................................... 15 18 Meaning of manufacture ................................................................ 16 19 Meaning of prescription ................................................................. 16 20 Meaning of possess ....................................................................... 16 21 Meaning of supply and sell ............................................................ 16 -- 1 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 ii 22 Meaning of use and administer...................................................... 17 Subdivision 4 Health practitioners and others authorised to deal with Scheduled substances 23 Meaning of health practitioner and related terms........................... 17 24 Meaning of doctor and NT doctor .................................................. 18 25 Meaning of nurse, midwife and related terms ................................ 18 26 Meaning of dentist and dental therapist ......................................... 18 27 Meaning of optometrist, pharmacist and podiatrist ........................ 19 28 Meaning of Aboriginal and Torres Strait Islander health practitioner ..................................................................................... 19 28A Meaning of paramedic ................................................................... 19 Part 1.3 Application of Act 29 Act binds Crown ............................................................................ 20 30 Inconsistency between Act and medicines and poisons standard......................................................................................... 20 31 Relationship with Health Practitioner Regulation National Law ..... 20 31A Relationship with Hemp Industry Act 2019 .................................... 20 32 Relationship with Misuse of Drugs Act 1990.................................. 21 33 Application of Criminal Code ......................................................... 21 Chapter 2 Dealing with Scheduled substances Part 2.1 Requirements for registration and licensing of manufacturers, wholesalers and retailers 34 Manufacturer of certain Scheduled substances to be registered....................................................................................... 22 35 Wholesaler of certain Scheduled substances to be registered ...... 23 36 Retailer of Schedule 2 and 7 substances to be licensed ............... 23 Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 1 Schedule 3 substances 37 Supply of Schedule 3 substance ................................................... 23 38 Administration of Schedule 3 substance ........................................ 24 Division 2 Schedule 4 substances 39 Possession .................................................................................... 24 40 Supply ........................................................................................... 25 41 Use ................................................................................................ 25 -- 2 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 iii Division 3 Pesticides and other Schedule 7 substances 42 Supply by authorised persons only ................................................ 25 43 Supply to authorised persons only................................................. 26 44 Use ................................................................................................ 27 Division 4 Schedule 8 substances Subdivision 1 Unrestricted Schedule 8 substances 45 Possession .................................................................................... 28 46 Supply generally ............................................................................ 28 47 Use generally................................................................................. 28 48 Supplying and administering in prohibited circumstances ............. 29 Subdivision 2 Restricted Schedule 8 substances 49 Possession .................................................................................... 29 50 Supply ........................................................................................... 30 51 Use ................................................................................................ 30 Division 5 Prohibited substances 52 Possession .................................................................................... 31 53 Supply ........................................................................................... 31 54 Use ................................................................................................ 32 Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 1 Authorised health practitioners 55 Schedule 4 substances and unrestricted Schedule 8 substances .................................................................................... 33 Subdivision 2 Pharmacists 56 Possessing Schedule 4 and 8 substances .................................... 33 57 Supplying Schedule 4 and 8 substances – general ....................... 33 58 Supplying Schedule 4 and 8 substances – prescription of interstate prescribers ..................................................................... 35 59 Supplying unrestricted Schedule 4 substance in emergency for patient previously supplied on prescription ............................... 35 59A Supplying unrestricted Schedule 4 substance – continued dispensing ..................................................................................... 36 -- 3 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 iv 60 Supplying unrestricted Schedule 4 substance for patient in residential care .............................................................................. 36 61 Supplying Schedule 4 and 8 substances on oral request of authorised prescriber ..................................................................... 37 Subdivision 3 Other health practitioners 63 Administering Schedule 4 or 8 substances under administration order – Aboriginal and Torres Strait health practitioners, nurses, midwives and pharmacists .......................... 38 64 Administering Schedule 4 or 8 substances supplied on supply order – nurses employed at residential facilities ............................ 38 66 Dentists.......................................................................................... 39 68 Optometrists .................................................................................. 39 69 Podiatrists ...................................................................................... 39 Subdivision 3A Administering, supplying and possessing Scheduled substances under SSTP 70 Definitions ...................................................................................... 39 70A Prescribed health practitioners and healthcare workers ................ 40 70B Form and content of SSTP ............................................................ 40 70C Administering, supplying and possessing Schedule 4 or 8 substance under SSTP – prescribed health practitioners .............. 41 70D Administering, supplying and possessing Schedule 3, 4 or 8 substance under SSTP – prescribed healthcare workers .............. 42 Subdivision 4 Special provisions for health practitioners to supply and administer Schedule 3 substances 71 Supplying Schedule 3 substances ................................................. 43 72 Administering Schedule 3 substances ........................................... 43 Subdivision 5 Additional qualifications for health practitioners under Health Practitioner Regulation National Law 73 Endorsement on health practitioner's registration for additional qualifications .................................................................................. 43 Division 2 Other authorisations 74 Veterinarians ................................................................................. 44 75 Supplying and administering Schedule 3 substance supplied by health practitioner ..................................................................... 44 76 Possessing and administering lawfully supplied Schedule 4 and 8 substances for administering to patients.............................. 44 77 Possessing and administering lawfully supplied Schedule 4 and 8 substances for administering to animals .............................. 45 -- 4 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 v 78 Possessing, supplying and administering Schedule 3, 4 and 8 substances under emergency authorisation .................................. 46 79 Possessing Scheduled substances for delivery ............................. 46 80 Possessing Scheduled substances for destruction........................ 47 Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 1 Authorised prescribers Subdivision 1 Schedule 4 substances 81 Unrestricted Schedule 4 substance ............................................... 47 82 Restricted Schedule 4 substance .................................................. 48 Subdivision 2 Schedule 8 substances 83 Unrestricted Schedule 8 substance – general ............................... 48 84 Unrestricted Schedule 8 substance – prohibited circumstances.... 49 85 Restricted Schedule 8 substance .................................................. 49 Subdivision 3 Additional qualifications for health practitioners under Health Practitioner Regulation National Law 86 Endorsement on health practitioner's registration for additional qualifications .................................................................................. 50 Division 2 Issue of prescriptions 87 Requirements for prescription........................................................ 51 88 Duration of prescription ................................................................. 51 89 Issuing prescription to patient ........................................................ 51 90 No self-prescription of Schedule 8 or restricted Schedule 4 substances .................................................................................... 52 91 Quantity of Schedule 8 substance authorised by prescription ....... 53 Division 3 Orders for administering and supplying Schedule 4 and 8 substances 92 Authorised prescriber may authorise administration and supply by order ......................................................................................... 53 Part 2.5 Special provisions about supplies of Schedule 4 and 8 substances 93 Supply of Schedule 4 and 8 substances on prescription ............... 54 94 Repeat supply of Schedule 8 substance ....................................... 54 -- 5 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 vi 95 Health practitioner to ensure self-administration of some supplied Schedule 8 substances ................................................... 55 96 Pharmacist to give CHO prescription for supply of Schedule 8 substance ...................................................................................... 55 97 Obligations of authorised prescriber and pharmacist for supply made without prescription in emergency ....................................... 56 Part 2.6 Special provisions about dealing with Scheduled substances in hospitals, residential facilities and declared places 98 Storage at hospital......................................................................... 56 99 Administering Schedule 3, 4 or 8 substance at hospital, residential facility or declared place ............................................... 57 100 Administration or supply of Schedule 8 substance to be witnessed....................................................................................... 58 Part 2.7 Other requirements for Scheduled substances Division 1 Packaging and labelling 101 Packaging supplied Scheduled substances .................................. 60 102 Labelling supplied Scheduled substances ..................................... 60 103 Permanently marked containers – use for other Scheduled substances .................................................................................... 60 104 Scheduled substance container not to be used for human-use substance ...................................................................................... 61 Division 2 Vending machine supplies 105 Definitions ...................................................................................... 62 106 Vending machine supplies of unscheduled substances ................ 62 Division 3 Methylated spirit 107 Drinking methylated spirit .............................................................. 63 108 Supplying methylated spirit for drinking ......................................... 63 Division 4 Paints 110 Manufacture, supply and use of first, second and third schedule paints.............................................................................. 63 111 Manufacture, supply and use of paints for toys ............................. 64 112 Manufacture, supply and use of paints containing pesticides ........ 65 Division 4A Advertising use of pesticides 112A Definition........................................................................................ 65 -- 6 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 vii 112B Representation by unauthorised person ........................................ 65 112C Advertisement to include authorisation number ............................. 65 Division 5 Miscellaneous matters 113 Advertising some Scheduled substances ...................................... 66 114 No self-administration of Schedule 8 or restricted Schedule 4 substances .................................................................................... 67 Part 2.8 CHO prohibitions 115 Temporary prohibition on dealing with substance.......................... 68 116 Prohibition on health practitioner or veterinarian dealing with Schedule 8 substance ................................................................... 69 Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 1 Interpretation 117 Types of authorities ....................................................................... 71 118 Suitability of authority holder – individuals ..................................... 71 119 Suitability of authority holder – bodies corporate ........................... 72 120 Suitability of nominated person – certificate of registration ............ 73 Division 2 Authorised activities under authorities 121 Manufacturer certificate of registration .......................................... 73 122 Wholesaler certificate of registration.............................................. 74 122A Schedule 4 supplier certificate of registration ................................ 74 123 Retailer licence .............................................................................. 74 123A Schedule 3 authorisation ............................................................... 75 124 Schedule 4 authorisation ............................................................... 75 125 Schedule 7 authorisation ............................................................... 75 126 Pest management technician licence ............................................ 75 127 Schedule 8 authorisation ............................................................... 76 128 Prohibited substance authorisation................................................ 76 129 Research authorisation .................................................................. 77 130 Medical kit authorisation ................................................................ 77 Part 3.2 Application process for authorities Division 1 Making and consideration of application 131 Making application ......................................................................... 78 132 CHO may require further information ............................................. 78 -- 7 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 viii 133 CHO to give application for Schedule 8 authorisation to Committee ..................................................................................... 79 134 Considering and deciding application ............................................ 79 Division 2 Restrictions on issue of authorities 135 Certificate of registration ................................................................ 80 136 Retailer licence .............................................................................. 80 136A Schedule 3 authorisation ............................................................... 81 137 Schedule 4 authorisation ............................................................... 81 138 Pest management technician licence ............................................ 81 139 Schedule 8 authorisation ............................................................... 81 140 Prohibited substance authorisation................................................ 82 141 Research authorisation .................................................................. 84 142 Medical kit authorisation ................................................................ 85 Division 3 Conditions of authorities 143 Conditions – general...................................................................... 85 144 Conditions – certificate of registration............................................ 86 145 Conditions – retailer licence........................................................... 86 145A Conditions – Schedule 3 authorisation .......................................... 86 146 Conditions – Schedule 8 authorisation .......................................... 87 147 Contravention of condition ............................................................. 87 Division 4 Miscellaneous matters 148 Duration of authority ...................................................................... 87 149 Form of authority ........................................................................... 87 150 Notice of refusal to issue authority or impose conditions ............... 87 151 Failure to decide application .......................................................... 87 Part 3.3 Renewal of licences and certificates of registration 152 Application for renewal .................................................................. 88 153 Authority continues until application decided ................................. 88 Part 3.4 Transfer of authorities 154 Transfer of certificate of registration .............................................. 88 155 Other authorities not transferable .................................................. 88 Part 3.5 Variation of conditions of authorities Division 1 Interpretation 156 Definitions ...................................................................................... 88 -- 8 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 ix Division 2 Variation of conditions of authority on CHO's initiative 157 CHO may vary conditions to achieve object of Act ........................ 89 Division 3 Variation of conditions of authority on application by holder 158 Application ..................................................................................... 90 159 CHO may require further information ............................................. 90 160 Considering and deciding application ............................................ 90 161 Notice of decision on application ................................................... 90 162 Failure to decide application .......................................................... 90 Division 4 Miscellaneous matters 163 Application of Division ................................................................... 91 164 When variation of conditions takes effect ...................................... 91 165 Recording variation of conditions................................................... 91 Part 3.6 Suspension and cancellation of authorities 166 Grounds for suspending or cancelling authority............................. 92 167 Show cause notice ........................................................................ 92 168 Ending show cause process without further action ........................ 93 169 Suspension or cancellation ............................................................ 93 170 Return of cancelled authority to CHO ............................................ 94 171 Immediate suspension of authority pending formal cancellation procedure ...................................................................................... 94 Part 3.7 Miscellaneous matters 172 Medical examination for some authorities ..................................... 95 173 Authority holder to give notice of change of particulars ................. 96 174 Replacement of authority ............................................................... 97 175 Surrender of authority .................................................................... 97 176 Display of certificate of registration ................................................ 97 177 Authority not personal property...................................................... 98 Chapter 4 Enforcement Part 4.1 Interpretation 178 Definitions ...................................................................................... 99 179 When thing is connected with offence ........................................... 99 -- 9 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 x Part 4.2 Powers of authorised officers to enter places 180 Entry of place – general ................................................................. 99 181 Consent to entry .......................................................................... 100 182 Entry of place – search warrant ................................................... 100 183 Entry to Aboriginal land ............................................................... 101 184 Additional powers for entry of aircraft, vehicle or vessel .............. 101 Part 4.3 Powers of authorised officers on entry of places 185 Powers on entry of place ............................................................. 102 186 Restriction on power of seizure ................................................... 103 187 Authorised officer may use help and force in exercising powers ......................................................................................... 104 Part 4.4 Seized and forfeited things Division 1 Notice, retention and return of seized thing 188 Application of Division ................................................................. 104 189 Notice of seizure of thing ............................................................. 104 190 Retention of thing seized ............................................................. 104 191 Return of seized thing .................................................................. 105 Division 2 Order disallowing seizure of seized thing 192 Application for order disallowing seizure ..................................... 105 193 CHO is respondent to application ................................................ 105 194 Order disallowing seizure ............................................................ 106 195 Ancillary orders ............................................................................ 106 196 Adjournment pending hearing of other proceeding ...................... 106 Division 3 Forfeiture of seized thing 197 When seized thing is forfeited...................................................... 107 198 Destruction or disposal of forfeited thing ..................................... 107 199 Return of forfeited thing ............................................................... 107 200 Compensation to be paid in certain circumstances ..................... 108 Part 4.5 General powers of CHO and authorised officers 201 Compliance notice ....................................................................... 108 202 Contravention of compliance notice............................................. 109 203 Power to prohibit supply of incorrectly packed or labelled substance .................................................................................... 109 204 Power to require name and address............................................ 110 -- 10 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 xi 205 Power to require information from persons .................................. 110 206 Requirement to give documents or information ........................... 111 Part 4.6 Other offences 207 Offence to disclose certain information ........................................ 111 208 Misleading information ................................................................. 113 209 Obstruction of authorised officer or assistant............................... 114 210 Falsely representing to be authorised officer ............................... 114 211 Bribery of authorised officer ......................................................... 114 Part 4.7 Legal proceedings and evidentiary matters Division 1 Criminal liability for offences 212 Definitions .................................................................................... 115 213 Liability of representative ............................................................. 115 214 Conduct of representative............................................................ 115 215 Criminal liability of executive officer of body corporate ................ 117 Division 2 Miscellaneous matters 216 Self-incrimination ......................................................................... 118 217 Judicial notice .............................................................................. 118 218 Time for starting offence proceeding ........................................... 119 219 Evidentiary certificate .................................................................. 119 Chapter 5 Reconsideration and review of decisions 220 Meaning of original decision and affected person........................ 120 221 Request for reconsideration of original decision .......................... 120 222 Operation and implementation of original decision ...................... 120 223 Reconsideration of decision......................................................... 120 224 Application for review of reconsidered decision ........................... 121 225 Operation and implementation of reconsidered decision ............. 121 226 Review procedure........................................................................ 121 227 Decision on review ...................................................................... 122 Chapter 6 Therapeutic Goods Act applies as a law of the Territory Part 6.1 Interpretation 228 Definitions .................................................................................... 123 229 Words have meanings in Therapeutic Goods Act........................ 123 Part 6.2 Applied provisions 230 Application of Therapeutic Goods Act as law of Territory ............ 124 -- 11 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 xii 231 Modification of Therapeutic Goods Act ........................................ 124 232 Interpretation of applied provisions .............................................. 124 Part 6.3 Functions and powers under applied provisions 233 Functions and powers of Commonwealth Minister and officials .. 124 234 Delegations by Commonwealth Minister and Secretary .............. 125 235 Appointments under Therapeutic Goods Act ............................... 125 Part 6.4 Administrative law 236 Application of Commonwealth administrative laws to applied provisions .................................................................................... 125 237 Functions and powers conferred on Commonwealth officers and authorities ............................................................................. 126 Part 6.5 Offences under applied provisions 238 Object of Part............................................................................... 126 239 Application of Commonwealth criminal laws to offences against applied provisions ........................................................... 127 240 Functions and powers conferred on Commonwealth officials relating to offences ...................................................................... 127 241 No double jeopardy for offences against applied provisions ........ 127 Part 6.6 Miscellaneous matters 242 Reference in Commonwealth law to provision of another law ..... 128 243 Fees and other money................................................................. 128 Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 1 Interpretation 243A Definitions .................................................................................... 129 243B Meaning of recordable prescription and recordable supply ......... 129 Division 2 Establishment and maintenance of monitored medicines database 243C Monitored medicines database to be kept ................................... 130 243D Powers and functions of CHO in relation to database ................. 131 243E Persons required to give information to CHO .............................. 132 -- 12 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 xiii Division 3 Access to monitored medicines database 243F Access for relevant prescribers and pharmacists ........................ 133 243G Access for other persons ............................................................. 134 Division 4 Offences 243H Person must not contravene requirement to give information...... 135 243J Relevant prescriber must check database before prescribing monitored medicine ..................................................................... 135 243K Pharmacist must check database before supplying monitored medicine ...................................................................................... 136 243L Unauthorised access, use or disclosure of information ............... 136 Division 5 Administrative matters 243M Protection from liability for duties and functions in relation to database ...................................................................................... 137 243N Data source entity........................................................................ 138 243P Sharing agreement ...................................................................... 138 243Q Guidelines.................................................................................... 138 Part 7.1 Codes of practice 244 CHO may make code of practice ................................................. 138 Part 7.2 CHO's powers and responsibilities Division 1 Exemptions, declarations and approvals for dealing with Scheduled substances 245 Exemption from holding Schedule 8 authorisation....................... 139 246 Restricted Schedule 4 and 8 substances .................................... 140 251 Emergency authorisation for possessing, supplying and administering Schedule 3, 4 and 8 substances ........................... 140 252 Declared places ........................................................................... 141 253 Approval for pharmacist to supply Schedule 8 substance or restricted Schedule 4 substances on interstate prescription ........ 141 254 Approval of SSTP ........................................................................ 142 Division 2 Register of authorities and information availability 255 Register of authorities.................................................................. 142 256 Public access to some registers .................................................. 143 Division 3 Other administrative powers 257 Information relating to supply and use of substances .................. 143 -- 13 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 xiv 258 Approved forms ........................................................................... 143 259 Delegation by CHO ...................................................................... 143 Part 7.3 Scheduled Substances Clinical Advisory Committee Division 1 Establishment, functions and powers 260 Establishment .............................................................................. 144 261 Functions ..................................................................................... 144 262 Powers......................................................................................... 145 263 Delegation ................................................................................... 145 Division 2 Provisions about membership 264 Membership ................................................................................. 145 265 Qualifications and nominations for appointment .......................... 145 266 Duration of appointment .............................................................. 145 267 Conditions of appointment ........................................................... 146 268 Chairperson and deputy chairperson ........................................... 146 269 When member ceases to hold office ........................................... 146 Division 3 Conduct of business 270 Meetings ...................................................................................... 147 271 Presiding member at meetings .................................................... 147 272 Procedure at meetings ................................................................ 147 273 Disclosure of interest ................................................................... 147 Part 7.4 Authorised officers 274 Who is authorised officer ............................................................. 148 275 Identity cards ............................................................................... 148 276 Production of identity card ........................................................... 149 277 Return of identity card ................................................................. 149 Chapter 8 Miscellaneous matters 278 Acquisition on just terms .............................................................. 150 279 Protection of health practitioners and veterinarians from liability .......................................................................................... 150 280 Protection of persons administering Act from liability .................. 150 281 Regulations.................................................................................. 151 Chapter 9 Repeals and transitional matters Part 9.1 Repeal of Acts 282 Repeals ....................................................................................... 152 -- 14 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 xv Part 9.2 Transitional matters for Medicines, Poisons and Therapeutic Goods Act 2012 283 Definitions .................................................................................... 152 284 Prescriptions and directions for dealing with Scheduled substances .................................................................................. 153 285 Old authority ................................................................................ 154 286 Pending application relating to authority ...................................... 154 287 Pending action to vary, suspend or revoke authorisation ............ 155 288 Suspended authorisation ............................................................. 155 289 Provisions relating to employment involving pesticides ............... 155 290 Directions under section 30 of repealed Act ................................ 156 291 Prohibitions under sections 31 and 31N of repealed Act ............. 156 292 Registers of manufacturer and wholesaler premises ................... 157 293 Interpretation Act not affected...................................................... 157 Part 9.3 Transitional matters for Statute Law Amendment (Directors' Liability) Act 2015 295 Offences – before and after commencement............................... 157 Part 9.4 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2021 296 Definitions .................................................................................... 158 297 Information obtained before commencement .............................. 158 298 Offences – before and after commencement............................... 158 Part 9.5 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 299 Definitions .................................................................................... 159 300 Scheduled substance treatment protocols approved before commencement ........................................................................... 159 301 Transitional authority for health practitioners approved to administer Schedule 4 or 8 substance before commencement ... 159 302 Transitional authority for health practitioners approved to supply Schedule 4 or 8 substance before commencement ......... 160 303 COVID-19 vaccine administration protocols approved before commencement ........................................................................... 161 304 Transitional authority for persons authorised to deal with COVID-19 vaccine before commencement ................................. 161 305 Supply of Schedule 3 substances – authorities issued before commencement ........................................................................... 161 306 Declared places ........................................................................... 162 307 Offence provisions – before and after commencement ............... 162 -- 15 of 187 -- Medicines, Poisons and Therapeutic Goods Act 2012 xvi Schedule 1 Declared provisions Schedule 2 Original decisions and affected persons Schedule 3 Repealed Acts ENDNOTES -- 16 of 187 -- NORTHERN TERRITORY OF AUSTRALIA ____________________ As in force at 10 February 2026 ____________________ MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2012 An Act about medicines, poisons and therapeutic goods Chapter 1 Introduction Part 1.1 Preliminary matters 1 Short title This Act may be cited as the Medicines, Poisons and Therapeutic Goods Act 2012. 2 Commencement This Act commences on the day fixed by the Administrator by Gazette notice. 3 Objects (1) The main object of this Act is to promote and protect public health and safety by minimising: (a) accidental and deliberate poisoning by Scheduled substances; and (b) misadventures by poisoning by Scheduled substances; and (c) the manufacture of substances that are subject to abuse (substances of abuse); and (d) the diversion for abuse of substances of abuse; and (e) harm from therapeutic goods. (2) Other objects of this Act are to ensure: (a) consumers of Schedule 4 and 8 substances have adequate information and the understanding necessary to allow them to administer the substances safely and effectively; and -- 17 of 187 -- Chapter 1 Introduction Part 1.1 Preliminary matters Medicines, Poisons and Therapeutic Goods Act 2012 2 (b) consumers of Schedule 2 and 3 substances have adequate information and the understanding to allow them to: (i) select the most appropriate substances for their condition; and (ii) administer the substances safely and effectively, taking into account the condition of their health. 4 Overview (1) The objects of this Act are primarily achieved by prohibiting and regulating people dealing with Scheduled substances. (2) In general, under Part 2.1, only the holder of an authority issued under Chapter 3 may manufacture and, in some circumstances sell, Scheduled substances. (3) In addition, under Part 2.2, only those authority holders, or health practitioners, veterinarians and others authorised under Part 2.3, may possess, supply or use Scheduled substances. (4) Those general rules are subject to, or complemented by, special rules under Parts 2.4 to 2.8 about the following: (a) the issue of prescriptions for the supply of Scheduled substances by health practitioners and veterinarians; (b) the storage, packaging, labelling, advertisement, supply by vending machines, transport and destruction of Scheduled substances; and (c) the manufacture, supply and use of paints containing Scheduled substances; and (d) other circumstances in which dealing with Scheduled substances may be prohibited. (5) Apart from prohibiting and regulating people dealing with Scheduled substances, Chapter 6 contributes to achieving the objects of this Act by adopting in the Territory a uniform Australian approach to the regulation of therapeutic goods. (6) For the effective administration and enforcement of this Act, provision is made about the following: (a) codes of practice and exemptions; (b) the Scheduled Substances Clinical Advisory Committee; -- 18 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 3 (c) authorised officers and their functions and powers. Part 1.2 Interpretation Division 1 Defined terms 5 Definitions In this Act: Aboriginal and Torres Strait Islander health practitioner, see section 28(1). accepted representations, for Part 3.6, see section 167(4). acting in an official capacity, in relation to an authorised officer, means the officer is exercising powers or performing functions under, or otherwise related to the administration of, this Act. addiction, to a Scheduled substance, means a state of physiological or psychological dependence on, or increased tolerance to, the habitual and excessive use of the substance, and includes pain and other symptomatic indications arising specifically from withdrawal of the substance. administer, see section 22(2). administration order, see section 92(1)(a). affected person, see section 220(2). applied provisions, for Chapter 6, see section 228. appointed members, see section 264(1)(a). approved form means a form approved under section 258. approved SSTP, for Chapter 2, Part 2.3, Division 1, Subdivision 3A, see section 70. at, for Chapter 4, see section 178. authorised officer, see section 274(1). authorised health practitioner, see section 23(2). authorised prescriber, for a Scheduled substance, means a health practitioner or veterinarian who is authorised under Part 2.4, Division 1, to issue a prescription for the supply of the substance. -- 19 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 4 authorised purpose means: (a) for the use of a Schedule 4 or unrestricted Schedule 8 substance: (i) analysing or testing specimens for the diagnosis of a disease of humans, animals or plants; or (ia) treatment and prevention of a disease of humans, animals or plants; or (ii) providing a higher education course; or (iii) forensic science; or (iv) preservation of animal or plant specimens; or (v) domestic animal control; or (vi) sedation of wild animals; or (vii) mineral testing; or (viii) another purpose prescribed by regulation; or (c) for the use of a restricted Schedule 8 substance: (i) therapeutic use; or (ii) treating an addiction to a substance; or (iii) analysing or testing specimens for the diagnosis of a disease of humans or animals; or (iiia) treatment and prevention of a disease of humans or animals; or (iv) providing a higher education course; or (v) forensic science. authority, see section 117. certificate of registration means: (a) a manufacturer certificate of registration; or (b) a wholesaler certificate of registration; or (c) a Schedule 4 supplier certificate of registration. -- 20 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 5 CHO means the Chief Health Officer. code of practice means a code of practice in force under section 244. Committee means the Scheduled Substances Clinical Advisory Committee established by section 260. Commonwealth administrative laws, for Chapter 6, see section 228. Commonwealth Minister, for Chapter 6, see section 228. Commonwealth official, for Chapter 6, see section 228. Commonwealth Secretary, for Chapter 6, see section 228. compliance notice, see section 201(1). condition, for Part 3.5, see section 156. connected, for Chapter 4, see section 179. corresponding law: (a) for section 207 – means a law of a State or another Territory that: (i) corresponds, or substantially corresponds, to this Act; and (ii) is declared by regulation to be a corresponding law; or (b) for Chapter 7, Part 7.1AA – see section 243A. data source entity, see section 243A. deal with, for a Scheduled substance, see section 17. declared place means a health centre or clinic declared under section 252 to be a place to which Part 2.6 applies. declared provision, for Part 4.7, Division 1, see section 212. dental hygienist, see section 26(3). dental therapist, see section 26(2). dentist, see section 26(1). doctor, see section 24(1). -- 21 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 6 endorsed midwife, see section 25(6). enter, for Chapter 4, see section 178. executive officer, of a body corporate, means a director or other person who is concerned with, or takes part in, the management of the body corporate. forfeited thing, for Part 4.4, see section 198(1). health practitioner, see section 23(1). health profession, see section 5 of the Health Practitioner Regulation National Law. hospital means: (a) a hospital as defined in section 5 of the Medical Services Act 1982; or (b) a private hospital as defined in section 4 of the Private Hospitals Act 1981. information notice, for a decision, means a written notice stating the following: (a) the decision and the reasons for it; (b) that a reconsideration of the decision may be sought; (c) the period allowed for requesting the reconsideration; (d) how to request the reconsideration. interstate prescriber, for a Schedule 4 or 8 substance, means a health practitioner in a State or another Territory who is authorised under the law of that State or Territory to issue a prescription for the supply of the substance. licence means: (a) a retailer licence; or (b) a pest management technician licence. licensed place means a place for which a retailer licence is in force. -- 22 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 7 manager, for: (a) a hospital declared under section 6(2) of the Medical Services Act 1982 – means the person appointed under section 7(2)(a) of that Act to be the person in charge of the hospital; or (b) a private hospital licensed under the Private Hospitals Act 1981 – see section 4 of that Act. manufacture, see section 18. manufacturer certificate of registration, see section 121. manufacturer's pack, for Part 2.7, Division 2, see section 105. medical kit authorisation, see section 130. medical or scientific research includes for analysis, clinical trials, instruction and study. medicines and poisons standard, see section 14(1). methylated spirit means: (a) a spirit that has been methylated or denatured; or (b) methyl alcohol or wood spirit; or (c) a spirit to which a methylated substance has been added; or (d) a drinkable liquid with which a methylated spirit is mixed. midwife, see section 25(5). minimum repeat interval, for a repeat prescription for the supply of a Scheduled substance, means the period stated in the prescription that limits the frequency of the repeat supplies of the substance. Note Under the Australian Government's Pharmaceutical Benefits Scheme, an authorised prescriber is required to state the minimum repeat interval for some Scheduled substances. modifications, for Chapter 6, see section 228. monitored medicine, see section 243A. monitored medicines database, see section 243C(1). nominated person, see section 131(c). -- 23 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 8 NT doctor, see section 24(2). NT health practitioner, see section 23(3). NT nurse practitioner, see section 25(3). NT specialist health practitioner, see section 23(4). nurse, see section 25(1). nurse practitioner, see section 25(2). occupier, of a place: (a) generally, means: (i) a person in occupation of the place; or (ii) the person in control of the place; or (iii) if the place has different parts occupied or controlled by different persons – each person in occupation or control of the part concerned; or (b) for Chapter 4 – see section 178. optometrist, see section 27(1). oral health therapist, see section 26(4). original decision, see section 220(1). paramedic, see section 28A(1). patient, of a hospital, includes a person attending the hospital for treatment as an outpatient by a health practitioner. pesticide, see section 9. pest authorisation, for Chapter 2, Part 2.7, Division 4A, see section 112A. pest management technician licence, see section 126. pharmacist, see section 27(2). pharmacy, see clause 1 of Schedule 7 to the Health Practitioners Act 2004. podiatrist, see section 27(3). -- 24 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 9 place includes: (a) vacant land; and (b) premises; and (c) an aircraft, vehicle or vessel. possess, see section 20. premises includes: (a) a building or structure; and (b) a part of a building or structure; and (c) land on which a building or structure is situated. prescribed health practitioner, for Chapter 2, Part 2.3, Division 1, Subdivision 3A, see section 70. prescribed healthcare worker, for Chapter 2, Part 2.3, Division 1, Subdivision 3A, see section 70. prescription, see section 19. prohibited circumstance, see: (a) for the supply or administration of an unrestricted Schedule 8 substance – section 48(2); or (b) for issuing a prescription for the supply of an unrestricted Schedule 8 substance – section 84(2). prohibited substance, see section 12. prohibited substance authorisation, see section 128. proposed action, for Part 3.6, see section 167(2)(a). reconsidered decision, see section 223(1)(b). recordable prescription, see section 243B(1) and (2). recordable supply, see section 243B(3) and (4). registered place means a place for which a certificate of registration is in force. relevant prescriber, see section 243A. -- 25 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 10 repeat prescription means a prescription authorising the supply of a Scheduled substance on more than one occasion. representative, for Part 4.7, Division 1, see section 212. research authorisation, see section 129. residential facility means a residential facility for which an approval is in force under the Aged Care Act 1997 (Cth) for an approved provider to provide residential care to persons in the facility. restricted Schedule 4 substance, see section 8(2). restricted Schedule 8 substance, see section 10(2). retailer licence, see section 123. review notice, see section 223(1)(b). Schedule 3 authorisation, see section 123A. Schedule 4 authorisation, see section 124. Schedule 4 substance declaration means a declaration in force under section 246 for a restricted Schedule 4 substance. Schedule 4 supplier certificate of registration, see section 122A. Schedule 7 authorisation, see section 125(1). Schedule 8 authorisation, see section 127. Schedule 8 exemption means an exemption in force under section 245(1). Scheduled substance, see section 7. Scheduled substance treatment protocol, see section 70B(1). seized thing, for Part 4.4, see section 188. sell, see section 21(3). SSTP means a Scheduled substance treatment protocol. suitable person, for Chapter 3, means: (a) for the holder of an authority – an individual or body corporate that is a suitable person to hold the authority under section 118 or 119; or -- 26 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 1 Defined terms Medicines, Poisons and Therapeutic Goods Act 2012 11 (b) for a nominated person for a certificate of registration – an individual who is a suitable person for the authority under section 120. supply, see section 21(1) and (2). supply order, see section 92(1)(b). therapeutic goods, see section 3(1) of the Therapeutic Goods Act. Therapeutic Goods Act means the Therapeutic Goods Act 1989 (Cth). Note Under sections 15(2), 51 and 52 of the Interpretation Act 1978, a reference to a Commonwealth Act includes a reference to: (a) the Act as amended and in force from time to time; and (b) if another Act is enacted in substitution for the Act – the other Act as amended and in force from time to time; and (c) statutory instruments in force under the Act, including, for example: (i) regulations; and (ii) orders; and (iii) manufacturing principles; and (iv) standards, including a medical device standard. therapeutic use, see section 3(1) of the Therapeutic Goods Act. unrestricted Schedule 4 substance, see section 8(1). unrestricted Schedule 8 substance, see section 10(1). unscheduled substance, for Part 2.7, Division 2, see section 105. use, for a Scheduled substance, see section 22(1). variation, for Part 3.5, see section 156. vending machine, for Part 2.7, Division 2, see section 105. veterinarian means a registered veterinarian under the Veterinarians Act 1994. wholesaler certificate of registration, see section 122. Note for section 5 The Interpretation Act 1978 contains definitions and other provisions that may be relevant to this Act. -- 27 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 2 Important concepts Subdivision 1 Substances to which this Act applies Medicines, Poisons and Therapeutic Goods Act 2012 12 Division 2 Important concepts Subdivision 1 Substances to which this Act applies 7 Meaning of Scheduled substance and related terms (1) A Scheduled substance is a substance to which a Schedule to the medicines and poisons standard applies. Note for subsection (1) See section 16 for when the medicines and poisons standard applies to a substance. (2) A reference to a Scheduled substance by number is a reference to a substance to which the Schedule of that number of the medicines and poisons standard applies. Example for subsection (2) A reference to a Schedule 4 substance is a reference to a substance to which Schedule 4 of the medicines and poisons standard applies. Note for section 7 Under the medicines and poisons standard, substances are classified according to the Schedules in which they are included. The following is a general description of the substances: (a) Schedule 2 substances may require advice from a pharmacist or retailer licensee to be used safely but are available without a prescription; (b) Schedule 3 substances require advice from a pharmacist to be used safely but are available without a prescription; (c) Schedule 4 substances are available from a pharmacy only on prescription and are commonly known as "prescription only medicines", including prescription animal remedies; (d) Schedule 5 substances have a low potential for causing harm; (e) Schedule 6 substances have a moderate potential for causing harm; (f) Schedule 7 substances have a high potential for causing harm and are available only to the holder of an authority for non-human use; (g) Schedule 8 substances are available only on prescription with restrictions to reduce abuse, misuse or dependence; (h) Schedule 9 substances are generally illegal substances that are subject to abuse or misuse; (i) Schedule 10 substances are substances, other than Schedule 9 substances, the supply and use of which are prohibited because of the degree of danger to health they represent. -- 28 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 2 Important concepts Subdivision 2 Medicines and poisons standard Medicines, Poisons and Therapeutic Goods Act 2012 13 8 Meaning of unrestricted Schedule 4 substance and restricted Schedule 4 substance (1) An unrestricted Schedule 4 substance is a substance other than a restricted Schedule 4 substance. (2) A restricted Schedule 4 substance is a substance declared under section 246(1)(a) to be a restricted Schedule 4 substance. 9 Meaning of pesticide A pesticide is a substance that is: (a) a Schedule 5, 6 or 7 substance; and (b) a pesticide as defined in the medicines and poisons standard. 10 Meaning of unrestricted Schedule 8 substance and restricted Schedule 8 substance (1) An unrestricted Schedule 8 substance is a Schedule 8 substance other than a restricted Schedule 8 substance. (2) A restricted Schedule 8 substance is a Schedule 8 substance declared under section 246(1)(b) to be a restricted Schedule 8 substance. 12 Meaning of prohibited substance A prohibited substance is any of the following substances: (a) a Schedule 9 substance; (b) a Schedule 10 substance. Subdivision 2 Medicines and poisons standard 14 Meaning of medicines and poisons standard (1) The medicines and poisons standard is the poisons standard as in force from time to time as modified under this section. (2) A regulation may declare a substance is taken to be included in, or excluded from, a provision of the medicines and poisons standard. (3) The declaration may impose restrictions in relation to dealings with the substance. -- 29 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 2 Important concepts Subdivision 2 Medicines and poisons standard Medicines, Poisons and Therapeutic Goods Act 2012 14 (4) For subsection (1), but subject to a modification under this section: (a) an amendment of a current poisons standard takes effect on the date of effect of the instrument of amendment under the Legislative Instruments Act 2003 (Cth); and (b) a new poisons standard takes effect on the date of effect of the standard under the Legislative Instruments Act 2003 (Cth). (5) In this section: current poisons standard means the current Poisons Standard as defined in section 52A of the Therapeutic Goods Act. new poisons standard means a document prepared under section 52D(2)(b) of the Therapeutic Goods Act. poisons standard means the document prepared under section 52D(2) of the Therapeutic Goods Act. 15 Interpretation provisions in medicines and poisons standard – application to Act (1) A term defined in the medicines and poisons standard has the same meaning in this Act. (2) A provision of the medicines and poisons standard relating to the interpretation of the standard applies in the interpretation of this Act. Examples for subsection (2) 1 Subject to stated exceptions, a reference in the medicines and poisons standard to a substance in a Schedule or Appendix to the standard includes: (a) a substance prepared from natural sources or artificially; and (b) every salt, active principle or derivative of the substance; and (c) a preparation or admixture containing any proportion of the substance. 2 Accordingly, subject to the exceptions, a reference to the substance in this Act includes a reference to those things. 3 In addition, unless there is a contrary intention, the standard does not apply to the following: (a) a substance in stated preparations or products; (b) stated substances; (c) some low concentrations of stated substances; (d) some impurities in pesticides. Note for section 15 Under section 30, this Act prevails if there is an inconsistency between this Act and the medicines and poisons standard. -- 30 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 2 Important concepts Subdivision 3 Dealing with Scheduled substances Medicines, Poisons and Therapeutic Goods Act 2012 15 16 When medicines and poisons standard applies to substances For this Act, a Schedule or Appendix to the medicines and poisons standard applies to a substance in a circumstance if: (a) the substance is included in the Schedule or Appendix; and (b) either: (i) the standard does not, in the circumstance, exclude the substance from the operation of the Schedule or Appendix; or (ii) a restriction in the standard applies in relation to the substance in the circumstance. Example for paragraph (b)(ii) If a Schedule 2 substance is listed as restricted "for human therapeutic use" and the substance is included only in that schedule, the standard applies to the substance only for human therapeutic use. Subdivision 3 Dealing with Scheduled substances 17 Meaning of deal with To deal with a Scheduled substance is to do any of the following: (a) manufacture the substance; (b) issue a prescription for the supply of the substance; (c) issue an administration order or supply order for administering or supplying the substance; (d) possess the substance; (e) supply the substance to another person; (f) administer the substance to another person or otherwise use the substance; (g) pack, label or advertise the substance; (h) store or transport the substance, including import it into the Territory; (i) destroy the substance; (j) something else prescribed by regulation. -- 31 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 2 Important concepts Subdivision 3 Dealing with Scheduled substances Medicines, Poisons and Therapeutic Goods Act 2012 16 18 Meaning of manufacture Manufacture includes the following: (a) produce; (b) make or prepare; (c) mix, extract or refine; (d) pack or repack for: (i) sale by wholesale; or (ii) use in connection with a business, industry, profession or trade. 19 Meaning of prescription A prescription, for a Scheduled substance, is a written instruction authorising the supply of the substance for: (a) administering to a particular person; or (b) administering to animals. Notes for section 19 1 A prescription may be issued electronically in accordance with the Electronic Transactions (Northern Territory) Act 2000. 2 Part 2.4, Division 1 contains provisions about who is authorised to issue prescriptions for Scheduled substances. Part 2.4, Division 2 contains other requirements about the content, issue and duration of prescriptions for Scheduled substances. 20 Meaning of possess Possess, in relation to a Scheduled substance, includes: (a) receive or obtain possession of the substance; and (b) have control over the disposition of the substance (whether with or without custody of it); and (c) have joint possession of the substance. 21 Meaning of supply and sell (1) Supply, of a Scheduled substance, includes: (a) sell the substance; and -- 32 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 2 Important concepts Subdivision 4 Health practitioners and others authorised to deal with Scheduled substances Medicines, Poisons and Therapeutic Goods Act 2012 17 (b) provide the substance on prescription. (2) However, supply of a Scheduled substance does not include issue a prescription for the supply of the substance. (3) Sell, in relation to a Scheduled substance, includes: (a) offer or expose the substance for sale; and (b) dispose of the substance by any method for value (or offer or expose the substance for disposal by any method for value). 22 Meaning of use and administer (1) Use, in relation to a Scheduled substance, includes administer the substance. (2) Administer, a Scheduled substance, is to apply or introduce the substance to the body of a person or animal. Subdivision 4 Health practitioners and others authorised to deal with Scheduled substances 23 Meaning of health practitioner and related terms (1) A health practitioner is a person registered under the Health Practitioner Regulation National Law to practise a health profession (other than as a student). (2) An authorised health practitioner is: (a) an NT doctor or NT nurse practitioner; or (b) another NT health practitioner prescribed by regulation. (3) An NT health practitioner is a health practitioner who practises in the Territory. (4) An NT specialist health practitioner is a person who: (a) is registered under the Health Practitioner Regulation National Law in a recognised specialty; and (b) practises in the Territory. -- 33 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 2 Important concepts Subdivision 4 Health practitioners and others authorised to deal with Scheduled substances Medicines, Poisons and Therapeutic Goods Act 2012 18 24 Meaning of doctor and NT doctor (1) A doctor is a medical practitioner. Note for subsection (1) A medical practitioner is defined in section 17 of the Interpretation Act 1978 to be a person registered under the Health Practitioner Regulation National Law to practise in the medical profession (other than as a student). (2) An NT doctor is a doctor who practises in the Territory. 25 Meaning of nurse, midwife and related terms (1) A nurse is a health practitioner registered under the Health Practitioner Regulation National Law to practise in the nursing profession (other than as a student). (2) A nurse practitioner is a nurse whose registration under the Health Practitioner Regulation National Law is endorsed as being qualified to practise as a nurse practitioner. (3) An NT nurse practitioner is a nurse practitioner who practises in the Territory. (5) A midwife is a health practitioner registered under the Health Practitioner Regulation National Law to practise in the midwifery profession (other than as a student). (6) An endorsed midwife is a midwife whose registration under the Health Practitioner Regulation National Law is endorsed as being qualified to possess, issue a prescription for the supply of, supply or administer a Scheduled substance. 26 Meaning of dentist and dental therapist (1) A dentist is a person registered under the Health Practitioner Regulation National Law: (a) to practise in the dental profession as a dentist (other than as a student); and (b) in the dentists division of that profession. (2) A dental therapist is a person registered under the Health Practitioner Regulation National Law: (a) to practise in the dental profession as a dental therapist (other than as a student); and (b) in the dental therapists division of that profession. -- 34 of 187 -- Chapter 1 Introduction Part 1.2 Interpretation Division 2 Important concepts Subdivision 4 Health practitioners and others authorised to deal with Scheduled substances Medicines, Poisons and Therapeutic Goods Act 2012 19 (3) A dental hygienist is a person registered under the Health Practitioner Regulation National Law: (a) to practise in the dental profession as a dental hygienist (other than as a student); and (b) in the dental hygienists division of that profession. (4) An oral health therapist is a person registered under the Health Practitioner Regulation National Law: (a) to practise in the dental profession as an oral health therapist (other than as a student); and (b) in the oral health therapists division of that profession. 27 Meaning of optometrist, pharmacist and podiatrist (1) An optometrist is a person registered under the Health Practitioner Regulation National Law to practise in the optometry profession (other than a student). (2) A pharmacist is a person registered under the Health Practitioner Regulation National Law to practise in the pharmacy profession (other than a student). (3) A podiatrist is a person registered under the Health Practitioner Regulation National Law to practise in the podiatry profession (other than a student). 28 Meaning of Aboriginal and Torres Strait Islander health practitioner An Aboriginal and Torres Strait Islander health practitioner is a person registered under the Health Practitioner Regulation National Law to practise in the Aboriginal and Torres Strait Islander health practice profession (other than as a student). 28A Meaning of paramedic A paramedic is a person registered under the Health Practitioner Regulation National Law to practise in the paramedicine profession (other than as a student). -- 35 of 187 -- Chapter 1 Introduction Part 1.3 Application of Act Medicines, Poisons and Therapeutic Goods Act 2012 20 Part 1.3 Application of Act 29 Act binds Crown (1) This Act binds the Crown in right of the Territory and, to the extent the legislative power of the Legislative Assembly permits, the Crown in all its other capacities. (2) However, this Act does not make the Crown liable to be prosecuted for an offence. 30 Inconsistency between Act and medicines and poisons standard This Act prevails if there is an inconsistency between this Act and the medicines and poisons standard. 31 Relationship with Health Practitioner Regulation National Law A health practitioner's authorisation under this Act to deal with a Scheduled substance is subject to the conditions or other restrictions to which the health practitioner is subject under the Health Practitioner Regulation National Law. Note for section 31 Part 2.3, Division 1 and Part 2.4, Division 1 authorise health practitioners in the Territory to possess, supply, administer and issue prescriptions for Scheduled substances they are qualified to do under the Health Practitioner Regulation National Law. In particular, this includes an authorisation for a qualification endorsed on a health practitioner's certificate of registration in addition to the specific authorisations, see sections 73 and 86. 31A Relationship with Hemp Industry Act 2019 (1) This Act does not affect the operation of the Hemp Industry Act 2019 or make unlawful anything done in accordance with that Act. (2) Without limiting subsection (1), this Act does not apply to processed low THC hemp as defined in section 4A(3) of the Misuse of Drugs Act 1990. -- 36 of 187 -- Chapter 1 Introduction Part 1.3 Application of Act Medicines, Poisons and Therapeutic Goods Act 2012 21 32 Relationship with Misuse of Drugs Act 1990 This Act does not affect the operation of the Misuse of Drugs Act 1990 in relation to Scheduled substances that are dangerous drugs as defined in that Act except to the extent to which this Act provides otherwise (whether expressly or by necessary implication). Notes for section 32 1 Under the Misuse of Drugs Act 1990, it is unlawful to manufacture, possess, supply or administer a dangerous drug. Some prohibited substances and some Schedule 4 and 8 substances are dangerous drugs. However, the manufacture, possession, supply or administration of those substances may be lawful under that Act because a manufacturer certificate of registration, prohibited substance authorisation or Schedule 8 authorisation authorises the activity, see sections 121, 127 and 128. 2 In addition, Part 2.3 authorises the possession, supply and use of Schedule 8 substances by some people in some circumstances. 33 Application of Criminal Code Part IIAA of the Criminal Code applies to an offence against this Act. Notes for section 33 1 Part IIAA of the Criminal Code states the general principles of criminal responsibility, establishes general defences, and deals with burden of proof. It also defines, or elaborates on, certain concepts commonly used in the creation of offences. 2 In particular, under section 43BE of the Criminal Code, a person is not criminally responsible for an offence if the conduct constituting the offence is justified or excused by or under a law. Accordingly, the authorisations for health practitioners and others to deal with Scheduled substances under Part 2.3 provide a defence to an offence against Part 2.1 or 2.2. -- 37 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.1 Requirements for registration and licensing of manufacturers, wholesalers and retailers Medicines, Poisons and Therapeutic Goods Act 2012 22 Chapter 2 Dealing with Scheduled substances Part 2.1 Requirements for registration and licensing of manufacturers, wholesalers and retailers 34 Manufacturer of certain Scheduled substances to be registered (1) A person commits an offence if the person: (a) manufactures a Scheduled substance, other than a Schedule 5 or 6 substance, at a place; and (b) is not authorised under a manufacturer certificate of registration to manufacture the substance at the place. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Subsection (1) does not apply to: (a) a health practitioner or veterinarian preparing or mixing the substance for the treatment of a person or animal in the course of practising in the health practitioner's health profession or providing veterinary services; or (b) an employee of a health practitioner or veterinarian who prepares or mixes the substance under the direct supervision of a health practitioner or veterinarian for the treatment of a person or animal in the course of practising in the health practitioner's health profession or providing veterinary services. (3) In addition, subsection (1) does not apply to a person if: (a) the substance is a Schedule 4 or 8 substance; and (b) the substance is supplied to the person under a Schedule 4 or 8 authorisation; and (c) the person prepares the substance for self-administration; and (d) the person does not supply it to anyone else. -- 38 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 1 Schedule 3 substances Medicines, Poisons and Therapeutic Goods Act 2012 23 35 Wholesaler of certain Scheduled substances to be registered (1) A person commits an offence if the person: (a) sells by wholesale a Scheduled substance, other than a Schedule 5 or 6 substance, from a place; and (b) the sale is not authorised under a wholesaler certificate of registration. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Subsection (1) does not apply to a sale of the substance by a pharmacist in the course of practising in the pharmacy profession. 36 Retailer of Schedule 2 and 7 substances to be licensed (1) A person commits an offence if the person: (a) sells by retail a Schedule 2 or 7 substance from a place; and (b) the sale is not authorised under a retailer licence. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Subsection (1) does not apply to a pharmacist selling a Schedule 2 substance in the course of practising in the pharmacy profession. Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 1 Schedule 3 substances 37 Supply of Schedule 3 substance (1) A person commits an offence if: (a) the person intentionally supplies a substance to another person; and (b) the substance is a Schedule 3 substance and the person is reckless in relation to that circumstance; and -- 39 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 2 Schedule 4 substances Medicines, Poisons and Therapeutic Goods Act 2012 24 (c) the supply of the substance by the person is not authorised under this Act. Maximum penalty: 50 penalty units. (2) Strict liability applies to subsection (1)(c). 38 Administration of Schedule 3 substance (1) A person commits an offence if: (a) the person intentionally administers a substance to another person; and (b) the substance is a Schedule 3 substance and the person is reckless in relation to that circumstance; and (c) the administration of the substance by the person is not authorised under this Act. Maximum penalty: 50 penalty units. (2) Strict liability applies to subsection (1)(c). (3) It is a defence to a prosecution for an offence against subsection (1) if the defendant believed on reasonable grounds that: (a) the person to whom the Schedule 3 substance was administered was in danger of dying or of suffering a serious disability; and (b) the administration of the Schedule 3 substance to that person was required to prevent the person from dying or suffering a serious disability. Note for subsection (3) The defendant has an evidential burden in relation to this defence (see section 43BU of the Criminal Code). Division 2 Schedule 4 substances 39 Possession A person must not possess a Schedule 4 substance unless the possession is authorised under: (a) a certificate of registration; or (b) a Schedule 4 authorisation; or -- 40 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 3 Pesticides and other Schedule 7 substances Medicines, Poisons and Therapeutic Goods Act 2012 25 (c) a research authorisation; or (d) a medical kit authorisation. Maximum penalty: 100 penalty units or imprisonment for 12 months. 40 Supply A person must not supply a Schedule 4 substance to someone unless the supply is authorised under: (a) a certificate of registration; or (b) a medical kit authorisation. Maximum penalty: 200 penalty units or imprisonment for 2 years. 41 Use A person must not use a Schedule 4 substance unless the use is authorised under: (a) a Schedule 4 authorisation; or (b) a research authorisation; or (c) a medical kit authorisation. Maximum penalty: 100 penalty units or imprisonment for 12 months. Division 3 Pesticides and other Schedule 7 substances 42 Supply by authorised persons only A person must not supply a Schedule 7 substance to someone unless the supply is authorised under: (a) a certificate of registration; or (b) a retailer licence. Maximum penalty: 100 penalty units or imprisonment for 12 months. -- 41 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 3 Pesticides and other Schedule 7 substances Medicines, Poisons and Therapeutic Goods Act 2012 26 43 Supply to authorised persons only (1) A person (the supplier) must not supply a Schedule 7 substance to someone (the recipient) unless: (a) the recipient shows the supplier one of the following authorising the recipient to use the substance: (i) a Schedule 7 authorisation; (ii) a pest management technician licence; (iii) a research authorisation; (iv) a licence endorsed for the substance under Part 5, Division 2 of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004; (v) an S7 authorisation under the Agricultural and Veterinary Chemicals (Control of Use) Regulations 2005; or (b) the supplier is satisfied, by a statutory declaration made by the recipient, that the recipient: (i) intends to use the substance only in a place outside the Territory; and (ii) is authorised under the law of that place to use the substance; or (c) the recipient is exempted by regulation from the requirement to hold: (i) a Schedule 7 authorisation for the use of the substance; or (ii) a pest management technician licence for the use of the substance. Maximum penalty: 100 penalty units or imprisonment for 12 months. (2) If the supplier supplies a Schedule 7 substance to the recipient under subsection (1)(b), the supplier must keep the declaration for 2 years after the date of the supply. Maximum penalty: 50 penalty units. (3) An offence against subsection (2) is an offence of strict liability. -- 42 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 3 Pesticides and other Schedule 7 substances Medicines, Poisons and Therapeutic Goods Act 2012 27 (4) It is a defence to a prosecution for an offence against subsection (2) if the defendant establishes a reasonable excuse. 44 Use (1) A person must not use a pesticide in carrying out pest control operations for fee or reward unless: (a) the use is authorised under: (i) a pest management technician licence; or (ii) a licence under Part 5, Division 2 of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004; or (iii) an S7 authorisation under the Agricultural and Veterinary Chemicals (Control of Use) Regulations 2005; or (b) the person: (i) is employed by the holder of a pest management technician licence; and (ii) uses the pesticide under the direct supervision of the licensee. Maximum penalty: 100 penalty units or imprisonment for 12 months. (2) A person must not use a Schedule 7 substance (other than a pesticide) unless the use is authorised under: (a) a Schedule 7 authorisation; or (b) a research authorisation. Maximum penalty: 100 penalty units or imprisonment for 12 months. (3) Subsections (1) and (2) do not apply if the person is exempted by regulation from the requirement to hold an authority mentioned in the subsection for the use of the substance. -- 43 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 4 Schedule 8 substances Subdivision 1 Unrestricted Schedule 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 28 Division 4 Schedule 8 substances Subdivision 1 Unrestricted Schedule 8 substances 45 Possession A person must not possess an unrestricted Schedule 8 substance unless the possession of the substance is authorised under: (a) a certificate of registration; or (b) a Schedule 8 authorisation; or (c) a research authorisation; or (d) a medical kit authorisation. Maximum penalty: 100 penalty units or imprisonment for 12 months. 46 Supply generally A person must not supply an unrestricted Schedule 8 substance to someone unless the supply is authorised under a certificate of registration. Maximum penalty: 200 penalty units or imprisonment for 2 years. 47 Use generally A person must not use an unrestricted Schedule 8 substance unless the use is authorised under: (a) a Schedule 8 authorisation; or (b) a research authorisation; or (c) a medical kit authorisation. Maximum penalty: 100 penalty units or imprisonment for 12 months. -- 44 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 4 Schedule 8 substances Subdivision 2 Restricted Schedule 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 29 48 Supplying and administering in prohibited circumstances (1) An authorised health practitioner must not supply or administer an unrestricted Schedule 8 substance to someone in a prohibited circumstance mentioned in subsection (2) unless the supply or administration is authorised under: (a) a Schedule 8 authorisation; or (b) a Schedule 8 exemption. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Each of the following is a prohibited circumstance for the supply or administration of an unrestricted Schedule 8 substance: (a) for treating a person's addiction to a substance; (b) for another purpose prescribed by regulation. Subdivision 2 Restricted Schedule 8 substances 49 Possession A person must not possess a restricted Schedule 8 substance unless the possession is authorised under: (a) a certificate of registration; or (b) a Schedule 8 authorisation for an authorised purpose; or (c) a Schedule 8 exemption for an authorised purpose; or (d) a research authorisation; or (e) a medical kit authorisation. Maximum penalty: 200 penalty units or imprisonment for 2 years. Note for section 49 Under section 139(1)(b), a Schedule 8 authorisation for the possession of a restricted Schedule 8 substance may be issued only to an authorised health practitioner for supply or administration for an authorised purpose. In addition, under section 245, the CHO may issue a Schedule 8 exemption to an authorised health practitioner for the possession of a restricted Schedule 8 substance for its supply for an authorised purpose. -- 45 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 4 Schedule 8 substances Subdivision 2 Restricted Schedule 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 30 50 Supply A person must not supply a restricted Schedule 8 substance to someone unless the supply is authorised under: (a) a certificate of registration; or (b) a Schedule 8 authorisation for an authorised purpose; or (c) a Schedule 8 exemption for an authorised purpose. Maximum penalty: 400 penalty units or imprisonment for 4 years. Note for section 50 Under section 139(1)(b), a Schedule 8 authorisation for the supply of a restricted Schedule 8 substance may be issued only to an authorised health practitioner for supply for an authorised purpose. In addition, under section 245, the CHO may issue a Schedule 8 exemption to an authorised health practitioner for the supply of a restricted Schedule 8 substance for an authorised purpose. 51 Use A person must not use a restricted Schedule 8 substance unless the use is authorised under: (a) a Schedule 8 authorisation for an authorised purpose; or (b) a Schedule 8 exemption for an authorised purpose; or (c) a research authorisation; or (d) a medical kit authorisation. Maximum penalty: 200 penalty units or imprisonment for 2 years. Note for section 51 Under section 139(1)(b), a Schedule 8 authorisation for the administration of a restricted Schedule 8 substance may be issued only to an authorised health practitioner for administration for an authorised purpose. In addition, under section 245, the CHO may issue a Schedule 8 exemption to an authorised health practitioner for the administration of a restricted Schedule 8 substance for an authorised purpose. -- 46 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 5 Prohibited substances Medicines, Poisons and Therapeutic Goods Act 2012 31 Division 5 Prohibited substances 52 Possession (1) A person must not possess a prohibited substance unless the possession is authorised under: (a) a certificate of registration; or (b) a prohibited substance authorisation; or (c) a research authorisation. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Subsection (1) does not apply to a person possessing the substance if: (a) the substance is subject to an exemption under section 18 of the Therapeutic Goods Act for use of the substance solely for experimental purposes in humans; or (b) the person uses the substance in the treatment of another person or experimental purposes in humans under an approval given under section 19 of the Therapeutic Goods Act. Note for section 52 Under section 140, a prohibited substance authorisation for the possession of a prohibited substance may be issued only to: (a) for etorphine – a veterinarian or other prescribed person for use to sedate animals; or (b) for other prohibited substances – an authorised health practitioner for administration for the treatment of a person's terminal illness. 53 Supply A person must not supply a prohibited substance to someone unless the supply is authorised under: (a) a certificate of registration; or -- 47 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances Division 5 Prohibited substances Medicines, Poisons and Therapeutic Goods Act 2012 32 (b) a prohibited substance authorisation. Maximum penalty: 500 penalty units or imprisonment for 5 years. Note for section 53 Under section 140, a prohibited substance authorisation for the supply of a prohibited substance may be issued only to: (a) for etorphine – a veterinarian or other prescribed person for use to sedate animals; or (b) for other prohibited substances – an authorised health practitioner for administration for the treatment of a person's terminal illness. 54 Use (1) A person must not use a prohibited substance unless the use is authorised under: (a) a prohibited substance authorisation; or (b) a research authorisation. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Subsection (1) does not apply to a person using the substance if: (a) the substance is subject to an exemption under section 18 of the Therapeutic Goods Act for use of the substance solely for experimental purposes in humans; or (b) the person uses the substance in the treatment of another person or experimental purposes in humans under an approval given under section 19 of the Therapeutic Goods Act. Note for section 54 Under section 140, a prohibited substance authorisation for the use of a prohibited substance may be issued only to: (a) for etorphine – a veterinarian or other prescribed person to sedate animals; or (b) for other prohibited substances – an authorised health practitioner for the treatment of a person's terminal illness. -- 48 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 2 Pharmacists Medicines, Poisons and Therapeutic Goods Act 2012 33 Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 1 Authorised health practitioners 55 Schedule 4 substances and unrestricted Schedule 8 substances (1) An authorised health practitioner may, in the course of practising in the health practitioner's health profession: (a) supply or administer a Schedule 4 substance or unrestricted Schedule 8 substance to another person; and (b) possess the substance for those purposes. (2) However, the health practitioner must supply and administer a restricted Schedule 4 substance in accordance with the conditions stated in the declaration of the substance as a restricted Schedule 4 substance. Subdivision 2 Pharmacists 56 Possessing Schedule 4 and 8 substances A pharmacist may, in the course of practising in the pharmacy profession, possess Schedule 4 and 8 substances for supply: (a) under this Subdivision; or (b) in another circumstance prescribed by regulation. 57 Supplying Schedule 4 and 8 substances – general (1) A pharmacist may, in the course of practising in the pharmacy profession, supply a Schedule 4 or 8 substance: (a) to an authorised prescriber for the substance; or (b) to a person on a prescription issued by an authorised prescriber (other than an interstate prescriber) for the substance; or -- 49 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 2 Pharmacists Medicines, Poisons and Therapeutic Goods Act 2012 34 (c) on a written supply order for the substance to: (i) a person who was a patient of a hospital on the person's discharge from the hospital; or (ii) a nurse employed at a residential facility for administration to a resident at the facility; or (iii) the person in charge of a declared place for administration to a person receiving medical treatment at the place; or (d) to another pharmacist for the other pharmacist to supply the substance in the course of practising in the pharmacy profession; or (e) to the master of a ship, who is authorised or required under the Navigation Act 2012 (Cth) to carry the substance on board the ship, on the written request of the master or ship's medical officer; or (f) to the holder of a research authorisation or medical kit authorisation for the substance; or (g) for a Schedule 4 substance – to the holder of a Schedule 4 authorisation; or (h) to a person prescribed by regulation. Note for subsection (1)(d) A pharmacist is not required to have a wholesaler certificate of registration for the wholesale supply of the substances in the course of practising the pharmacy profession, see section 35(2). Note for subsection (1)(e) Orders made by the Australian Maritime Safety Authority under the Navigation Act 1912 (Cth) also authorise some people to deal with the substance. Accordingly, a person who deals with the substance in accordance with the orders is not criminally responsible for an offence against Part 2.1, see section 43BE of the Criminal Code. (2) In addition, a pharmacist employed at a hospital may, in the course of practising in the pharmacy profession, supply a Schedule 4 or 8 substance to one of the following health practitioners on the written requisition of the health practitioner containing the information prescribed by regulation: (a) a doctor, dentist, nurse practitioner or endorsed midwife employed or engaged at the hospital; -- 50 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 2 Pharmacists Medicines, Poisons and Therapeutic Goods Act 2012 35 (b) the nurse in charge of a ward or department of the hospital. 58 Supplying Schedule 4 and 8 substances – prescription of interstate prescribers (1) A pharmacist may, in the course of practising in the pharmacy profession, supply an unrestricted Schedule 4 substance to a person on a prescription issued by an interstate prescriber. (2) A pharmacist may, in the course of practising in the pharmacy profession, supply a Schedule 8 substance or restricted Schedule 4 substance to a person on a prescription issued by an interstate prescriber in accordance with: (a) the conditions prescribed by regulation applying to the supply; or (b) an approval under section 253. 59 Supplying unrestricted Schedule 4 substance in emergency for patient previously supplied on prescription (1) A pharmacist may, in the course of practising in the pharmacy profession, supply an unrestricted Schedule 4 substance to a person (the patient), or another person who acts for the patient (the agent) if: (a) the pharmacist is reasonably satisfied supplying the substance is justified because of urgent circumstances; and (b) the pharmacist, or another pharmacist, has previously supplied the substance for administration to or by the patient on the prescription of an authorised prescriber for the substance; and (c) for a supply to the agent: (i) the agent gives the pharmacist the name and contact details of the authorised prescriber; and (ii) the agent produces to the pharmacist proof of the agent's identity. (2) Subsection (1) does not authorise the pharmacist to supply more than: (a) 7 days supply of the substance administered at the daily dose the pharmacist reasonably believes the authorised prescriber would recommend be administered to the patient; or -- 51 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 2 Pharmacists Medicines, Poisons and Therapeutic Goods Act 2012 36 (b) the smallest primary pack of the substance that has been packaged and labelled by the substance's manufacturer in compliance with the medicines and poisons standard. 59A Supplying unrestricted Schedule 4 substance – continued dispensing A pharmacist may, in the course of practising in the pharmacy profession, supply an unrestricted Schedule 4 substance to a person if: (a) the substance is a pharmaceutical benefit that is covered by an instrument made under section 89A(3) of the National Health Act 1953 (Cth); and (b) the supply is made in accordance with the conditions that are specified in that instrument as if the pharmacist were an approved pharmacist. 60 Supplying unrestricted Schedule 4 substance for patient in residential care (1) A pharmacist may, in the course of practising in the pharmacy profession, supply an unrestricted Schedule 4 substance to a person (the agent), for administration to or by another person for whom the agent acts (the patient) if: (a) the pharmacist has previously supplied the substance to the agent or patient for administration to the patient on the prescription of an authorised prescriber for the substance; and (b) the pharmacist is satisfied the patient: (i) is in residential care; and (ii) the substance is administered in accordance with a therapeutic regime decided by a health practitioner for treatment of a chronic medical condition; and (c) for a supply to the agent: (i) the agent gives the pharmacist the name and contact details of the authorised prescriber; and (ii) the agent produces to the pharmacist proof of the agent's identity. -- 52 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 2 Pharmacists Medicines, Poisons and Therapeutic Goods Act 2012 37 (2) Subsection (1) does not authorise the pharmacist to supply more than: (a) 7 days supply of the substance administered at the daily dose the pharmacist reasonably believes an authorised prescriber would recommend be administered to the patient; or (b) the smallest primary pack of the substance that has been packaged and labelled by the substance's manufacturer in compliance with the medicines and poisons standard. 61 Supplying Schedule 4 and 8 substances on oral request of authorised prescriber (1) A pharmacist may, in the course of practising in the pharmacy profession, supply a Schedule 4 or 8 substance to a person (the patient), or another person who acts for the patient (the agent) if the pharmacist: (a) has been orally requested to supply the substance to: (i) the patient for self-administration or administration to the patient by someone else; or (ii) the agent for administration to the patient by the agent or someone else; and (b) is satisfied the person making the request is an authorised prescriber for the substance. (2) Subsection (1) does not authorise the pharmacist to supply more than 7 days supply of the substance administered at the daily dose stated by the authorised prescriber. -- 53 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 3 Other health practitioners Medicines, Poisons and Therapeutic Goods Act 2012 38 Subdivision 3 Other health practitioners 63 Administering Schedule 4 or 8 substances under administration order – Aboriginal and Torres Strait health practitioners, nurses, midwives and pharmacists (1) Subject to subsection (2), if an authorised prescriber has, by administration order, authorised an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist (the practitioner) to administer a Schedule 4 or 8 substance to another person, the practitioner may, in the course of practising in the practitioner's health profession, administer the substance to the person. Note for subsection (1) See section 92(1)(a)(i) to (iv) in relation to the persons to whom an authorised prescriber for a Schedule 4 or 8 substance may, by administration order, authorise the administration of the substance to. (2) The practitioner must administer the substance in accordance with any instructions given by the authorised prescriber. (3) A practitioner who is authorised to administer a Schedule 4 or 8 substance to a person under this section may, in the course of practising in the practitioner's health profession, possess the substance for that purpose. 64 Administering Schedule 4 or 8 substances supplied on supply order – nurses employed at residential facilities (1) Subject to subsection (2), a nurse employed at a residential facility may, in the course of practising in the nursing profession, administer a Schedule 4 or 8 substance to a resident at the facility if: (a) the substance was supplied by a pharmacist on a supply order issued by an authorised prescriber; and (b) the prescriber authorised the supply of the substance for the purpose of its administration to the resident. Notes for subsection (1) 1 Under section 92(1)(b)(ii), an authorised prescriber for a Schedule 4 or 8 substance may, by supply order, authorise the supply of the substance by a pharmacist to a nurse employed at a residential facility for administration to a resident at the facility. 2 Under section 57(1)(c)(ii), a pharmacist may supply a Schedule 4 or 8 substance on a written supply order for the substance to a nurse employed at a residential facility for administration to a resident at the facility. -- 54 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 3A Administering, supplying and possessing Scheduled substances under SSTP Medicines, Poisons and Therapeutic Goods Act 2012 39 (2) The nurse must administer the substance in accordance with any instructions for its administration specified by the authorised prescriber in the supply order. (3) A nurse who is authorised to administer a Schedule 4 or 8 substance to a resident at a residential facility under this section may, in the course of practising in the nursing profession, possess the substance for that purpose. 66 Dentists A dentist may, in the course of practising in the dental profession as a dentist: (a) supply or administer a Schedule 4 substance or unrestricted Schedule 8 substance to another person; and (b) possess the substance for those purposes. 68 Optometrists An optometrist may, in the course of practising in the optometry profession: (a) supply or administer an unrestricted Schedule 4 substance to another person; and (b) possess the substance for those purposes. 69 Podiatrists A podiatrist may, in the course of practising in the podiatry profession: (a) supply or administer a Schedule 4 substance or unrestricted Schedule 8 substance to another person; and (b) possess the substance for those purposes. Subdivision 3A Administering, supplying and possessing Scheduled substances under SSTP 70 Definitions In this Subdivision: approved SSTP means an SSTP for which an approval under section 254 is in effect. -- 55 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 3A Administering, supplying and possessing Scheduled substances under SSTP Medicines, Poisons and Therapeutic Goods Act 2012 40 prescribed health practitioner means a health practitioner of a type prescribed by regulation under section 70A(1). prescribed healthcare worker means a person who is a member of a class of persons prescribed by regulation under section 70A(2). 70A Prescribed health practitioners and healthcare workers (1) The regulations may prescribe a type of health practitioner that may be authorised under this Subdivision to administer or supply a Schedule 4 or 8 substance in accordance with an approved SSTP. (2) The regulations may prescribe a class of persons that provide health services, other than a health practitioner, that may be authorised under this Subdivision to administer or supply a Schedule 3, 4 or 8 substance in accordance with an approved SSTP. Note for section 70A For the administration or supply of a Schedule 3 substance by a health practitioner, see sections 71 and 72. 70B Form and content of SSTP (1) A Scheduled substance treatment protocol is a document setting out protocols for the administration or supply of: (a) a Schedule 4 or 8 substance by the prescribed health practitioner, or the class of prescribed health practitioners, specified in the document in the circumstances specified in the document; or (b) a Schedule 3, 4 or 8 substance by the prescribed healthcare worker, or the class of prescribed healthcare workers, specified in the document in the circumstances specified in the document. (2) An SSTP must specify the following matters: (a) the prescribed health practitioner or prescribed healthcare worker, or the class of prescribed health practitioners or prescribed healthcare workers, in relation to which it applies; (b) if the SSTP applies to a prescribed health practitioner or a class of prescribed health practitioner – the Schedule 4 or 8 substance in relation to which it applies; -- 56 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 3A Administering, supplying and possessing Scheduled substances under SSTP Medicines, Poisons and Therapeutic Goods Act 2012 41 (c) if the SSTP applies to a prescribed healthcare worker or a class of prescribed healthcare worker – the Schedule 3, 4 or 8 substance in relation to which it applies; (d) the circumstances in which the substance may be administered or supplied to another person in accordance with the SSTP, including with reference to the matters prescribed by regulation; (e) any other matter prescribed by regulation. (3) For subsection (2)(a), a class of prescribed health practitioners or class of prescribed healthcare workers may be identified in an SSTP by reference to one or more of the following criteria: (a) a qualification held, or training that has been undertaken, by members of the class; (b) the employment circumstances of members of the class; (c) a place at which members of the class practise their health profession or provide health services; (d) any other criteria prescribed by regulations. Note for section 70B An SSTP is required to be approved by the CHO under section 254 before a prescribed health practitioner or prescribed healthcare worker to which the SSTP applies may administer or supply the specified Scheduled substance in accordance with it. 70C Administering, supplying and possessing Schedule 4 or 8 substance under SSTP – prescribed health practitioners (1) Subject to subsection (2), a prescribed health practitioner may, in the course of practising in the practitioner's health profession, administer a Schedule 4 or 8 substance to another person if: (a) an approved SSTP for the administration of the substance applies to the practitioner; and (b) the administration of the substance to the other person is in the circumstances specified in the approved SSTP. (2) The prescribed health practitioner must administer the substance in accordance with the approved SSTP. -- 57 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 3A Administering, supplying and possessing Scheduled substances under SSTP Medicines, Poisons and Therapeutic Goods Act 2012 42 (3) Subject to subsection (4), a prescribed health practitioner may, in the course of practising in the practitioner's health profession, supply a Schedule 4 or 8 substance to another person if: (a) an approved SSTP for the supply of the substance applies to the practitioner; and (b) the supply of the substance to the other person is in the circumstances specified in the approved SSTP. (4) The prescribed health practitioner must supply the substance in accordance with the approved SSTP. (5) A prescribed health practitioner who is authorised to administer or supply a Schedule 4 or 8 substance to another person under this section may, in the course of practising in the practitioner's health profession, possess the substance for that purpose. 70D Administering, supplying and possessing Schedule 3, 4 or 8 substance under SSTP – prescribed healthcare workers (1) Subject to subsection (2), a prescribed healthcare worker may, in the course of providing health services, administer a Schedule 3, 4 or 8 substance to another person if: (a) an approved SSTP for the administration of the substance applies to the healthcare worker; and (b) the administration of the substance to the other person is in the circumstances specified in the approved SSTP. (2) The prescribed healthcare worker must administer the substance in accordance with the approved SSTP. (3) Subject to subsection (4), a prescribed healthcare worker may, in the course of providing health services, supply a Schedule 3, 4 or 8 substance to another person if: (a) an approved SSTP for the supply of the substance applies to the healthcare worker; and (b) the supply of the substance to the other person is in the circumstances specified in the approved SSTP. (4) The prescribed healthcare worker must supply the substance in accordance with the approved SSTP. -- 58 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 5 Additional qualifications for health practitioners under Health Practitioner Regulation National Law Medicines, Poisons and Therapeutic Goods Act 2012 43 (5) A prescribed healthcare worker who is authorised to administer or supply a Schedule 4 or 8 substance to another person under this section may, in the course of providing health services, possess the substance for that purpose. Subdivision 4 Special provisions for health practitioners to supply and administer Schedule 3 substances 71 Supplying Schedule 3 substances (1) Subject to subsection (4), a health practitioner may, in the course of practising in the practitioner's health profession, supply a Schedule 3 substance to another person (the recipient). (2) A health practitioner who supplies a Schedule 3 substance under subsection (1) must, at the time of the supply, give the recipient adequate instructions (written or oral) for the administration of the substance. (3) The health practitioner must give the instructions to the recipient under subsection (2) even if the Schedule 3 substance that is supplied is to be used by a person other than the recipient. (4) Subsection (1) does not authorise the sale by retail of a Schedule 3 substance by a health practitioner other than a pharmacist. 72 Administering Schedule 3 substances A health practitioner may, in the course of practising in the practitioner's health profession, administer a Schedule 3 substance to another person. Subdivision 5 Additional qualifications for health practitioners under Health Practitioner Regulation National Law 73 Endorsement on health practitioner's registration for additional qualifications (1) This section applies to a health practitioner whose registration under the Health Practitioner Regulation National Law is endorsed as qualified to possess, supply or administer, a Scheduled substance (the endorsed qualification) in addition to an authorisation under this Division. Note for subsection (1) Part 7, Division 3 of the Health Practitioner Regulation National Law deals with the endorsement of registration under the Law. -- 59 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 2 Other authorisations Medicines, Poisons and Therapeutic Goods Act 2012 44 (2) The health practitioner may, in the course of practising in the health practitioner's health profession, deal with the Scheduled substance in accordance with the endorsed qualification. (3) The health practitioner's authorisation under subsection (2) is subject to the conditions or other restrictions prescribed by regulation. Division 2 Other authorisations 74 Veterinarians (1) A veterinarian may, in the course of providing veterinary services, deal with Scheduled substances as follows: (a) supply or administer a Schedule 3, 4 or 8 substance for the treatment of animals; (b) possess the substance for the purpose mentioned in paragraph (a). (2) However, the veterinarian must deal with the substance in accordance with the conditions of the veterinarian's registration. 75 Supplying and administering Schedule 3 substance supplied by health practitioner (1) If a health practitioner has supplied a Schedule 3 substance to a person (the recipient) for use by a person other than the recipient, the recipient may supply, but not sell, the substance to the person. (2) If a health practitioner has supplied a Schedule 3 substance for administration to a person (the patient), any person may administer the substance to the patient in accordance with the instructions given by the health practitioner. Note for subsection (2) See section 71 in relation to the supply of a Schedule 3 substance by a health practitioner. 76 Possessing and administering lawfully supplied Schedule 4 and 8 substances for administering to patients (1) This section applies if, under this Act or an Act of the Commonwealth, a State or another Territory, a health practitioner supplies a Schedule 4 or 8 substance for administering to a person (the patient). -- 60 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 2 Other authorisations Medicines, Poisons and Therapeutic Goods Act 2012 45 (2) The patient may: (a) self-administer the supplied substance in accordance with the instructions of the health practitioner; and (b) possess the supplied substance for self-administration. (3) In addition, another person may: (a) administer the supplied substance to the patient in accordance with the instructions of the health practitioner; and (b) possess the supplied substance for administering to the patient. Example of application of subsection (3) A doctor issues a prescription for the supply of a restricted Schedule 4 substance for administering to an elderly patient. A child or carer of the patient does not commit an offence against section 41(1) merely because the child or carer administers the substance to the patient in accordance with the doctor's instructions. 77 Possessing and administering lawfully supplied Schedule 4 and 8 substances for administering to animals (1) This section applies if, under this Act or an Act of the Commonwealth, a State or another Territory, a pharmacist or veterinarian supplies a Schedule 4 or 8 substance for administering to animals under a person's control. (2) The person may: (a) administer the supplied substance to the animals in accordance with the instructions of the pharmacist or veterinarian who authorised the supply; and (b) possess the supplied substance for administering it to the animals. (3) However, subsection (2) does not apply to the administration of the supplied substance by the pharmacist or veterinarian. (4) In this section: veterinarian includes a person registered or otherwise authorised under an Act of a State or another Territory to provide veterinary services. -- 61 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 2 Other authorisations Medicines, Poisons and Therapeutic Goods Act 2012 46 78 Possessing, supplying and administering Schedule 3, 4 and 8 substances under emergency authorisation While an emergency authorisation is in force under section 251, a person who is authorised, or a member of a class of health practitioners that is authorised, under the authorisation may, in accordance with the authorisation: (a) supply or administer the Schedule 3, 4 or 8 substances stated in the authorisation; and (b) possess the substances for those purposes. 79 Possessing Scheduled substances for delivery (1) This section applies to a person (the delivery person) who is: (a) engaged by an authorised supplier to transport and deliver a Scheduled substance to someone who is authorised under this Act to possess the substance (the recipient); or (b) an employee or agent of a person mentioned in paragraph (a). Examples of delivery person for subsection (1) 1 A hospital employee. 2 An employee of a courier service. (2) The delivery person is authorised to: (a) possess the Scheduled substance for transporting and delivering it to the recipient in accordance with the delivery person's engagement by the authorised supplier; and (b) supply the substance to the recipient or recipient's employee or agent. Example of agent for subsection (2)(b) The guardian of a child for a substance supplied for administering to the child on a prescription issued by an authorised prescriber. (3) In this section: authorised supplier, for a Scheduled substance, means: (a) a person authorised to supply the substance under: (i) Part 2.3 or a regulation; or -- 62 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 1 Authorised prescribers Subdivision 1 Schedule 4 substances Medicines, Poisons and Therapeutic Goods Act 2012 47 (ii) an Act of the Commonwealth, a State or another Territory; or (b) the holder of an authority authorised to supply the substance. 80 Possessing Scheduled substances for destruction (1) This section applies to a waste disposer who is engaged by a person authorised under this Act to possess a Scheduled substance (the authorised person) to destroy the substance. (2) The waste disposer is authorised to possess the Scheduled substance for its destruction in accordance with the waste disposer's engagement by the authorised person. (3) However, the authorisation to possess the Scheduled substance has effect only for as long as is reasonably practicable for the waste disposer to destroy it after receiving it. (4) In this section: waste disposer means the holder of a licence under the Waste Management and Pollution Control Act 1998 for disposing of a Scheduled substance that is a listed waste under that Act. Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 1 Authorised prescribers Subdivision 1 Schedule 4 substances 81 Unrestricted Schedule 4 substance (1) A person must not issue a prescription for the supply of an unrestricted Schedule 4 substance unless: (a) the person: (i) is a dentist, doctor, endorsed midwife, nurse practitioner, optometrist or podiatrist or another health practitioner prescribed by regulation; and (ii) issues the prescription in the course of practising the person's health profession; or (b) the person: (i) is a veterinarian; and -- 63 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 1 Authorised prescribers Subdivision 2 Schedule 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 48 (ii) issues the prescription in the course of providing veterinary services in the Territory for the treatment of animals. Maximum penalty: 50 penalty units. (2) An offence against subsection (1) is an offence of strict liability. 82 Restricted Schedule 4 substance (1) A person must not issue a prescription for the supply of a restricted Schedule 4 substance unless: (a) the person: (i) is an authorised health practitioner; and (ii) issues the prescription in the course of practising the person's health profession in accordance with the conditions stated in the declaration of the substance as a restricted Schedule 4 substance; or (b) the person: (i) is a veterinarian; and (ii) issues the prescription in the course of providing veterinary services in the Territory for the treatment of animals. Maximum penalty: 100 penalty units. (2) An offence against subsection (1) is an offence of strict liability. Subdivision 2 Schedule 8 substances 83 Unrestricted Schedule 8 substance – general (1) A person must not issue a prescription for the supply of an unrestricted Schedule 8 substance unless: (a) the person: (i) is a dentist, doctor, endorsed midwife or nurse practitioner, podiatrist or another health practitioner prescribed by regulation; and (ii) issues the prescription in the course of practising the person's health profession; or -- 64 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 1 Authorised prescribers Subdivision 2 Schedule 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 49 (b) the person: (i) is a veterinarian; and (ii) issues the prescription in the course of providing veterinary services in the Territory for the treatment of animals. Maximum penalty: 100 penalty units. (2) An offence against subsection (1) is an offence of strict liability. 84 Unrestricted Schedule 8 substance – prohibited circumstances (1) A person must not issue a prescription for the supply of an unrestricted Schedule 8 substance in a prohibited circumstance mentioned in subsection (2) unless the person: (a) is an authorised health practitioner; and (b) issues the prescription: (i) under a Schedule 8 authorisation or Schedule 8 exemption; and (ii) in the course of practising the health practitioner's health profession. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Each of the following is a prohibited circumstance for issuing the prescription: (b) for treating a person's addiction to a substance; (c) for another purpose prescribed by regulation. Note for section 84 Section 139(1) provides that the CHO may, on application, authorise the supply, administration or the issue of a prescription for the supply of an unrestricted Schedule 8 substance in a prohibited circumstance. 85 Restricted Schedule 8 substance (1) A person must not issue a prescription for the supply of a restricted Schedule 8 substance unless: (a) the person: (i) is an authorised health practitioner; and -- 65 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 1 Authorised prescribers Subdivision 3 Additional qualifications for health practitioners under Health Practitioner Regulation National Law Medicines, Poisons and Therapeutic Goods Act 2012 50 (ii) issues the prescription in the course of practising the person's health profession under a Schedule 8 authorisation, or Schedule 8 exemption, for an authorised purpose; or (b) the person: (i) is a veterinarian; and (ii) issues the prescription in the course of providing veterinary services in the Territory for the treatment of animals. Maximum penalty: 100 penalty units. Note for subsection (1)(a) Under section 139(1)(c), a Schedule 8 authorisation for the issue of a prescription for the supply of a restricted Schedule 8 substance may be issued only to an authorised health practitioner for administration for an authorised purpose. In addition, under section 245, the CHO may issue a Schedule 8 exemption to an authorised health practitioner for the issue of a prescription for the supply of a restricted Schedule 8 substance for administration for an authorised purpose. (2) An offence against subsection (1) is an offence of strict liability. Subdivision 3 Additional qualifications for health practitioners under Health Practitioner Regulation National Law 86 Endorsement on health practitioner's registration for additional qualifications (1) This section applies to a health practitioner whose registration under the Health Practitioner Regulation National Law is endorsed as qualified to issue a prescription for the supply of a Scheduled substance (the endorsed qualification) in addition to an authorisation under Subdivision 1 or 2. Note for subsection (1) Part 7, Division 3 of the Health Practitioner Regulation National Law deals with the endorsement of registration under the Law. (2) The health practitioner may, in the course of practising in the health practitioner's health profession, issue a prescription for the supply of the Scheduled substance in accordance with the endorsed qualification. -- 66 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 2 Issue of prescriptions Medicines, Poisons and Therapeutic Goods Act 2012 51 (3) The health practitioner's authorisation under subsection (2) is subject to the conditions or other restrictions prescribed by regulation. Note for section 86 A health practitioner may also issue a prescription for a Schedule 3 substance, the cost of which is subsidised under the Australian Government's Pharmaceutical Benefits Scheme. Division 2 Issue of prescriptions 87 Requirements for prescription (1) An authorised prescriber must not issue a prescription for a Scheduled substance unless the issue of the prescription complies with: (a) the requirements prescribed by regulation; and (b) for a Schedule 8 substance or restricted Schedule 4 substance – the requirements prescribed by a code of practice. Maximum penalty: 100 penalty units. (2) An offence against subsection (1) is an offence of strict liability. 88 Duration of prescription A prescription issued under this Part for the supply of a Scheduled substance remains in force for the following period from the date it is issued: (a) if it is for supplying a Schedule 8 substance – 6 months or, if a shorter period is prescribed by a code of practice, the shorter period; (b) if it is for supplying another substance – 12 months. 89 Issuing prescription to patient (1) An authorised prescriber commits an offence if the prescriber: (a) issues a prescription for the supply of a Schedule 4 or 8 substance for administering to a person (the patient) for the patient's therapeutic use or treating a medical condition of the patient; and -- 67 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 2 Issue of prescriptions Medicines, Poisons and Therapeutic Goods Act 2012 52 (b) gives the prescription to a person (the recipient) other than: (i) the patient; or (ii) a carer of the patient; or (iii) a guardian of the patient; or (iv) a prescribed person. Maximum penalty: 100 penalty units. (2) Subsection (1) does not apply if: (a) the patient is the partner of the recipient; and (b) the substance is a Schedule 4 substance for treating the partner for the medical condition of chlamydia; and (c) the prescribed conditions apply to the issue of the prescription. (3) In addition, the authorised prescriber is not civilly liable in relation to the issue of the prescription. (4) Without limiting subsection (3), issuing and giving the prescription does not constitute a breach of professional etiquette or ethics or a departure from accepted standards of professional conduct. (5) In this section: carer, see section 5 of the Carer's Recognition Act 2006. partner, of a person, includes: (a) the person's spouse; and (b) the person's de facto partner; and (c) someone with whom the person is in a sexual relationship. prescribed means prescribed by regulation. 90 No self-prescription of Schedule 8 or restricted Schedule 4 substances An authorised prescriber must not issue to himself or herself a prescription for the supply of a Schedule 8 substance or restricted Schedule 4 substance. Maximum penalty: 200 penalty units or imprisonment for 2 years. -- 68 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.4 Prescriptions and orders for Schedule 4 and 8 substances Division 3 Orders for administering and supplying Schedule 4 and 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 53 91 Quantity of Schedule 8 substance authorised by prescription (1) An authorised prescriber must not issue a prescription for the supply of a Schedule 8 substance for more than: (a) 3 months supply of the substance administered at the daily dose recommended by the authorised prescriber; or (b) if a greater quantity is prescribed by a code that applies to the issue of the prescription – that quantity. Maximum penalty: 100 penalty units. (2) An offence against subsection (1) is an offence of strict liability. Division 3 Orders for administering and supplying Schedule 4 and 8 substances 92 Authorised prescriber may authorise administration and supply by order (1) An authorised prescriber for a Scheduled substance may: (a) by written or oral order (an administration order), authorise the administration of the substance by an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist to: (i) a patient of a hospital; or (ii) a resident at a residential facility; or (iii) a person receiving medical treatment at a declared place; or (iv) a person receiving palliative care at the person's residence in a circumstance prescribed by regulation; or (b) by written order (a supply order), authorise the supply of the substance by a pharmacist to: (i) a person on the person's discharge as a patient of a hospital; or (ii) the nurse employed at a residential facility for administration to a resident at the facility; or (iii) the person in charge of a declared place. -- 69 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.5 Special provisions about supplies of Schedule 4 and 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 54 (2) An administration order or supply order must comply with the requirements prescribed by regulation. Note for section 92 An administration order or supply order may be issued electronically in accordance with the Electronic Transactions (Northern Territory) Act 2000. Part 2.5 Special provisions about supplies of Schedule 4 and 8 substances 93 Supply of Schedule 4 and 8 substances on prescription (1) A pharmacist who supplies a Schedule 4 or 8 substance on a prescription must write the date of the supply on the prescription. Maximum penalty: 20 penalty units. (2) A pharmacist must not supply a Schedule 4 or 8 substance on a prescription that is not in force when the substance is supplied. Maximum penalty: 50 penalty units. (3) An offence against subsection (1) or (2) is an offence of strict liability. (4) It is a defence to a prosecution for an offence against subsection (1) or (2) if the defendant establishes a reasonable excuse. Note for section 93 In some circumstances, a pharmacist may supply a Schedule 4 or 8 substance without a prescription under sections 59 to 61. 94 Repeat supply of Schedule 8 substance (1) A pharmacist commits an offence if: (a) an authorised prescriber issues a repeat prescription for the supply of a Schedule 8 substance; and (b) the pharmacist supplies the substance within the minimum repeat interval for the prescription. Maximum penalty: 100 penalty units or imprisonment for 12 months. (2) Subsection (1) does not apply if the pharmacist is satisfied: (a) the previous supply of the substance was lost, stolen or destroyed; or -- 70 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.5 Special provisions about supplies of Schedule 4 and 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 55 (b) the supply is urgently needed to treat the person to whom the substance is supplied; or (c) other circumstances prescribed by a code of practice apply to the supply. 95 Health practitioner to ensure self-administration of some supplied Schedule 8 substances (1) This section applies to a health practitioner: (a) supplying a prescribed Schedule 8 substance under a Schedule 8 authorisation or Schedule 8 exemption; or (b) a health practitioner who is a pharmacist supplying a prescribed Schedule 8 substance on a prescription issued by an authorised prescriber. (2) The health practitioner must ensure the person to whom the substance is supplied self-administers the substance in the health practitioner's presence. Maximum penalty: 50 penalty units. (3) An offence against subsection (2) is an offence of strict liability. (4) Subsection (2) does not apply if, under a code of practice, takeaway doses of the substance are authorised for the person. (5) It is a defence to a prosecution for an offence against subsection (2) if the defendant establishes a reasonable excuse. (6) In this section: prescribed Schedule 8 substance means a Schedule 8 substance prescribed by a code of practice for this section. 96 Pharmacist to give CHO prescription for supply of Schedule 8 substance (1) A pharmacist who supplies a Schedule 8 substance or restricted Schedule 4 substance on a prescription must, within 7 days after the supply, give the CHO: (a) if the prescription is a repeat prescription that authorises supply on a later occasion – a copy of the prescription; or (b) otherwise – the prescription on which the pharmacist supplied the substance. Maximum penalty: 50 penalty units. -- 71 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.6 Special provisions about dealing with Scheduled substances in hospitals, residential facilities and declared places Medicines, Poisons and Therapeutic Goods Act 2012 56 (1A) Subsection (1) does not apply in relation to the supply of a monitored medicine for administration to a person. Note for subsection (1A) Section 243E(1)(b) requires information to be given by a pharmacist in relation to the supply of a monitored medicine for administration to a person. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the defendant establishes a reasonable excuse. 97 Obligations of authorised prescriber and pharmacist for supply made without prescription in emergency (1) This section applies if, under section 61, a pharmacist supplies a Schedule 4 or 8 substance to a person at the request of an authorised prescriber. (2) The authorised prescriber must give the pharmacist a prescription for the supply within 7 days after making the request. Maximum penalty: 20 penalty units. (3) If the pharmacist does not receive a prescription for the supply of the substance on the request within 7 days after the supply, the pharmacist must give a written report about the supply to the CHO. Maximum penalty: 20 penalty units. (4) An offence against subsection (2) or (3) is an offence of strict liability. (5) It is a defence to a prosecution for an offence against subsection (2) or (3) if the defendant establishes a reasonable excuse. Part 2.6 Special provisions about dealing with Scheduled substances in hospitals, residential facilities and declared places 98 Storage at hospital (1) The manager of a hospital must: (a) ensure all Scheduled substances received at the hospital are stored in an area and in a way to prevent unauthorised access to them; and -- 72 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.6 Special provisions about dealing with Scheduled substances in hospitals, residential facilities and declared places Medicines, Poisons and Therapeutic Goods Act 2012 57 (b) take reasonable measures to prevent unauthorised access at any time to the substances. Maximum penalty: 100 penalty units. (2) An offence against subsection (1) is an offence of strict liability. 99 Administering Schedule 3, 4 or 8 substance at hospital, residential facility or declared place (1) This section applies if: (a) a health practitioner is practising in the health practitioner's health profession at a hospital, residential facility or declared place; and (b) in the course of practising the health profession, the health practitioner: (i) is supplied a Schedule 3 substance; or (ii) is supplied a Schedule 4 or 8 substance on a prescription or supply order of an authorised prescriber for the substance; and (c) the substance is supplied for administering to a patient of the hospital, resident at the residential facility or person receiving medical treatment at the declared place (the relevant patient). (2) The health practitioner commits an offence if the health practitioner: (a) knows the supplied substance is a Schedule 3, 4 or 8 substance; and (b) administers the substance to the relevant patient; and (c) does not administer the substance in accordance with the instructions of the authorised prescriber. Maximum penalty: 100 penalty units. (3) The health practitioner commits an offence if the health practitioner: (a) knows the supplied substance is a Schedule 3, 4 or 8 substance; and (b) administers the substance to a person; and -- 73 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.6 Special provisions about dealing with Scheduled substances in hospitals, residential facilities and declared places Medicines, Poisons and Therapeutic Goods Act 2012 58 (c) knows the person is not the relevant patient. Maximum penalty: 200 penalty units. 100 Administration or supply of Schedule 8 substance to be witnessed (1) Subject to subsections (3) and (4), a health practitioner must not administer or supply a Schedule 8 substance to a relevant patient unless a person other than the practitioner or the patient witnesses the administration or supply of the substance. (2) Subject to subsections (3) and (4), if a health practitioner administers or supplies a Schedule 8 substance to a relevant patient and the administration or supply of the substance is witnessed by another person, the health practitioner must record the name of at least one person who witnessed the administration or supply of the substance in the record prescribed by regulation (the prescribed record). (3) Subsections (1) and (2) do not apply to a health practitioner if: (a) the health practitioner is an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist (the practitioner); and (b) another person is not reasonably available to witness the practitioner administer or supply the Schedule 8 substance to the relevant patient because of: (i) the remote location of the place where the substance is administered or supplied; or (ii) other special circumstances; and (c) the practitioner records the reason why the administration or supply of the substance was not witnessed in the relevant patient's clinical record. (4) Subsection (1) and (2) do not apply to a health practitioner if: (a) the health practitioner is a pharmacist; and (b) the Schedule 8 substance that is administered or supplied to the relevant patient by the pharmacist is a restricted Schedule 8 substance; and -- 74 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.6 Special provisions about dealing with Scheduled substances in hospitals, residential facilities and declared places Medicines, Poisons and Therapeutic Goods Act 2012 59 (c) the relevant patient is taking part in a pharmacotherapy program conducted at the hospital, residential facility or declared place. (5) A health practitioner commits an offence if: (a) the health practitioner administers or supplies a Schedule 8 substance to a relevant patient; and (b) the administration or supply of the substance is required to be witnessed under subsection (1); and (c) the administration or supply of the substance is not witnessed by a person other than the health practitioner or the relevant patient. Maximum penalty: 20 penalty units. (6) A health practitioner commits an offence if: (a) the health practitioner administers or supplies a Schedule 8 substance to a relevant patient; and (b) the administration or supply of the substance is witnessed by a person other than the health practitioner or the relevant patient; and (c) the health practitioner is required to record the name of at least one of the persons who witnessed the administration or supply of the substance in the prescribed record under subsection (2); and (d) the health practitioner fails to record the name of at least one of the persons who witnessed the administration or supply of the substance in the prescribed record. Maximum penalty: 20 penalty units. (7) An offence against subsection (5) or (6) is an offence of strict liability. (8) In this section: relevant patient means a person who is: (a) a patient of a hospital; or (b) a resident of a residential facility; or (c) receiving medical treatment at a declared place. -- 75 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.7 Other requirements for Scheduled substances Division 1 Packaging and labelling Medicines, Poisons and Therapeutic Goods Act 2012 60 Part 2.7 Other requirements for Scheduled substances Division 1 Packaging and labelling 101 Packaging supplied Scheduled substances (1) A person commits an offence if: (a) the person is authorised under this Act to supply a Scheduled substance to another person; and (b) the person supplies the substance to another person; and (c) the substance is not packaged as prescribed by regulation. Maximum penalty: 100 penalty units or imprisonment for 12 months. (2) Subsection (1) does not apply if the substance is supplied for immediately administering to a person. 102 Labelling supplied Scheduled substances (1) A person commits an offence if: (a) the person is authorised under this Act to supply a Scheduled substance to another person; and (b) the person supplies the substance to another person; and (c) the container of the substance is not labelled as prescribed by regulation. Maximum penalty: 100 penalty units or imprisonment for 12 months. (2) Subsection (1) does not apply if the substance is supplied for immediately administering to a person. 103 Permanently marked containers – use for other Scheduled substances (1) A person commits an offence if: (a) the person uses a container for storing a Scheduled substance; and -- 76 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.7 Other requirements for Scheduled substances Division 1 Packaging and labelling Medicines, Poisons and Therapeutic Goods Act 2012 61 (b) the container is permanently marked with the name of a different Scheduled substance. Maximum penalty: 50 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the defendant establishes a reasonable excuse. 104 Scheduled substance container not to be used for human-use substance (1) A person commits an offence if: (a) the person supplies a human-use substance in a container; and (b) the container is of a kind of container prescribed by regulation that has been used for storing a Scheduled substance. Maximum penalty: 50 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the defendant establishes a reasonable excuse. (4) In this section: human-use substance means any of the following substances: (a) food; (b) a drink; (c) a condiment. -- 77 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.7 Other requirements for Scheduled substances Division 2 Vending machine supplies Medicines, Poisons and Therapeutic Goods Act 2012 62 Division 2 Vending machine supplies 105 Definitions In this Division: manufacturer's pack, of an unscheduled substance, means a primary pack of the substance that has been packaged and labelled by the substance's manufacturer in compliance with the medicines and poisons standard. Note A primary pack is a pack in which a substance and its immediate container or immediate wrapper or measure pack are presented for sale or supply (see the medicines and poisons standard). unscheduled substance means a substance mentioned in Schedule 2, 3, 4 or 8 to the medicines and poisons standard if none of the Schedules apply to the substance because of an exception in the standard. Example Aspirin is mentioned in several Schedules of the medicines and poisons standard but in small packages is an unscheduled substance. vending machine means a machine or device from which a Scheduled substance can be obtained, including by one or more of the following: (a) electronic funds transfer; (b) inserting money, a token or something else. Examples of other things for paragraph (b) 1 A credit card. 2 A debit card. 3 A key. 106 Vending machine supplies of unscheduled substances (1) A person commits an offence if: (a) the person is the occupier of premises; and (b) a vending machine is installed on the premises; and -- 78 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.7 Other requirements for Scheduled substances Division 4 Paints Medicines, Poisons and Therapeutic Goods Act 2012 63 (c) the vending machine is used, or available for use, for supplying an unscheduled substance. Maximum penalty: 100 penalty units or imprisonment for 12 months. (2) Strict liability applies to subsection (1)(a) and (b). (3) Subsection (1) does not apply if the vending machine was placed on the premises without the occupier's consent. (4) In addition, subsection (1) does not apply if: (a) the unscheduled substance is supplied in a manufacturer's pack containing not more than 2 adult doses of the substance; and (b) the substance was packed in the manufacturer's pack by the manufacturer of the substance; and (c) the vending machine is presented and located in a way that makes unsupervised access by children unlikely. Division 3 Methylated spirit 107 Drinking methylated spirit (1) A person must not drink a methylated spirit. Maximum penalty: 20 penalty units. (2) An offence against subsection (1) is an offence of strict liability. 108 Supplying methylated spirit for drinking A person must not supply a methylated spirit to another person for drinking by the other person or someone else. Maximum penalty: 100 penalty units or imprisonment for 12 months. Division 4 Paints 110 Manufacture, supply and use of first, second and third schedule paints (1) A person commits an offence if the person manufactures, supplies or uses a first schedule paint as prescribed by regulation. Maximum penalty: 40 penalty units. -- 79 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.7 Other requirements for Scheduled substances Division 4 Paints Medicines, Poisons and Therapeutic Goods Act 2012 64 (2) A person commits an offence if the person manufactures, supplies or uses a second schedule paint as prescribed by regulation. Maximum penalty: 50 penalty units. (3) A person commits an offence if the person manufactures, supplies or uses a third schedule paint. Maximum penalty: 100 penalty units or imprisonment for 12 months. Note for section 110 Paragraph 6 of Part 1 of the medicines and poisons standard defines the paints to which this section applies. 111 Manufacture, supply and use of paints for toys (1) A person commits an offence if: (a) the person manufactures a paint with the intention the paint be applied to toys; and (b) the paint does not comply with the requirements prescribed by regulation. Maximum penalty: 100 penalty units or imprisonment for 12 months. (2) A person commits an offence if: (a) the person supplies a paint; and (b) knows the paint is to be applied to toys; and (c) the paint does not comply with the requirements prescribed by regulation. Maximum penalty: 100 penalty units or imprisonment for 12 months. (3) A person commits an offence if: (a) the person applies a paint to toys; and (b) the paint does not comply with the requirements prescribed by regulation. Maximum penalty: 200 penalty units or imprisonment for 2 years. -- 80 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.7 Other requirements for Scheduled substances Division 4A Advertising use of pesticides Medicines, Poisons and Therapeutic Goods Act 2012 65 112 Manufacture, supply and use of paints containing pesticides A person commits an offence if: (a) the person manufactures, supplies or uses a paint containing a pesticide; and (b) the pesticide is not prescribed by regulation. Maximum penalty: 100 penalty units or imprisonment for 12 months. Division 4A Advertising use of pesticides 112A Definition In this Division: pest authorisation means: (a) a pest management technician licence; or (b) a licence granted under Part 5, Division 2 of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004; or (c) an S7 authorisation issued under the Agricultural and Veterinary Chemicals (Control of Use) Regulations 2005. 112B Representation by unauthorised person (1) A person commits an offence if the person: (a) represents, by any means, that the person carries out pest control operations involving the use of a pesticide for fee or reward; and (b) is not authorised under a pest authorisation to use the pesticide. Maximum penalty: 100 penalty units. (2) An offence against subsection (1) is an offence of strict liability. 112C Advertisement to include authorisation number (1) An advertisement for pest control operations that are offered by a business and involve the use of a pesticide must state: (a) if the owner of the business holds a pest authorisation – the number of that authorisation; or -- 81 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.7 Other requirements for Scheduled substances Division 5 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 66 (b) otherwise – the number of the pest authorisation held by at least one person who is employed or contracted by the owner to carry out pest control operations for the business. (2) A person commits an offence if: (a) the person: (i) places or distributes an advertisement for pest control operations that are offered by a business and involve the use of a pesticide; or (ii) authorises another person to place or distribute an advertisement mentioned in subparagraph (i); and (b) the advertisement does not state the information required under subsection (1). Maximum penalty: 100 penalty units. (3) An offence against subsection (2) is an offence of strict liability. (4) In this section: advertisement means every form of advertisement or notice, however displayed, and whether or not displayed to the public. Examples for definition advertisement 1 A post on a social media platform. 2 A flyer on a noticeboard. Division 5 Miscellaneous matters 113 Advertising some Scheduled substances (1) A person commits an offence if: (a) the person publishes an advertisement; and (b) the advertisement promotes or encourages the use of a prescribed substance. Maximum penalty: 100 penalty units or imprisonment for 12 months. (2) A person commits an offence if: (a) the person publishes an advertisement; and -- 82 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.7 Other requirements for Scheduled substances Division 5 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 67 (b) the advertisement indicates someone is willing or authorised under this Act to supply a prescribed substance. Maximum penalty: 100 penalty units or imprisonment for 12 months. (3) Subsections (1) and (2) do not apply to: (a) an advertisement for a prescribed substance in a publication published primarily for health practitioners or veterinarians; or (b) an advertisement prescribed by regulation. (4) In this section: advertisement, for a prescribed substance, means writing, sound or a picture, symbol, light or other visible device, object or sign (or a combination of 2 or more of them) that a reasonable person would consider publicises, or otherwise promotes, the purchase or use of the substance. prescribed substance means: (a) a Schedule 3 substance other than a Schedule 3 substance to which Appendix H to the medicines and poisons standard applies; or (b) a Schedule 4, 8 or 9 substance. 114 No self-administration of Schedule 8 or restricted Schedule 4 substances (1) A person who is authorised under this Act to supply a Schedule 8 substance or restricted Schedule 4 substance must not self-administer the substance. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Subsection (1) does not apply if the substance has been supplied to the person for self-administration by someone else who is authorised under this Act to do so (an authorised person). -- 83 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.8 CHO prohibitions Medicines, Poisons and Therapeutic Goods Act 2012 68 (3) In addition, it is a defence to a prosecution for an offence against subsection (1) if the defendant proves: (a) the defendant: (i) self-administered the substance for a genuine therapeutic use in an emergency and had no access to an authorised person to administer the substance; and (ii) gives notice of the administration in the approved form to the CHO within 7 days after the administration; or (b) the defendant self-administered the substance under another circumstance prescribed by regulation. Part 2.8 CHO prohibitions 115 Temporary prohibition on dealing with substance (1) This section applies if the CHO is satisfied, because of urgent circumstances, it is necessary to immediately prohibit dealing with a substance to promote or protect public health and safety. (2) The CHO may, by Gazette notice, prohibit the dealing subject to the conditions the CHO considers appropriate. (3) The notice must state the particulars of the prohibition, including the following: (a) the substance; (b) the kind of dealing prohibited; (c) the reasons for the prohibition; (d) the conditions of the prohibition. (4) A person must not engage in conduct that results in a contravention of the prohibition. Maximum penalty: 200 penalty units or imprisonment for 2 years. (5) The notice has effect despite another provision of this Act. (6) The notice ceases to have effect on the earlier of the following: (a) the date stated in it; (b) 3 months after it commences. -- 84 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.8 CHO prohibitions Medicines, Poisons and Therapeutic Goods Act 2012 69 (7) In this section: dealing with, for a substance, means to do any of the things mentioned in section 17(a) to (j) with the substance. substance means a substance mentioned in a Schedule or Appendix to the medicines and poisons standard (whether or not the standard applies to the substance). Note for section 115 Because clause 1(2) of the medicines and poisons standard applies to the interpretation of this Act under section 15(2), a substance includes: (a) a substance prepared from natural sources or artificially; and (b) every salt, active principle or derivative of the substance; and (c) a preparation or admixture containing any proportion of the substance. 116 Prohibition on health practitioner or veterinarian dealing with Schedule 8 substance (1) If the CHO considers a health practitioner or veterinarian should be prohibited from dealing with Schedule 8 substances, or a particular Schedule 8 substance, the CHO may give the health practitioner or veterinarian written notice stating: (a) the particulars of the proposed prohibition, including its duration; and (b) the reasons for the proposed prohibition; and (c) the health practitioner or veterinarian may, within the period stated in the notice, make written representations to the CHO objecting to the proposed prohibition. (2) After the end of the period stated in the notice, the CHO may, by written notice (the prohibition notice), prohibit the health practitioner or veterinarian from dealing with Schedule 8 substances, or a stated Schedule 8 substance, as stated in the notice. (3) The prohibition notice may be subject to stated conditions. Example for subsection (3) The prohibition may state a place from where a pharmacist may store a substance to enable the pharmacist to supply it on a prescription issued by an authorised prescriber. (4) In deciding whether to give the prohibition notice, the CHO must have regard to written submissions made by the health practitioner or veterinarian before the end of the period. -- 85 of 187 -- Chapter 2 Dealing with Scheduled substances Part 2.8 CHO prohibitions Medicines, Poisons and Therapeutic Goods Act 2012 70 (5) The prohibition notice must include an information notice for the decision. (6) The health practitioner or veterinarian must not engage in conduct that results in a contravention of the prohibition notice. Maximum penalty: 200 penalty units or imprisonment for 2 years. (7) The notice has effect despite another provision of this Act. -- 86 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 1 Interpretation Medicines, Poisons and Therapeutic Goods Act 2012 71 Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 1 Interpretation 117 Types of authorities Each of the following is an authority issued by the CHO: (a) a manufacturer certificate of registration; (b) a wholesaler certificate of registration; (ba) a Schedule 4 supplier certificate of registration; (c) a retailer licence; (ca) a Schedule 3 authorisation; (d) a Schedule 4 authorisation; (e) a Schedule 7 authorisation; (f) a pest management technician licence; (g) a Schedule 8 authorisation; (h) a prohibited substance authorisation; (i) a research authorisation; (j) a medical kit authorisation. 118 Suitability of authority holder – individuals (1) In deciding whether an individual (other than a health practitioner) is a suitable person to hold an authority, the CHO must have regard to the following: (a) the knowledge, experience and qualifications of the individual in relation to the Scheduled substances to which the authority relates; (b) the dealings with Scheduled substances to which the authority relates and the purpose of the dealings; (c) another matter prescribed by regulation. -- 87 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 1 Interpretation Medicines, Poisons and Therapeutic Goods Act 2012 72 (2) However, an individual is not a suitable person to hold an authority if: (a) the individual has been convicted or found guilty of any of the following in the 5-year period before the day the application for the authority is made: (i) an offence against this Act; (ii) an offence in Australia or elsewhere in relation to a Scheduled substance; or (b) the individual at any time in the 5-year period before the day the application for the authority is made: (i) was an undischarged bankrupt; or (ii) executed a personal insolvency agreement; or (c) at any time in the 5-year period before the day the application for the authority is made, the individual was involved in the management of a body corporate when: (i) the body corporate became the subject of a winding-up order; or (ii) an administrator was appointed for the body corporate; or (d) a circumstance prescribed by regulation applies in relation to the individual. (3) Despite subsection (2), the CHO may decide an individual is a suitable person to hold an authority if satisfied: (a) the individual's dealings with Scheduled substances authorised, or to be authorised, by the authority would not be inconsistent with the objects of this Act if the CHO decided that the individual is a suitable person; and (b) it is otherwise in the public interest that the individual be treated as a suitable person. 119 Suitability of authority holder – bodies corporate (1) A body corporate is a suitable person for an authority if: (a) each executive officer of the body corporate is a suitable person to hold the authority; and -- 88 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 2 Authorised activities under authorities Medicines, Poisons and Therapeutic Goods Act 2012 73 (b) the body corporate is not the subject of a winding-up order, and has not been the subject of a winding-up order in the 5-year period before the day the application for the authority is made; and (c) an administrator has not been appointed for the body corporate in the 5-year period before the day the application for the authority is made. (2) However, if a body corporate is not a suitable person for an authority under subsection (1), the CHO may decide the body corporate is a suitable person to hold an authority if satisfied: (a) the body corporate's dealings with Scheduled substances to which the authority relates would not be inconsistent with the objects of this Act if the CHO decided the body corporate is a suitable person; and (b) it is otherwise in the public interest that the body corporate be treated as a suitable person. 120 Suitability of nominated person – certificate of registration An individual is a suitable person to be the nominated person for a certificate of registration if the individual: (a) is a suitable person to hold the authority; and (b) the CHO is satisfied the person is suitable to have control of the business activities or services to be carried out under the authority. Division 2 Authorised activities under authorities 121 Manufacturer certificate of registration A manufacturer certificate of registration, for a place, is an authority that authorises its holder to: (a) manufacture the Scheduled substances stated in the certificate at the place; and (b) supply the manufactured substances from the place in the course of carrying out business activities for the manufacture of the substances; and -- 89 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 2 Authorised activities under authorities Medicines, Poisons and Therapeutic Goods Act 2012 74 (c) possess the substances for a purpose mentioned in paragraph (a) or (b). Note for section 121 A manufacturer certificate of registration may authorise the manufacture, possession and supply of a dangerous drug that would otherwise be unlawful under Part II, Division 1 of the Misuse of Drugs Act 1990. 122 Wholesaler certificate of registration A wholesaler certificate of registration, for a place, is an authority that authorises its holder to: (a) supply the Scheduled substances stated in the certificate from the place in the course of carrying out business activities for the sale of the substances by wholesale; and (b) possess the substances for a purpose mentioned in paragraph (a). 122A Schedule 4 supplier certificate of registration A Schedule 4 supplier certificate of registration, for a place, is an authority that authorises its holder: (a) to supply, but not to sell, the Schedule 4 substances stated in the certificate from the place in the course of carrying out the service of distributing the substances to health practitioners or health services; and (b) to possess the substances for a purpose mentioned in paragraph (a). 123 Retailer licence A retailer licence, for a place, is an authority that authorises the licensee to: (a) supply the Schedule 2 and 7 substances stated in it from the place in the course of carrying out business activities for the retail sale of the substances; and (b) possess the substances for a purpose mentioned in paragraph (a). Note for section 123 However, under section 145, the licensee is prohibited from supplying a Schedule 2 substance from the licensed place if it is located within 25 km, by the shortest practical route, of a pharmacy. -- 90 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 2 Authorised activities under authorities Medicines, Poisons and Therapeutic Goods Act 2012 75 123A Schedule 3 authorisation A Schedule 3 authorisation is an authority that authorises its holder, and the persons stated in it, to supply, but not to sell, the Schedule 3 substances stated in it. 124 Schedule 4 authorisation A Schedule 4 authorisation is an authority that authorises its holder, and the persons stated in it, to do one or more of the following in relation to the Schedule 4 substances stated in it: (a) administer the substances to animals (but not humans) for the purposes stated in it; (b) otherwise use the substances; (c) possess the substances for a purpose mentioned in paragraph (a) or (b). 125 Schedule 7 authorisation (1) A Schedule 7 authorisation is an authority that authorises its holder to use the Schedule 7 substances (other than a chemical product) stated in it. (2) In this section: chemical product, see section 4(1) of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004. Note for subsection (2) The Agricultural and Veterinary Chemicals (Control of Use) Act 2004 provides controls on the use of chemical products. The controls under that Act include, for example, obligations on pharmacists providing information to people about chemical products supplied to them on the prescription of a veterinarian, see section 34 of that Act. 126 Pest management technician licence A pest management technician licence is an authority that authorises the licensee to use the pesticides stated in it for carrying out pest control operations. Note for section 126 Depending on the knowledge, experience and qualifications of the licensee in the use of pesticides, the licence may be subject to conditions about the use of stated pesticides. For example, the licence may authorise use of a pesticide only under the direct supervision of a licensee with additional qualifications. -- 91 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 2 Authorised activities under authorities Medicines, Poisons and Therapeutic Goods Act 2012 76 127 Schedule 8 authorisation A Schedule 8 authorisation is an authority that authorises its holder to do one or more of the following in relation to the Schedule 8 substances stated in it: (a) supply the substances; (b) administer the substances to another person or to animals; (c) otherwise use the substances; (d) issue a prescription for the supply of the substances; (e) possess the substances for a purpose mentioned in paragraphs (a) to (d). Notes for section 127 1 A Schedule 8 authorisation may authorise the possession, supply or use of a dangerous drug that would otherwise be unlawful under Part II, Division 1 of the Misuse of Drugs Act 1990. 2 Also, see section 139 for restrictions applying in relation to the issue of Schedule 8 authorisations. 128 Prohibited substance authorisation (1) A prohibited substance authorisation issued to an authorised health practitioner (the authority holder) is an authority that authorises the authority holder, and another authorised health practitioner stated in it, to do one or more of the following in relation to the prohibited substance stated in it: (a) administer the substance to the person stated in it; (b) supply the substance to the person stated in it for the person to self-administer; (c) possess the substance for a purpose mentioned in paragraph (a) or (b). (2) If the authorisation authorises the supply of the substance to the person stated in it for self-administration, the authorisation also authorises the person to: (a) self-administer the substance; and (b) possess the substance to self-administer. -- 92 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.1 Preliminary matters Division 2 Authorised activities under authorities Medicines, Poisons and Therapeutic Goods Act 2012 77 (3) A prohibited substance authorisation issued to a veterinarian or other person prescribed by regulation is an authority that authorises its holder to do the following in relation to the substance: (a) administer the substance to animals; (b) possess the substance for the purpose mentioned in paragraph (a). Notes for section 128 1 A prohibited substance authorisation may authorise the possession, supply or use of a dangerous drug that would otherwise be unlawful under Part II, Division 1 of the Misuse of Drugs Act 1990. 2 Also, see section 140 for restrictions applying in relation to prohibited substance authorisations. 129 Research authorisation A research authorisation is an authority that authorises its holder to: (a) administer or supply, but not to sell, Schedule 3 substances to another person; or (b) do one or more of the following in relation to the Schedule 4, 7 and 8 substances, or prohibited substances, stated in it for medical or scientific research: (i) administer the substances to stated persons or to animals; (ii) otherwise use the substances; (iii) possess the substances for a purpose mentioned in subparagraph (i) or (ii). Notes for section 129 1 A research authorisation may authorise the possession, supply or use of a dangerous drug that would otherwise be unlawful under Part II, Division 1 of the Misuse of Drugs Act 1990. 2 Also, see section 141 for restrictions applying in relation to research authorisations. 130 Medical kit authorisation (1) A medical kit authorisation is an authority that authorises its holder, and the other persons stated in it, to: (a) administer or supply, but not to sell, Schedule 3 substances to another person; and -- 93 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 1 Making and consideration of application Medicines, Poisons and Therapeutic Goods Act 2012 78 (b) do one or more of the following in relation to the Schedule 4 substances stated in it: (i) supply the substances; (ii) self-administer the substances; (iii) administer the substances to another person; (iv) possess the substances for a purpose mentioned in subparagraphs (i) to (iii). (2) In addition, the authorisation may authorise its holder, and the other persons stated in it, to: (a) administer the Schedule 8 substances stated in it; and (b) possess the substances for that purpose. Part 3.2 Application process for authorities Division 1 Making and consideration of application 131 Making application An application for an authority must: (a) be made to the CHO in the approved form; and (b) be accompanied by sufficient documents and information to enable the CHO to decide the application; and (c) for an application for a certificate of registration – state the name of the individual to have control of the business activities or services to be carried out at the place (the nominated person). 132 CHO may require further information The CHO may, by written notice, require the applicant to give the CHO further documents or information, within the reasonable period stated in the notice, for considering and deciding the application. -- 94 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 1 Making and consideration of application Medicines, Poisons and Therapeutic Goods Act 2012 79 133 CHO to give application for Schedule 8 authorisation to Committee If the application is for a Schedule 8 authorisation for a restricted Schedule 8 substance, the CHO must give the application and all documents and information in support of it to the Committee for its advice. Note for section 133 Under section 139(5), the CHO may issue a Schedule 8 authorisation to the applicant without considering the Committee's advice if the circumstances prescribed by regulation apply. 134 Considering and deciding application (1) The CHO must consider the application and either issue, or refuse to issue, the authority sought. (2) The CHO must issue the authority if satisfied: (a) no restriction on the issue of the authority under Division 2, or prescribed by regulation, applies in relation to the application; and (b) the applicant can comply with this Act in relation to the Scheduled substances to which the application relates; and (c) the substances are to be stored in an area and in a way to prevent unauthorised access to them; and (d) if the application is for a certificate of registration – the proposed nominated person stated in the application is a suitable person; and (e) if the application is made by a person who is not a health practitioner – the applicant is a suitable person to hold the authority. Note about storage of Scheduled substances for subsection (2)(c) In addition, the CHO must be satisfied about security arrangements for some places where Scheduled substances are stored, see sections 135(b), 136(b), 136A(1)(b), 140(1)(f) and 141(1)(e). (3) The CHO must refuse to issue the authority if the CHO is not satisfied about the matters mentioned in subsection (2). -- 95 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 2 Restrictions on issue of authorities Medicines, Poisons and Therapeutic Goods Act 2012 80 (4) In addition, the CHO may refuse to issue a Schedule 7 authorisation or pest management technician licence if satisfied about the matter mentioned in section 172(4). Note for subsection (4) Under section 172(4)(a), the CHO may refuse to issue a Schedule 7 authorisation or pest management technician licence if satisfied a medical examination indicates the applicant's use or continued use of Schedule 7 substances or pesticides is a threat to the applicant's health. Division 2 Restrictions on issue of authorities 135 Certificate of registration The CHO may issue a certificate of registration only if satisfied, having regard to the nature of the business activities or services to be carried out and the Scheduled substances involved: (a) the place to which the application relates is suitable: (i) for a manufacturer certificate of registration – for manufacturing and storing the Scheduled substances; or (ii) for a wholesaler certificate of registration or Schedule 4 supplier certificate of registration – for storing the Scheduled substances; and (b) security arrangements for the place are adequate to prevent the unlawful use or removal of the substances from the place. 136 Retailer licence The CHO may issue a retailer licence only if satisfied: (a) the place to which the application relates: (i) is suitable for storing Scheduled substances for supply; and (ii) constitutes one retail outlet only; and (b) security arrangements for the place are adequate to prevent the unlawful use or removal of the substances from the place. -- 96 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 2 Restrictions on issue of authorities Medicines, Poisons and Therapeutic Goods Act 2012 81 136A Schedule 3 authorisation (1) The CHO may issue a Schedule 3 authorisation for a Schedule 3 substance only if satisfied that: (a) the applicant, and each person to be authorised under the authority to supply the substance, is competent to: (i) safely handle the substance; and (ii) give instructions for the safe use of the substance when supplying it; and (b) the security arrangements for the place where the substances are to be stored by the applicant are adequate to prevent the unlawful use or removal of the substances from the place. (2) In considering the matters referred to in subsection (1)(a), the CHO may have regard to: (a) the applicant's proposed policies or guidelines for supplying the substance; and (b) whether the applicant, and each person to be authorised under the authority to supply the substance, have any appropriate training, experience or qualifications for supplying the substance. 137 Schedule 4 authorisation The CHO may issue a Schedule 4 authorisation only if satisfied the intended use of a Schedule 4 substance is an authorised purpose. Note for section 137 For authorised purposes for Schedule 4 substances, see paragraph (a) of the definition authorised purpose in section 5. 138 Pest management technician licence The CHO may issue a pest management technician licence only to an individual. 139 Schedule 8 authorisation (1) The CHO may issue a Schedule 8 authorisation that authorises any of the following only if satisfied the applicant is an authorised health practitioner: (a) the supply or administration of an unrestricted Schedule 8 substance in a prohibited circumstance; -- 97 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 2 Restrictions on issue of authorities Medicines, Poisons and Therapeutic Goods Act 2012 82 (b) the supply or administration of a restricted Schedule 8 substance for an authorised purpose and possession of the substance for that purpose; (c) the issue of a prescription for the supply of: (i) an unrestricted Schedule 8 substance in a prohibited circumstance; or (ii) a restricted Schedule 8 substance for an authorised purpose. Note for subsection (1)(a) and (c)(i) For prohibited circumstances for the supply or administration, or the issue of a prescription for the supply, of an unrestricted Schedule 8 substance, see sections 48(2) and 84(2). Note for subsection (1)(b) and (c)(ii) For authorised purposes for restricted Schedule 8 substances, see paragraphs (b) and (c) of the definition authorised purpose in section 5. (2) In addition, the CHO may issue a Schedule 8 authorisation that authorises the supply of a restricted Schedule 8 substance to a person for self-administration for an authorised purpose only if satisfied: (a) it is not reasonably practicable in the circumstances for the substance to be administered by an authorised health practitioner; and (b) the person is competent to properly self-administer the substance. (3) Otherwise, the CHO may issue a Schedule 8 authorisation for a Schedule 8 substance only if satisfied the intended use of the substance is an authorised purpose. (4) The CHO must consider the Committee's advice before issuing a Schedule 8 authorisation mentioned in subsection (2). (5) However, if the circumstances prescribed by regulation apply, the CHO may issue a Schedule 8 authorisation mentioned in subsection (2) without considering the Committee's advice. 140 Prohibited substance authorisation (1) The CHO may issue a prohibited substance authorisation for a prohibited substance only in the circumstances mentioned in subsection (2) or (3). -- 98 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 2 Restrictions on issue of authorities Medicines, Poisons and Therapeutic Goods Act 2012 83 (2) The CHO may issue a prohibited substance authorisation for a prohibited substance if satisfied: (a) the applicant is an authorised health practitioner; and (b) a person is suffering an illness for which there is a therapeutic need for treatment with the substance; and (c) the substance is to be: (i) administered to the person by the applicant or another authorised health practitioner to treat the illness; or (ii) self-administered by the person to treat the illness; and (d) the administration of the substance is justified in the circumstances because the person is suffering from symptoms unresponsive to other available treatment; and (e) if the substance is to be self-administered: (i) it is not reasonably practicable in the circumstances for the substance to be administered by an authorised health practitioner; and (ii) the person is competent to properly self-administer the substance; and (f) security arrangements for the place where the substance is to be stored are adequate to prevent the unlawful use or removal of the substance from the place. (3) The CHO may issue a prohibited substance authorisation for a prohibited substance if satisfied: (a) the applicant is a veterinarian or other person prescribed by regulation; and (b) the substance is for use to sedate animals or for another use prescribed by regulation; and (c) security arrangements for the place where the substance is to be stored are adequate to prevent the unlawful use or removal of the substance from the place. -- 99 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 2 Restrictions on issue of authorities Medicines, Poisons and Therapeutic Goods Act 2012 84 141 Research authorisation (1) The CHO may issue a research authorisation for a Schedule 3, 4 or 8 substance, or a prohibited substance, for medical or scientific research only if satisfied: (a) the research has merit and is justified; and (b) the research is to be conducted or supervised by persons with experience, qualifications and competence that are appropriate for the research; and (c) the research is to be conducted using facilities and resources appropriate for the research; and (d) the research cannot be carried out without the use of the substance; and (e) security arrangements for the place where the research is to be conducted are adequate to prevent the unlawful use or removal of the substance from the place. (2) In deciding whether the research has merit and is justified, the CHO must take into account the following: (a) the scope and objectives of the research; (b) the potential benefits or predicted value to be gained by the research; (c) if the research involves participation by humans: (i) ethical considerations; and (ii) the risk of potential harm to the participants, their families and the community at large, including, for example, the kind of harm, the likelihood of the harm occurring and the severity of the harm; (d) if the research involves the use of animals: (i) ethical considerations; and (ii) the potential effects on the welfare of the animals. Note for section 141 Other legislation may apply to the medical or scientific research for which the application is made, for example, the National Health and Medical Research Council Act 1992 (Cth). Under that Act, guidelines are issued on matters relating to public health research and medical research. -- 100 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 3 Conditions of authorities Medicines, Poisons and Therapeutic Goods Act 2012 85 142 Medical kit authorisation The CHO may issue a medical kit authorisation for Scheduled substances only if satisfied: (a) the professional advice or personal attendance of a health practitioner is not always reasonably available before administering the substances; and (b) the applicant, and each person to be authorised under the authority to administer the substances, are competent to safely handle and administer the substances. Examples of circumstances for issue of medical kit authorisation 1 The applicant is the lessee of a pastoral or mining lease where the substances are to be kept to treat medical problems that may arise. 2 The substances are to be kept on an ocean-going boat to treat medical problems that may arise while at sea. 3 The substances are for use at a cyclone shelter to treat medical problems that may arise during an emergency. Division 3 Conditions of authorities 143 Conditions – general (1) An authority is subject to: (a) the conditions stated in this Division for the authority; and (b) the other conditions prescribed by: (i) regulation; or (ii) for a Schedule 8 substance or restricted Schedule 4 substance – a code of practice. Examples of conditions for subsection (1)(b) 1 The quantity, form and strength of a Scheduled substance authorised to be used under an authority. 2 A limit in relation to the persons: (a) to whom the Scheduled substance can be supplied or administered under the authority; and (b) for whom prescriptions can be issued under the authority. -- 101 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 3 Conditions of authorities Medicines, Poisons and Therapeutic Goods Act 2012 86 (2) In addition, the CHO may issue the authority subject to the reasonable conditions stated in it. Example of condition for subsection (2) A pest management technician licence may be subject to the condition that its holder may carry out pest control operations only under the direct supervision of another pest management technician licensee who is the holder's employer. (3) Without limiting subsection (2), conditions may be imposed about compliance with a stated code of practice applicable to activities under the authority. 144 Conditions – certificate of registration A certificate of registration for a Scheduled substance is subject to the following conditions: (a) its holder may supply the substance only to: (i) a health practitioner or veterinarian authorised under this Act to possess the substance; or (ii) the holder of an authority to possess the substance; or (iii) the person in charge of a declared place; or (iv) a person authorised to possess the substance under another law in force in the Territory; or (b) its holder must deal with the substance in accordance with the code of conduct, or other document, prescribed by regulation. 145 Conditions – retailer licence A retailer licence is subject to the condition that the licensee must not supply a Schedule 2 substance from the licensed place if it is located within 25 km, by the shortest practical route, of a pharmacy. 145A Conditions – Schedule 3 authorisation (1) A Schedule 3 authorisation is subject to the condition that an authorised person who supplies a Schedule 3 substance to another person under the authority must, at the time of the supply, give the person adequate instructions (written or oral) for the use of the substance. (2) The regulations may provide for matters relating to the content of the instructions that are required to be given in accordance with the condition imposed by subsection (1). -- 102 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.2 Application process for authorities Division 4 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 87 (3) In this section: authorised person means the holder of the Schedule 3 authorisation and any other person stated in the authority. 146 Conditions – Schedule 8 authorisation If a condition of a Schedule 8 authorisation for a restricted Schedule 8 substance is inconsistent with a provision in Appendix D to the medicines and poisons standard, the condition prevails to the extent of the inconsistency. 147 Contravention of condition The holder of an authority must not engage in conduct that results in a contravention of a condition of the authority. Maximum penalty: 100 penalty units or imprisonment for 12 months. Division 4 Miscellaneous matters 148 Duration of authority An authority remains in force for: (a) the period, not longer than 3 years, stated in it; or (b) if a longer period is prescribed by regulation – the period prescribed. 149 Form of authority An authority must: (a) be in the approved form; and (b) contain the information prescribed by regulation. 150 Notice of refusal to issue authority or impose conditions If the CHO refuses to issue an authority or issues an authority subject to stated conditions, the CHO must immediately give the applicant an information notice for the decision. 151 Failure to decide application The CHO is taken to have refused an application for an authority if the CHO does not decide the application within 30 days after: (a) the application is made; or -- 103 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.5 Variation of conditions of authorities Division 1 Interpretation Medicines, Poisons and Therapeutic Goods Act 2012 88 (b) if the CHO gives the applicant notice to give the CHO further documents or information – the end of the period stated in the notice for giving the document or information. Part 3.3 Renewal of licences and certificates of registration 152 Application for renewal (1) An application for the renewal of a certificate of registration or licence must be made by the holder of the authority. (2) Part 3.2 applies (with the necessary changes) to the application as if it were an application for an authority. 153 Authority continues until application decided If an application for the renewal of an authority is made at least 30 days before the authority ends, it continues in force until the application is decided. Part 3.4 Transfer of authorities 154 Transfer of certificate of registration (1) The holder of a certificate of registration may apply for the transfer of the certificate of registration. (2) Part 3.2 applies (with the necessary changes) to the application as if it were an application for a certificate of registration. 155 Other authorities not transferable An authority other than a certificate of registration is not transferable. Part 3.5 Variation of conditions of authorities Division 1 Interpretation 156 Definitions In this Part: condition, of an authority, means a condition of the authority imposed by the CHO under section 143(2). -- 104 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.5 Variation of conditions of authorities Division 2 Variation of conditions of authority on CHO's initiative Medicines, Poisons and Therapeutic Goods Act 2012 89 variation, of a condition of an authority, means: (a) amend an existing condition of the authority; or (b) impose a new condition of the authority; or (c) remove an existing condition of the authority. Division 2 Variation of conditions of authority on CHO's initiative 157 CHO may vary conditions to achieve object of Act (1) The CHO may decide to vary the conditions of an authority if: (a) the CHO becomes aware of information that, if it had been known when the authority was issued or renewed, the CHO would have imposed conditions or different conditions on the authority; and (b) the CHO is satisfied it is necessary to achieve the objects of this Act. (2) Before deciding to vary the conditions, the CHO must: (a) give written notice to the holder of the authority: (i) of the particulars of the proposed variation; and (ii) that the holder may make written submissions to the CHO about the proposed variation within a reasonable period of at least 21 days stated in the notice; and (b) have regard to written submissions made to the CHO by the holder before the stated day; and (c) for a Schedule 8 authorisation issued without considering the Committee's advice – consider the Committee's advice given under section 133. (3) If the CHO decides to vary the conditions of the authority, the CHO must immediately give the holder an information notice for the decision. -- 105 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.5 Variation of conditions of authorities Division 3 Variation of conditions of authority on application by holder Medicines, Poisons and Therapeutic Goods Act 2012 90 Division 3 Variation of conditions of authority on application by holder 158 Application (1) The holder of an authority may apply to the CHO for the variation of the conditions of the authority. (2) The application must be: (a) in the approved form; and (b) accompanied by sufficient documents and information to enable the CHO to decide the application, including the documents and information stated in the approved form. 159 CHO may require further information The CHO may, by written notice, require the applicant to give the CHO further documents or information, within the reasonable period stated in the notice, for considering and deciding the application. 160 Considering and deciding application (1) The CHO must consider the application and either vary, or refuse to vary, the conditions of the authority. (2) The CHO must refuse to vary the conditions of the authority unless satisfied the authority could be issued under Part 3.3 subject to the varied conditions. 161 Notice of decision on application (1) If the CHO decides to vary the conditions of the authority, the CHO must immediately give its holder notice of the decision. (2) If the CHO refuses to vary the conditions of the authority, the CHO must immediately give its holder an information notice for the decision. 162 Failure to decide application The CHO is taken to have refused to vary the conditions of the authority if the CHO does not decide the application within 30 days after: (a) the application is made; or -- 106 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.5 Variation of conditions of authorities Division 4 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 91 (b) if the CHO gives the applicant notice to give the CHO further documents or information – the end of the period stated in the notice for giving the document or information. Division 4 Miscellaneous matters 163 Application of Division This Division applies if the holder of an authority receives: (a) an information notice for the variation of conditions of the authority under section 157(3); or (b) a notice for the variation of conditions of the authority under section 161(1). 164 When variation of conditions takes effect (1) The variation of conditions of the authority takes effect on: (a) the day the notice is given to the holder of the authority; or (b) the later day of effect stated in the notice. (2) In addition, the variation of conditions does not depend on the authority being amended to record the variation or a replacement authority being issued. 165 Recording variation of conditions (1) The holder of the authority must return the authority to the CHO within 14 days after receiving the notice unless the holder has a reasonable excuse. Maximum penalty: 20 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the defendant establishes a reasonable excuse. (4) On receiving the authority, the CHO must: (a) amend the authority to give effect to the variation and return the authority to the holder; or (b) if the CHO is satisfied it is not practicable to amend the authority – issue a replacement authority incorporating the variation and send it to the holder. -- 107 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.6 Suspension and cancellation of authorities Medicines, Poisons and Therapeutic Goods Act 2012 92 Part 3.6 Suspension and cancellation of authorities 166 Grounds for suspending or cancelling authority Each of the following is a ground for suspending or cancelling an authority: (a) its holder, or an agent, contractor or employee of the holder, has contravened a provision of this Act; (b) the authority was issued, renewed or transferred because of a materially false or misleading representation; (c) the CHO becomes aware of information that, if it had been known by the CHO when the authority was issued, renewed or transferred, the CHO would have refused to issue, renew or transfer it; (d) if its holder is not a health practitioner – its holder is not, or is no longer, a suitable person to hold the authority; (e) for a certificate of registration – the nominated person for the certificate is not, or is no longer, a suitable person. 167 Show cause notice (1) If the CHO reasonably believes a ground exists to suspend or cancel an authority, the CHO must give the holder of the authority written notice under this section (a show cause notice). (2) The show cause notice must state the following: (a) the action (the proposed action) the CHO proposes taking under this Part; (b) the grounds for the proposed action; (c) an outline of the facts and circumstances forming the basis for the grounds; (d) if the proposed action is suspension of the authority – the proposed suspension period; (e) an invitation to the holder to make representations within a period stated in the notice (being at least 7 days after the date of the notice) to show cause why the proposed action should not be taken. (3) The holder of the authority may make written representations about the show cause notice to the CHO in the period stated in the notice. -- 108 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.6 Suspension and cancellation of authorities Medicines, Poisons and Therapeutic Goods Act 2012 93 (4) The CHO must consider all written representations made under subsection (3) (the accepted representations). (5) If the proposed action relates to a Schedule 8 authorisation, the CHO must give the Committee all information relevant to the proposed action, including any accepted representations, for its advice. 168 Ending show cause process without further action If, after considering the accepted representations for the show cause notice and, if the proposed action relates to a Schedule 8 authorisation, the Committee's advice, the CHO no longer believes a ground exists to suspend or cancel the authority, the CHO: (a) must not take any further action about the show cause notice; and (b) must give written notice to the holder of the authority that no further action is to be taken about the show cause notice. 169 Suspension or cancellation (1) This section applies if: (a) after considering the accepted representations for the show cause notice and, if the proposed action relates to a Schedule 8 authorisation, the Committee's advice, the CHO: (i) still believes a ground exists to suspend or cancel the authority; and (ii) believes suspension or cancellation of the authority is warranted; or (b) there are no accepted representations for the show cause notice. (2) The CHO may: (a) if the proposed action stated in the show cause notice was to suspend the authority for a stated period – suspend the authority for not longer than the stated period; or (b) if the proposed action stated in the show cause notice was to cancel the authority – either cancel the authority or suspend it for a stated period. (3) The CHO must immediately give an information notice for the decision to the holder of the authority. -- 109 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.6 Suspension and cancellation of authorities Medicines, Poisons and Therapeutic Goods Act 2012 94 (4) The decision takes effect on: (a) the day the information notice is given to the holder; or (b) if a later day of effect is stated in the notice – the later day. 170 Return of cancelled authority to CHO (1) If the CHO has cancelled an authority and given an information notice for the decision to the holder of the authority, the holder must return the authority to the CHO within 14 days after receiving the notice. Maximum penalty: 20 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the defendant establishes a reasonable excuse. 171 Immediate suspension of authority pending formal cancellation procedure (1) This section applies if the CHO is satisfied: (a) a ground exists to cancel an authority; and (b) it is necessary, to protect public health and safety, to immediately suspend the authority until the cancellation procedure under sections 167 to 169 is completed. (2) The CHO must immediately suspend the authority. (3) The CHO must immediately give an information notice for the decision to the holder of the authority. (4) The suspension takes effect immediately after the information notice for the decision is given to the holder. (5) If, within 14 days after the CHO suspends the authority, the CHO gives the holder a show cause notice, the suspension lasts until the first of the following occurs: (a) the CHO cancels the suspension; (b) a decision to cancel the authority takes effect; (c) a decision is made not to cancel the authority. -- 110 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.7 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 95 (6) If a show cause notice is not given to the holder within the 14-day period mentioned in subsection (5), the suspension lapses at the end of the period unless the CHO has already cancelled the suspension. Part 3.7 Miscellaneous matters 172 Medical examination for some authorities (1) This section applies to the following persons: (a) an applicant for a Schedule 7 authorisation or pest management technician licence; (b) the holder of: (i) a Schedule 7 authorisation; or (ii) a pest management technician licence; (c) an employee of a person mentioned in paragraph (b). (2) The CHO may, by written notice given to the person, require the person, within the reasonable time stated in the notice, to: (a) undergo a medical examination; and (b) give the CHO the results of the examination. (3) The person must comply with the notice. Maximum penalty: 20 penalty units. (4) If the CHO is satisfied the results of the medical examination indicate the use or continued use of Schedule 7 substances or pesticides by the person is a threat to the person's health, the CHO may: (a) for a person mentioned in subsection (1)(a) – under section 134(4), refuse to issue the authority; or (b) for a person mentioned in subsection (1)(b)(i): (i) under Part 3.5, vary the conditions of the person's authority; or (ii) under Part 3.6, suspend for a stated period or cancel, the person's authority; or -- 111 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.7 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 96 (c) for a person mentioned in subsection (1)(b)(ii): (i) under Part 3.3, refuse to renew the person's authority; or (ii) under Part 3.5, vary the conditions of the person's authority; or (iii) under Part 3.6, suspend for a stated period or cancel, the person's authority; or (d) for an employee mentioned in subsection (1)(c) – by written notice given to the employee's employer, order the employer to cease employing the employee in any capacity involving the handling of, or exposure to, the Schedule 7 substances or pesticides stated in the order. (5) The CHO must give the employer and employee an information notice for the decision to give the notice under subsection (4)(d). (6) The employer must comply with the notice. Maximum penalty: 50 penalty units. (7) An offence against subsection (3) or (6) is an offence of strict liability. (8) It is a defence to a prosecution for an offence against subsection (3) or (6) if the defendant establishes a reasonable excuse. 173 Authority holder to give notice of change of particulars (1) The holder of an authority commits an offence if: (a) there is a change in a particular contained in the authority; and (b) the particular is prescribed by regulation; and (c) the holder does not give written notice to the CHO about the change within 14 days after the change. Maximum penalty: 20 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the defendant establishes a reasonable excuse. -- 112 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.7 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 97 174 Replacement of authority (1) The CHO may issue a replacement authority to the holder of an authority if satisfied the original authority has been lost, stolen or destroyed. (2) For subsection (1), the CHO may require the holder or, if the authority is a certificate of registration, the nominated person for the authority, to give the CHO a statutory declaration stating the original authority has been lost, stolen or destroyed. 175 Surrender of authority (1) The holder of an authority may surrender the authority by written notice given to the CHO. (2) The surrender takes effect on: (a) the day the notice is given to the CHO; or (b) if a later day of effect is stated in the notice – the later day. (3) The person who held the authority must return it to the CHO within 14 days after the day the surrender takes effect. Maximum penalty: 20 penalty units. (4) An offence against subsection (3) is an offence of strict liability. (5) It is a defence to a prosecution for an offence against subsection (3) if the defendant establishes a reasonable excuse. 176 Display of certificate of registration (1) The holder of a certificate of registration must display the certificate in a prominent place at the registered place. Maximum penalty: 20 penalty units. (2) A retailer licensee must display the licence in a prominent place at the licensed place. Maximum penalty: 20 penalty units. (3) An offence against subsection (1) or (2) is an offence of strict liability. (4) It is a defence to a prosecution for an offence against subsection (1) or (2) if the defendant establishes a reasonable excuse. -- 113 of 187 -- Chapter 3 Authorities to deal with Scheduled substances Part 3.7 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 98 (5) In addition, if the holder of the certificate of registration or licence gives it to the CHO when required by the CHO, the holder does not commit an offence against subsection (1) or (2) while the holder does not have the authority. 177 Authority not personal property For section 8(1)(k) of the Personal Property Securities Act 2009 (Cth), an authority is not personal property for that Act. Note for section 177 A law of the Commonwealth, a State or a Territory may declare a right, licence or authority granted by or under that law not to be personal property for the Personal Property Securities Act 2009 (Cth). -- 114 of 187 -- Chapter 4 Enforcement Part 4.2 Powers of authorised officers to enter places Medicines, Poisons and Therapeutic Goods Act 2012 99 Chapter 4 Enforcement Part 4.1 Interpretation 178 Definitions In this Chapter: at, in relation to a place, includes on and in the place. connected, see section 179. enter, a place, includes re-enter and board the place. occupier, of a place, includes a person who reasonably appears to be an occupier of the place. 179 When thing is connected with offence For this Chapter, a thing is connected with an offence if: (a) the offence has been committed in relation to the thing; or (b) the thing will afford evidence of the commission of the offence; or (c) the thing was used, is being used or is intended to be used, for the purpose of committing the offence. Part 4.2 Powers of authorised officers to enter places 180 Entry of place – general (1) For the administration or enforcement of this Act, an authorised officer may enter: (a) a place (other than a dwelling) at any reasonable time; or (b) any place at any time: (i) with the consent of the occupier of the place; or (ii) under a search warrant issued under this Part for the place. -- 115 of 187 -- Chapter 4 Enforcement Part 4.2 Powers of authorised officers to enter places Medicines, Poisons and Therapeutic Goods Act 2012 100 (2) An authorised officer (other than a police officer in uniform) who enters a place under subsection (1) must not remain at the place if, when asked by the occupier of the place, the officer does not produce for the occupier's inspection: (a) for an authorised officer who is a police officer – the officer's police identification; or (b) for another authorised officer – the officer's identity card. 181 Consent to entry (1) An authorised officer (other than a police officer in uniform) seeking the consent of an occupier of a place to enter the place must produce to the occupier for inspection: (a) for an authorised officer who is a police officer – the officer's police identification; or (b) for another authorised officer – the officer's identity card. (2) In addition, an authorised officer seeking the consent of an occupier of a place to enter the place must: (a) give the occupier the reasons why entry is sought; and (b) inform the occupier that the occupier may refuse to give consent. (3) If: (a) it is material in proceedings for a court to be satisfied the occupier consented to entry under this Part; and (b) written consent of the occupier is not produced in evidence; the court may presume, in the absence of evidence to the contrary, the occupier did not give consent. 182 Entry of place – search warrant (1) An authorised officer may apply to a justice of the peace, by information on oath, for a search warrant for a place if the officer reasonably believes an offence against this Act is about to be, is being or has been committed at the place. (2) The justice of the peace may issue a search warrant only if satisfied about the matters set out in the information. -- 116 of 187 -- Chapter 4 Enforcement Part 4.2 Powers of authorised officers to enter places Medicines, Poisons and Therapeutic Goods Act 2012 101 (3) The warrant authorises the officer named in the warrant, and any other person helping the officer, to enter the place and to exercise an authorised officer's powers under this Part. (4) The warrant must state: (a) the purpose for which it is issued; and (b) the nature of the offence or contravention for which the entry is authorised; and (c) the hours during which entry to the place is authorised or state that the entry is authorised at any time of the day or night; and (d) the date, within 30 days after the warrant's issue, the warrant ceases to have effect. (5) The authorised officer executing the warrant must, if asked by the occupier of the place or another person at the place, produce the warrant for the person's inspection. 183 Entry to Aboriginal land (1) An authorised officer's powers in relation to a place under this Part include powers in relation to Aboriginal land even though the officer does not hold a permit to enter Aboriginal land under the Aboriginal Land Act 1978. (2) In this section: Aboriginal land, see section 3(1) of the Aboriginal Land Rights (Northern Territory) Act 1976 (Cth). 184 Additional powers for entry of aircraft, vehicle or vessel (1) This section applies if an authorised officer has reasonable grounds for suspecting: (a) an aircraft, vehicle or vessel is being, has been or is likely to be, used in the commission of an offence against this Act; or (b) an aircraft, vehicle or vessel, or a thing in or on an aircraft, vehicle or vessel, may provide evidence of the commission of an offence against this Act. (2) For entering the aircraft, vehicle or vessel under this Part, the authorised officer may require the person in control of the aircraft, vehicle or vessel: (a) to stop, move or not to move it; or -- 117 of 187 -- Chapter 4 Enforcement Part 4.3 Powers of authorised officers on entry of places Medicines, Poisons and Therapeutic Goods Act 2012 102 (b) to bring it to a stated place and remain in control of it until the officer permits it to depart; or (c) to give the officer reasonable help. (3) A person commits an offence if the person engages in conduct that results in a contravention of the authorised officer's requirement. Maximum penalty: 100 penalty units. (4) It is a defence to a prosecution for an offence against subsection (3) if the defendant establishes a reasonable excuse. Part 4.3 Powers of authorised officers on entry of places 185 Powers on entry of place (1) An authorised officer who enters a place under Part 4.2 may do any of the following: (a) inspect or examine the place or anything found at the place; (b) break open and search fixtures and fittings, furniture and furnishings or boxes, packages and other containers found at the place; (c) take measurements of, or conduct tests in relation to, the place or anything found at the place; (d) take photographs, films or audio, video or other recordings of the place or anything found at the place; (e) take and remove from the place samples for analysis of anything found at the place; (f) take copies of, or extracts from, documents found at the place; (g) require a person at the place to: (i) answer questions or provide information; or (ii) make available documents kept at the place; or (iii) give the officer reasonable help to exercise powers under this section; (h) subject to section 186: (i) seize anything found at the place; or -- 118 of 187 -- Chapter 4 Enforcement Part 4.3 Powers of authorised officers on entry of places Medicines, Poisons and Therapeutic Goods Act 2012 103 (ii) if the place is an aircraft, vehicle or vessel – seize it. (2) After taking a sample under subsection (1)(e) or seizing a thing under subsection (1)(h), the authorised officer must give a receipt for the sample or thing to: (a) the occupier of the place; or (b) the person whom the authorised officer reasonably believes had possession or control of the sample or thing immediately before it was taken or seized. (3) A requirement under subsection (1)(g) must be given by written notice. (4) When making the requirement, the authorised officer must inform the person it is an offence not to comply with the requirement unless the person establishes a reasonable excuse. (5) The person must comply with the requirement. Maximum penalty: 100 penalty units. (6) It is a defence to a prosecution for an offence against subsection (5) if the defendant establishes a reasonable excuse. (7) Without limiting subsection (6), it is a reasonable excuse for an individual to fail to answer a question under subsection (1)(g)(i) if complying with the requirement might tend to incriminate the individual. 186 Restriction on power of seizure An authorised officer may seize a thing under section 185(1)(h) only if the officer reasonably believes the thing: (a) is connected with an offence against this Act and the seizure is necessary to prevent the thing from being: (i) concealed, lost, damaged or destroyed; or (ii) used to commit the offence; or (b) is connected with an offence against this Act and the seizure is necessary to conduct tests for adducing evidence for a prosecution for the offence. -- 119 of 187 -- Chapter 4 Enforcement Part 4.4 Seized and forfeited things Division 1 Notice, retention and return of seized thing Medicines, Poisons and Therapeutic Goods Act 2012 104 187 Authorised officer may use help and force in exercising powers An authorised officer may exercise a power under this Part with the help, and using the force, that is reasonable in the circumstances. Part 4.4 Seized and forfeited things Division 1 Notice, retention and return of seized thing 188 Application of Division This Division applies if, under Part 4.3, an authorised officer seizes a thing (the seized thing). 189 Notice of seizure of thing (1) As soon as practicable after seizing the thing, the authorised officer must give written notice of the seizure to the person from whom it is seized. (2) The notice must include the following details: (a) a description of the thing; (b) the reason for seizing the thing; (c) details of the right under section 192 to apply to the Local Court for an order disallowing the seizure; (d) if the thing has been removed from the place where it was seized – the address of the place where the thing is held. 190 Retention of thing seized (1) An authorised officer may, until the start of a proceeding for an offence against this Act in relation to the seized thing and (if necessary) during the proceeding: (a) keep the thing at the place where it was found; or (b) remove the thing to another place and keep it there in the officer's possession or under the officer's control. (2) If the thing is kept under subsection (1)(a), an authorised officer: (a) must ensure the thing is identified in a way that indicates it has been seized under this Act; and -- 120 of 187 -- Chapter 4 Enforcement Part 4.4 Seized and forfeited things Division 2 Order disallowing seizure of seized thing Medicines, Poisons and Therapeutic Goods Act 2012 105 (b) may physically segregate the thing. Examples for subsection (2) 1 The seized thing could be placed in an appropriately labelled container. 2 A barrier with appropriate signs could be placed around the seized thing. (3) A person commits an offence if the person: (a) interferes with or disposes of the seized thing; or (b) removes the seized thing from: (i) the place it was seized; or (ii) the place to which it was removed by an authorised officer. Maximum penalty: 100 penalty units. (4) Subsection (3) does not apply if the person has the written consent of the CHO. 191 Return of seized thing If, before the seized thing is forfeited to the Territory under section 197, the CHO becomes satisfied no offence relating to the thing has been committed against this Act, the CHO must, as soon as practicable, deliver the thing to the person who appears to the CHO to be entitled to it. Division 2 Order disallowing seizure of seized thing 192 Application for order disallowing seizure A person may apply to the Local Court for an order disallowing the seizure of a seized thing within 3 days after it is seized. 193 CHO is respondent to application The CHO is the respondent to the application. Note for section 193 Under the Local Court (Civil Jurisdiction) Rules 1998, the applicant must serve a copy of the application on the CHO. -- 121 of 187 -- Chapter 4 Enforcement Part 4.4 Seized and forfeited things Division 2 Order disallowing seizure of seized thing Medicines, Poisons and Therapeutic Goods Act 2012 106 194 Order disallowing seizure (1) On hearing the application, the Local Court must make an order disallowing the seizure of the seized thing if the Court is satisfied: (a) it is: (i) proved the applicant would be entitled to the thing if it had not been seized; and (ii) not proved an offence relating to the thing has been committed against this Act; or (b) there are exceptional circumstances justifying the making of the order. (2) Otherwise, the Court must dismiss the application. 195 Ancillary orders (1) If the Local Court makes an order disallowing the seizure of the seized thing, the Court must also make one or both of the following orders: (a) an order directing the CHO to deliver the seized thing to the applicant; (b) if the thing cannot for any reason be delivered or has, as a consequence of being seized, depreciated in value – an order directing the CHO to pay to the applicant the amount of compensation the Court considers just. (2) The Court may make the orders as to costs as it considers just. 196 Adjournment pending hearing of other proceeding (1) The Local Court may adjourn the hearing of the application if it appears to the Court the seized thing is required to be produced in evidence in a proceeding (which may be pending) in connection with an offence against this Act or another law of the Territory. (2) The adjournment may be made on the application of the CHO or on the Court's initiative. (3) The adjournment may be until the proceeding in connection with the offence is decided. -- 122 of 187 -- Chapter 4 Enforcement Part 4.4 Seized and forfeited things Division 3 Forfeiture of seized thing Medicines, Poisons and Therapeutic Goods Act 2012 107 Division 3 Forfeiture of seized thing 197 When seized thing is forfeited A seized thing is forfeited to the Territory: (a) if it is not returned under section 191 and no application for an order disallowing its seizure is made under section 192 on the expiry of the period within which an application may be made under that section; or (b) if an application for an order disallowing its seizure under section 192 is withdrawn or dismissed – on the date of the withdrawal or dismissal. 198 Destruction or disposal of forfeited thing (1) The CHO may destroy, sell or otherwise dispose of a thing forfeited to the Territory under section 197 (the forfeited thing). (2) A person who was, immediately before the forfeiture, the owner of the forfeited thing is liable for the costs incurred for its destruction, sale or disposal (including any storage costs). (3) The costs are a debt due to the Territory by the owner. (4) In a proceeding for the recovery of the debt, a certificate signed by the CHO stating the amount of the costs and the way in which they were incurred is evidence of the matters stated. 199 Return of forfeited thing (1) This section applies if: (a) the CHO becomes satisfied no offence relating to the forfeited thing has been committed against this Act; and (b) the thing has not been destroyed or disposed of in a way that would prevent its return. (2) The CHO must, as soon as practicable, deliver the thing to: (a) the person from whom it was seized; or (b) if the CHO is satisfied another person is entitled to it – the other person. (3) On the delivery of the thing to the person, any proprietary and other interests in the thing that existed immediately before its forfeiture are restored. -- 123 of 187 -- Chapter 4 Enforcement Part 4.5 General powers of CHO and authorised officers Medicines, Poisons and Therapeutic Goods Act 2012 108 200 Compensation to be paid in certain circumstances (1) A person may apply to the CHO for compensation for the forfeited thing. (2) The Territory is liable to pay just compensation to the applicant in relation to the thing if: (a) no offence relating to the thing has been committed against this Act; and (b) the thing: (i) cannot be returned; or (ii) has, as a consequence of being seized, depreciated in value; and (c) the CHO is satisfied the applicant would be entitled to the thing if it had not been forfeited. (3) The CHO must: (a) decide the amount of compensation to be paid; and (b) give written notice to the applicant of the decision. (4) The notice must include an information notice. Part 4.5 General powers of CHO and authorised officers 201 Compliance notice (1) The CHO may give a notice (a compliance notice) to a person if the CHO reasonably believes: (a) the person is the occupier of a place where: (i) an activity is being carried out in contravention of, or likely to be in contravention of, this Act; or (ii) an activity has been carried out in contravention of this Act and it is likely the contravention will be repeated; or (b) the person: (i) is carrying out an activity in contravention of, or likely to be in contravention of, this Act; or -- 124 of 187 -- Chapter 4 Enforcement Part 4.5 General powers of CHO and authorised officers Medicines, Poisons and Therapeutic Goods Act 2012 109 (ii) has carried out an activity in contravention of this Act and it is likely the person will repeat the contravention. (2) The notice must state the following: (a) the reasons the CHO has given the notice; (b) the person must rectify the circumstances that gave rise to the notice; (c) the period within which the person must comply with the notice; (d) if the CHO considers it appropriate – the action recommended (but not required) to be taken. (3) The notice must include an information notice. 202 Contravention of compliance notice (1) A person commits an offence if: (a) a compliance notice is given to the person; and (b) the person engages in conduct that results in a contravention of the notice. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) It is a defence to a prosecution for an offence against subsection (1) if the defendant establishes a reasonable excuse. (3) To avoid doubt, a person does not commit an offence against subsection (1) merely because the person does not take the action recommended by the CHO. 203 Power to prohibit supply of incorrectly packed or labelled substance (1) The CHO may, by written notice, order a person not to supply a Scheduled substance that is not packed or labelled as required under this Act. (2) The person must comply with the notice. Maximum penalty: 100 penalty units. (3) An offence against subsection (2) is an offence of strict liability. -- 125 of 187 -- Chapter 4 Enforcement Part 4.5 General powers of CHO and authorised officers Medicines, Poisons and Therapeutic Goods Act 2012 110 204 Power to require name and address (1) This section applies if an authorised officer: (a) finds a person committing an offence against this Act; or (b) finds a person in circumstances that lead the officer to reasonably suspect the person has just committed an offence against this Act; or (c) has information that leads the officer to reasonably suspect a person has just committed an offence against this Act. (2) The authorised officer may require the person to state the person's name and address. (3) When making the requirement, the authorised officer must inform the person it is an offence to contravene the requirement unless the person establishes a reasonable excuse. (4) The authorised officer may require the person to give evidence of the correctness of the person's name or address if the officer reasonably suspects the name or address given is false. (5) A person must comply with a requirement made under this section by an authorised officer. Maximum penalty: 100 penalty units. (6) An offence against subsection (5) is an offence of strict liability. (7) It is a defence to a prosecution for an offence against subsection (5) if the defendant establishes a reasonable excuse. 205 Power to require information from persons (1) This section applies if an authorised officer reasonably suspects: (a) an offence against this Act has been committed; and (b) a person may be able to give information about the offence. (2) The authorised officer may require the person to give information about the suspected offence. (3) When making the requirement, the authorised officer must inform the person it is an offence to fail to give the information unless the person establishes a reasonable excuse. -- 126 of 187 -- Chapter 4 Enforcement Part 4.6 Other offences Medicines, Poisons and Therapeutic Goods Act 2012 111 (4) The person must comply with the requirement. Maximum penalty: 100 penalty units. (5) An offence against subsection (4) is an offence of strict liability. (6) It is a defence to a prosecution for an offence against subsection (4) if the defendant establishes a reasonable excuse. 206 Requirement to give documents or information (1) This section applies if a person has given a notice or other document under this Act about the person's dealing with a Scheduled substance. (2) The CHO may, by written notice, require the person to give the CHO further documents or information relating to the dealing (whether described generally or specifically) within the reasonable period stated in the notice. (3) The person must comply with the notice. Maximum penalty: 100 penalty units. (4) An offence against subsection (3) is an offence of strict liability. (5) It is a defence to a prosecution for an offence against subsection (3) if the defendant establishes a reasonable excuse. Part 4.6 Other offences 207 Offence to disclose certain information (1) A person commits an offence if: (a) the person: (i) obtains information in the course of performing a function connected with the administration of this Act or exercising a power under this Act; or (ii) is given substance information under an authorisation under section 257(1); and (b) the information is confidential and the person is reckless in relation to that circumstance; and (c) the person intentionally engages in conduct; and -- 127 of 187 -- Chapter 4 Enforcement Part 4.6 Other offences Medicines, Poisons and Therapeutic Goods Act 2012 112 (d) the conduct results in the disclosure of the information and the disclosure is not: (i) for a purpose connected with the administration of this Act, including a legal or disciplinary proceeding arising out of the operation of this Act; or (ii) to a person who is otherwise entitled to the information; or (iii) to a person authorised under section 251(1) to be given the information; or (iv) to a person exercising a power or performing a function under a corresponding law; or (v) to a health profession body; or (vi) to a law enforcement agency; or (vii) in accordance with Chapter 7, Part 7.1AA; and (e) the person is reckless in relation to the result and circumstance referred to in paragraph (d). Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Strict liability applies to subsection (1)(a). (3) If the information referred to in subsection (1) relates to a particular person (the patient), it is a defence to a prosecution for an offence against that subsection if the information is disclosed: (a) with the patient's consent; or (b) to a health service provider for providing a health service to the patient. (4) In this section: health profession body means a National Health Practitioner Board established under the Health Practitioner Regulation National Law. health service provider, see section 5 of the Health Practitioner Regulation National Law. -- 128 of 187 -- Chapter 4 Enforcement Part 4.6 Other offences Medicines, Poisons and Therapeutic Goods Act 2012 113 law enforcement agency, see section 4 of the Information Act 2002. Note for section 207 In addition to the circumstances mentioned in this section, a person who discloses information mentioned in this section will not be criminally responsible for an offence if the disclosure is justified or excused by or under a law (see section 43BE of the Criminal Code). 208 Misleading information (1) A person commits an offence if: (a) the person gives information to another person; and (b) the other person is an authorised officer; and (c) the person knows the information is misleading; and (d) the person knows the authorised officer is acting in an authorised officer capacity. Maximum penalty: 200 penalty units or imprisonment for 12 months. (2) A person commits an offence if: (a) the person gives a document to another person; and (b) the other person is an authorised officer; and (c) the person knows the document contains misleading information; and (d) the person knows the authorised officer is acting in an authorised officer capacity. Maximum penalty: 200 penalty units or imprisonment for 12 months. (3) Strict liability applies to subsections (1)(b) and (2)(b). (4) Subsection (2) does not apply if the person, when giving the document: (a) draws the misleading aspect of the document to the authorised officer's attention; and (b) to the extent to which the person can reasonably do so – gives the authorised officer the information necessary to remedy the misleading aspect of the document. -- 129 of 187 -- Chapter 4 Enforcement Part 4.6 Other offences Medicines, Poisons and Therapeutic Goods Act 2012 114 (5) In this section: misleading information means information that is misleading in a material particular or because of the omission of a material particular. 209 Obstruction of authorised officer or assistant (1) A person commits an offence if the person: (a) obstructs an authorised officer, or person assisting an authorised officer, acting in an official capacity; and (b) knows the authorised officer is, or person is assisting, an authorised officer acting in an official capacity. Maximum penalty: 100 penalty units. (2) It is a defence to a prosecution for an offence against subsection (1) if the defendant establishes a reasonable excuse. (3) In this section: obstruct includes resist and hinder. 210 Falsely representing to be authorised officer (1) A person commits an offence if: (a) the person represents, by words or conduct, that the person or another person is an authorised officer; and (b) the person or other person is not an authorised officer; and (c) the person makes the representation with an intention to deceive. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) Strict liability applies to subsection (1)(b). 211 Bribery of authorised officer A person commits an offence if the person: (a) knows an authorised officer is acting in an official capacity; and -- 130 of 187 -- Chapter 4 Enforcement Part 4.7 Legal proceedings and evidentiary matters Division 1 Criminal liability for offences Medicines, Poisons and Therapeutic Goods Act 2012 115 (b) gives, offers or promises a bribe to the authorised officer with the intention of influencing the authorised officer. Maximum penalty: 200 penalty units or imprisonment for 2 years. Part 4.7 Legal proceedings and evidentiary matters Division 1 Criminal liability for offences 212 Definitions In this Division: declared provision means any of the following provisions: (a) a provision of this Act mentioned in Schedule 1; (b) a provision of the Regulations prescribed by regulation. representative, of a person, means an employee or agent of the person. 213 Liability of representative (1) It is not a defence to a prosecution for an offence against a declared provision that the defendant was, at the time of the commission of the offence, another person's representative. (2) However, it is a defence if the defendant proves the defendant was, at the time of the commission of the offence: (a) another person's representative; and (b) acting as the other person's representative under the direct or indirect supervision of the other person. 214 Conduct of representative (1) This section applies to a prosecution for an offence against a declared provision. Note for subsection (1) This section deals with prosecutions of individuals. Part IIAA, Division 5, of the Criminal Code contains provisions about corporate criminal responsibility. (2) Conduct engaged in by a representative of a person within the scope of the representative's actual or apparent authority is taken to have been also engaged in by the person. -- 131 of 187 -- Chapter 4 Enforcement Part 4.7 Legal proceedings and evidentiary matters Division 1 Criminal liability for offences Medicines, Poisons and Therapeutic Goods Act 2012 116 (3) However, subsection (2) does not apply if the person proves the person took reasonable steps to prevent the conduct. (4) In deciding whether the person took reasonable steps to prevent the conduct, a court must consider: (a) any action the person took to ensure the representative had a reasonable knowledge and understanding of the requirement to comply with the contravened provision; and (b) the level of management, control or supervision that was appropriate for the person to exercise over the representative. (5) Subsection (4) does not limit the matters the court may consider. (6) If it is relevant to prove a person had a fault element in relation to a physical element of an offence, it is enough to show: (a) the conduct relevant to the physical element was engaged in by a representative of the person within the scope of the representative's actual or apparent authority; and (b) the representative had the fault element in relation to the physical element. (7) A person may rely on section 43AX of the Criminal Code in relation to conduct by a representative that would be an offence by the person only if: (a) the representative was under a mistaken but reasonable belief about the facts that, had they existed, would have meant that the conduct would not have constituted an offence; and (b) the person proves the person exercised due diligence to prevent the conduct. Note for subsection (7) Section 43AX of the Criminal Code provides a person is not criminally responsible if the person engaged in conduct under a mistake of fact in relation to an offence of strict liability. (8) A person (the defendant) may not rely on section 43BA of the Criminal Code in relation to a physical element of an offence brought about by another person if the other person is a representative of the defendant. Note for subsection (8) Section 43BA of the Criminal Code provides a person is not criminally responsible in circumstances of an intervening conduct or event. -- 132 of 187 -- Chapter 4 Enforcement Part 4.7 Legal proceedings and evidentiary matters Division 1 Criminal liability for offences Medicines, Poisons and Therapeutic Goods Act 2012 117 (9) A person who is convicted of an offence cannot be punished by imprisonment for the offence if the person would not have been convicted of the offence without subsection (2) or (6). (10) In this section: fault element includes intention, knowledge, recklessness, opinion, belief and purpose, but does not include negligence. person means an individual. 215 Criminal liability of executive officer of body corporate (1) An executive officer of a body corporate commits an offence if: (a) the body corporate commits an offence by contravening a declared EO liability provision (a relevant offence) and the officer was reckless about whether the contravention would happen; and (b) the officer was in a position to influence the conduct of the body corporate in relation to the contravention; and (c) the officer recklessly failed to take reasonable steps to prevent the contravention. Maximum penalty: The maximum penalty that may be imposed on an individual for the relevant offence. (1A) Strict liability applies to subsection (1)(b). (2) In deciding whether the executive officer took (or failed to take) reasonable steps to prevent the contravention, a court must consider the following: (a) any action the officer took directed towards ensuring the following (to the extent the action is relevant to the contravention): (i) the body corporate arranged regular professional assessments of the body corporate's compliance with the declared EO liability provision; (ii) the body corporate implemented any appropriate recommendation arising from an assessment under subparagraph (i); -- 133 of 187 -- Chapter 4 Enforcement Part 4.7 Legal proceedings and evidentiary matters Division 2 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 118 (iii) the body corporate's representatives and contractors had a reasonable knowledge and understanding of the requirement to comply with the declared EO liability provision; (b) any action the officer took when the officer became aware that the contravention was, or could be, about to happen. (3) Subsection (2) does not limit the matters the court may consider. (4) This section does not affect the liability of the body corporate. (5) This section applies whether or not the body corporate is prosecuted for, or found guiltyof, the relevant offence. (6) This section does not apply if the body corporate would have a defence to a prosecution for the relevant offence. (7) In this section: declared EO liability provision means: (a) section 37, 39, 40, 41, 42, 43(1) or (2), 44(2), 46, 47, 49, 50, 51, 52(1), 53, 54(1), 110(1), (2) or (3), 111(1), (2) or (3), 112, 113(1) or (2) or 115(4); or (b) a provision of the Regulations prescribed by regulation. Division 2 Miscellaneous matters 216 Self-incrimination (1) A person required to answer a question, give information or produce a document under this Act is not excused from doing so on the ground that the answer, information or document might tend to incriminate the person or make the person liable to a penalty. (2) However, the answer, information or document is not admissible in evidence against the person in a civil or criminal proceeding except a proceeding for an offence in which the falsity or misleading nature of the answer, information or document is relevant. 217 Judicial notice In any proceeding, a signature purporting to be the signature of the CHO is evidence of the signature it purports to be. -- 134 of 187 -- Chapter 4 Enforcement Part 4.7 Legal proceedings and evidentiary matters Division 2 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 119 218 Time for starting offence proceeding A prosecution for an offence against this Act must be started within 2 years after the offence is alleged to have been committed. 219 Evidentiary certificate (1) In a proceeding for an offence against this Act, a certificate signed by the CHO stating any of the following matters is evidence of the matter: (a) a person was or was not the holder of an authority; (b) a document is a copy of an authority or notice issued or given under this Act; (c) an authority was or was not in force in relation to a place; (d) an authority authorised or did not authorise the dealing with a Scheduled substance; (e) an authority was or was not subject to conditions; (f) an authority was suspended or cancelled; (g) a substance was or was not a Scheduled substance; (h) a person was the CHO or an authorised officer; (i) a person was given a notice under this Act. (j) another thing prescribed by regulation. (2) In subsection (1), a reference to a person, place or thing is a reference to a person, place or thing stated in the certificate. (3) The certificate may state anything by reference to a date or period. -- 135 of 187 -- Chapter 5 Reconsideration and review of decisions Medicines, Poisons and Therapeutic Goods Act 2012 120 Chapter 5 Reconsideration and review of decisions 220 Meaning of original decision and affected person (1) An original decision is a decision mentioned in Schedule 2. (2) The affected person, for an original decision, is the person mentioned in Schedule 2 for the decision. 221 Request for reconsideration of original decision (1) The affected person for an original decision may request a reconsideration of the decision. (2) The request must be made within 28 days after: (a) the affected person receives an information notice for the decision; or (b) otherwise – the affected person becomes aware of the decision. (3) The request must: (a) be in writing; and (b) state the grounds on which it is made and the facts relied on to establish the grounds. 222 Operation and implementation of original decision (1) The request for the reconsideration of the original decision does not affect the operation or implementation of the decision. (2) Also, the validity of the original decision is not affected by a failure to give an information notice to an affected person for the decision. 223 Reconsideration of decision (1) Within 28 days after the request is made, the CHO must: (a) reconsider the decision; and (b) give the affected person a written notice (a review notice) about the CHO's decision (the reconsidered decision). (2) The review notice must state the following: (a) the reconsidered decision and the reasons for it; -- 136 of 187 -- Chapter 5 Reconsideration and review of decisions Medicines, Poisons and Therapeutic Goods Act 2012 121 (b) that the affected person may apply to the Local Court for a review of the merits of the reconsidered decision; (c) the period allowed for applying for a review of the reconsidered decision; (d) how to apply for a review. (3) The validity of the reconsidered decision is not affected by a failure to give a review notice to the affected person for the decision. 224 Application for review of reconsidered decision (1) The affected person for the original decision may apply to the Local Court for a review of the merits of the reconsidered decision. (2) The application must be made within 28 days after: (a) the affected person receives a review notice about the reconsidered decision; or (b) otherwise – the affected person becomes aware of the decision. (3) However, on application by the affected person, the Local Court may at any time extend the period allowed for applying for a review of the reconsidered decision. 225 Operation and implementation of reconsidered decision (1) The application for the review of the reconsidered decision does not affect the operation or implementation of the decision. (2) However, the Local Court may make an order staying or otherwise varying the operation or implementation of so much of the reconsidered decision as the Court considers appropriate. (3) The order is subject to the conditions stated in it. (4) The order has effect for the period stated in it or, if no period is stated, until the Local Court decides the application. 226 Review procedure (1) In hearing the application, the Local Court must review afresh the merits of the reconsidered decision. (2) In doing so, the Local Court is not bound by anything done by the CHO in making the reconsidered decision. -- 137 of 187 -- Chapter 5 Reconsideration and review of decisions Medicines, Poisons and Therapeutic Goods Act 2012 122 (3) Without limiting subsection (2), the Local Court may: (a) consider evidence that was not considered by the CHO; and (b) disregard evidence that was considered by the CHO. 227 Decision on review (1) In deciding the application, the Local Court may: (a) confirm the reconsidered decision; or (b) vary the reconsidered decision; or (c) set aside the reconsidered decision and substitute its own decision; or (d) set aside the reconsidered decision and refer the matter to which the application relates to the CHO for reconsideration. (2) In referring the matter to the CHO, the Local Court must give the directions it considers appropriate for the reconsideration of the matter. (3) The Local Court may make the incidental orders it considers appropriate to give effect to its decision. (4) A decision under subsection (1)(b) or (c) is taken for this Act (other than this Part) to be the CHO's decision. -- 138 of 187 -- Chapter 6 Therapeutic Goods Act applies as a law of the Territory Part 6.1 Interpretation Medicines, Poisons and Therapeutic Goods Act 2012 123 Chapter 6 Therapeutic Goods Act applies as a law of the Territory Part 6.1 Interpretation 228 Definitions In this Chapter: applied provisions means the Therapeutic Goods Act that applies as a law of the Territory because of section 230, including any modification under section 231. Commonwealth administrative laws means the following Acts: (a) the Administrative Review Tribunal Act 2024 (Cth) (excluding Part 7); (b) the Freedom of Information Act 1982 (Cth); (c) the Ombudsman Act 1976 (Cth); (d) the Privacy Act 1988 (Cth). Commonwealth Minister means the minister responsible for administering the Therapeutic Goods Act. Commonwealth official means: (a) the Commonwealth Secretary; or (b) an authorised person or any other officer mentioned in the Therapeutic Goods Act. Commonwealth Secretary, see section 3(1) of the Therapeutic Goods Act. modifications includes additions, omissions and substitutions. 229 Words have meanings in Therapeutic Goods Act (1) A word defined in the Therapeutic Goods Act has the same meaning in this Act. (2) Subsection (1) has effect subject to a contrary intention. -- 139 of 187 -- Chapter 6 Therapeutic Goods Act applies as a law of the Territory Part 6.3 Functions and powers under applied provisions Medicines, Poisons and Therapeutic Goods Act 2012 124 Part 6.2 Applied provisions 230 Application of Therapeutic Goods Act as law of Territory The Therapeutic Goods Act, as modified under this Act, applies as a law of the Territory, and the Therapeutic Goods Act so applies as if it extended to: (a) things done or omitted to be done by persons who are not corporations; and (b) things done or omitted to be done in the course of trade and commerce within the limits of the Territory. 231 Modification of Therapeutic Goods Act (1) A regulation may modify the Therapeutic Goods Act. (2) Without limiting subsection (1), a regulation may provide that the Act applies under section 230 as if an amendment of it made by a stated Commonwealth law had not taken effect. 232 Interpretation of applied provisions (1) The Acts Interpretation Act 1901 (Cth) applies as a law of the Territory in relation to the interpretation of the applied provisions. (2) That Act so applies as if the applied provisions were a Commonwealth Act or were regulations or other instruments under a Commonwealth Act, as the case requires. (3) The Interpretation Act 1978 of the Territory does not apply to the applied provisions. Part 6.3 Functions and powers under applied provisions 233 Functions and powers of Commonwealth Minister and officials The Commonwealth Minister and a Commonwealth official have the same functions and powers under the applied provisions as they have under the Therapeutic Goods Act as that Act applies to the Commonwealth. -- 140 of 187 -- Chapter 6 Therapeutic Goods Act applies as a law of the Territory Part 6.4 Administrative law Medicines, Poisons and Therapeutic Goods Act 2012 125 234 Delegations by Commonwealth Minister and Secretary A delegation by the Commonwealth Minister or Commonwealth Secretary under the Therapeutic Goods Act is taken to extend to, and have effect for, the corresponding provision of the applied provisions. 235 Appointments under Therapeutic Goods Act The appointment of a person to an office or position under a provision of the Therapeutic Goods Act is taken to extend to, and have effect for, the applied provisions. Part 6.4 Administrative law 236 Application of Commonwealth administrative laws to applied provisions (1) The Commonwealth administrative laws apply as laws of the Territory to any matter arising in relation to the applied provisions as if the provisions were a law of the Commonwealth and not a law of the Territory. (2) For a law of the Territory, a matter arising in relation to the applied provisions: (a) is taken to be a matter arising in relation to laws of the Commonwealth in the same way as if the provisions were a law of the Commonwealth; and (b) is taken not to be a matter arising in relation to laws of the Territory. (3) Subsection (2) has effect for a law of the Territory except as provided by regulation. (4) A provision of a Commonwealth administrative law applying because of this section that purports to confer jurisdiction on a federal court is taken not to have that effect. (5) For this section, a reference in a provision of the Administrative Review Tribunal Act 2024 (Cth) (as that provision applies as a law of this jurisdiction) to the whole or any part of Part 7 of that Act is taken to be a reference to the whole or any part of that Part as it has effect as a law of the Commonwealth. -- 141 of 187 -- Chapter 6 Therapeutic Goods Act applies as a law of the Territory Part 6.5 Offences under applied provisions Medicines, Poisons and Therapeutic Goods Act 2012 126 237 Functions and powers conferred on Commonwealth officers and authorities (1) A Commonwealth administrative law applying because of section 236 that confers on a Commonwealth officer or Commonwealth authority a function or power also confers on the officer or authority the same function or power in relation to a matter arising in relation to the applied provisions. (2) In performing a function or exercising a power conferred by this section, the Commonwealth officer or Commonwealth authority must act as nearly as practicable as the officer or authority would act in performing or exercising the same function or power under the Commonwealth administrative law. Part 6.5 Offences under applied provisions 238 Object of Part (1) The object of this Part is to further the object of this Act by providing for an offence against the applied provisions to be treated as if it were an offence against a Commonwealth law. (2) The purposes for which an offence is to be so treated include, for example (but without limitation) the following: (a) the investigation and prosecution of offences; (b) the arrest, custody, bail, trial and conviction of offenders or persons charged with offences; (c) proceedings relating to a matter referred to in paragraph (a) or (b); (d) appeals and reviews relating to criminal proceedings and to proceedings of the kind referred to in paragraph (c); (e) the sentencing, punishment and release of persons convicted of offences; (f) fines, penalties and forfeitures; (g) liability to make reparation in connection with offences; (h) proceeds of crime; (i) spent convictions. -- 142 of 187 -- Chapter 6 Therapeutic Goods Act applies as a law of the Territory Part 6.5 Offences under applied provisions Medicines, Poisons and Therapeutic Goods Act 2012 127 239 Application of Commonwealth criminal laws to offences against applied provisions (1) The relevant Commonwealth laws apply as laws of the Territory in relation to an offence against the applied provisions as if the provisions were a law of the Commonwealth and not a law of the Territory. (2) For a law of the Territory, an offence against the applied provisions: (a) is taken to be an offence against the laws of the Commonwealth in the same way as if the provisions were a law of the Commonwealth; and (b) is taken not to be an offence against the laws of the Territory. (3) Subsection (2) has effect for a law of the Territory except as provided by regulation. 240 Functions and powers conferred on Commonwealth officials relating to offences (1) A Commonwealth law applying because of section 239 that confers on a Commonwealth official a function or power in relation to an offence against the Therapeutic Goods Act also confers on the official the same function or power in relation to an offence against the corresponding provision of the applied provisions. (2) In performing a function or exercising a power conferred by this section, the Commonwealth official must act as nearly as practicable as the official would act in performing or exercising the same function or power in relation to an offence against the corresponding provision of the Therapeutic Goods Act. 241 No double jeopardy for offences against applied provisions If: (a) an act or omission is an offence against both the applied provisions and the Therapeutic Goods Act; and (b) the offender has been punished for the offence under the Therapeutic Goods Act; the offender is not liable to be punished for the offence under the applied provisions. -- 143 of 187 -- Chapter 6 Therapeutic Goods Act applies as a law of the Territory Part 6.6 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 128 Part 6.6 Miscellaneous matters 242 Reference in Commonwealth law to provision of another law For sections 236 and 239, a reference in a Commonwealth law to a provision of that or another Commonwealth law is taken to be a reference to the provision as applying because of the section. 243 Fees and other money A fee, penalty, fine and other money that, under this Chapter and the applied provisions, are authorised or directed to be payable by or imposed on any person (other than an amount ordered to be refunded to another person) must be paid to the Commonwealth. -- 144 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 1 Interpretation Medicines, Poisons and Therapeutic Goods Act 2012 129 Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 1 Interpretation 243A Definitions In this Part: corresponding law means a law of the Commonwealth, a State or another Territory that: (a) provides for the establishment of a database about monitored medicines; or (b) is prescribed by regulation to be a corresponding law for this Part. data source entity means a person or entity approved by the CHO under section 243N. monitored medicine means: (a) a Schedule 8 substance; or (b) any other Scheduled substance prescribed by regulation. monitored medicines database, see section 243C(1). recordable prescription, see section 243B(1) and (2). recordable supply, see section 243B(3) and (4). relevant prescriber means a dentist, doctor, endorsed midwife, nurse practitioner, podiatrist or another health practitioner prescribed by regulation. 243B Meaning of recordable prescription and recordable supply (1) A recordable prescription is a prescription for a monitored medicine that: (a) is issued to a person in the Territory; or (b) is issued outside the Territory to a person who is ordinarily resident in the Territory; or -- 145 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 2 Establishment and maintenance of monitored medicines database Medicines, Poisons and Therapeutic Goods Act 2012 130 (c) is issued outside the Territory to a person who has the prescription filled in the Territory; or (d) is issued in circumstances prescribed by regulation. (2) Despite subsection (1), a prescription for a monitored medicine that the regulations prescribe to be exempt from a recordable prescription is not a recordable prescription. (3) A recordable supply is a supply of a monitored medicine for administration to a person that: (a) occurs within the Territory; or (b) occurs outside the Territory if the supply is made to a person ordinarily resident in the Territory; or (c) occurs outside the Territory if the supply is made on the basis of a prescription issued in the Territory; or (d) is supplied in circumstances prescribed by regulation. (4) Despite subsection (3), a supply of a monitored medicine that the regulations prescribe to be exempt from a recordable supply is not a recordable supply. Division 2 Establishment and maintenance of monitored medicines database 243C Monitored medicines database to be kept (1) The CHO may establish and keep a database containing information about monitored medicines (the monitored medicines database) to be known by the name prescribed by regulation. (2) The purposes of the monitored medicines database are as follows: (a) to promote and protect public health and safety by ensuring that information is available to monitor the supply and sale of monitored medicines to a person; (b) to reduce harm from monitored medicines; (c) to facilitate evaluation and research into monitored medicines and the operation of the monitored medicines database. (3) The monitored medicines database must be kept electronically. -- 146 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 2 Establishment and maintenance of monitored medicines database Medicines, Poisons and Therapeutic Goods Act 2012 131 (4) The monitored medicines database may contain any of the following: (a) records received from a relevant prescriber, pharmacist, data source entity or another person or entity about recordable prescriptions or recordable supplies; (b) information relating to the issuing of authorities under the Act; (c) any other information prescribed by regulation. 243D Powers and functions of CHO in relation to database (1) The CHO may do any of the following in relation to the monitored medicines database: (a) collect and hold the information specified in section 243C(4) in the database; (b) access and use the database to: (i) correct an error or omission in the database; or (ii) change information held in the database to keep it accurate and up-to-date; or (iii) facilitate research into public health and the provision of health care; or (iv) administer, develop and operate the database; (c) disclose information held in the database: (i) to the person or entity responsible for keeping an equivalent database to the monitored medicines database under a corresponding law in a State or another Territory, if: (A) the State or other Territory has a regime for an equivalent database; and (B) the information only relates to monitored medicines, as defined by the corresponding law in the State or other Territory; and (C) the information relates to a recordable prescription or recordable supply; or (ii) for a purpose connected with the administration of this Part, including a legal or disciplinary proceeding arising out of the operation of this Part; or -- 147 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 2 Establishment and maintenance of monitored medicines database Medicines, Poisons and Therapeutic Goods Act 2012 132 (iii) to a health profession body; or (iv) to a law enforcement agency. (2) The CHO may do any thing or exercise any power reasonably necessary: (a) to implement, maintain and oversee the monitored medicines database; or (b) to further the purposes of the database. (3) The CHO may, by written notice, authorise a person or entity to exercise any of the CHO's powers or perform any of the CHO's functions specified in subsection (1). (4) An authorisation given under subsection (3) may be subject to any conditions the CHO considers appropriate. (5) In this section: health profession body means a National Health Practitioner Board established under the Health Practitioner Regulation National Law. health service provider, see section 5 of the Health Practitioner Regulation National Law. law enforcement agency, see section 4 of the Information Act 2002. 243E Persons required to give information to CHO (1) Subject to subsection (2), for the purposes of maintaining the monitored medicines database: (a) a relevant prescriber must, as soon as practicable after issuing a recordable prescription, give the prescribed information to the CHO in the manner or form the CHO considers appropriate; and (b) a pharmacist must, as soon as practicable after making a recordable supply, give the prescribed information to the CHO in the manner or form the CHO considers appropriate; and (c) a data source entity must, as soon as practicable after receiving information from a relevant prescriber or pharmacist about a recordable prescription or recordable supply, give the prescribed information to the CHO in the manner or form the CHO considers appropriate. -- 148 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 3 Access to monitored medicines database Medicines, Poisons and Therapeutic Goods Act 2012 133 (2) In addition, the CHO may require: (a) the relevant prescriber or pharmacist give the prescribed information specified in subsection (1)(a) or (b) to a data source entity; and (b) the data source entity give the prescribed information to the CHO in the manner or form the CHO considers appropriate. (3) The CHO may, by written notice, exempt a specified person from the requirement to give information under subsection (1). (4) The CHO may, by written notice published on the Agency's website, exempt a specified class of persons from the requirement to give information under subsection (1). Division 3 Access to monitored medicines database 243F Access for relevant prescribers and pharmacists (1) The CHO may, on application, authorise a person who is a relevant prescriber or pharmacist to access, use and disclose information held in the monitored medicines database for the following purposes in the performance of the person's duties as a relevant prescriber or pharmacist: (a) accessing records and information in relation to a person for whom a monitored medicine is intended to be supplied, prescribed or administered; (b) accessing records and information in relation to a person in relation to the medical treatment or care of that person; (c) disclosing information in relation to a person to a health practitioner if the relevant prescriber or pharmacist believes, on reasonable grounds, the practitioner intends to supply, prescribe or administer a monitored medicine to the person; (d) any other purpose prescribed by regulation. (2) An application for authorisation must be made in the approved form by the person. (3) The CHO may request further information from the person making the application. (4) The CHO must consider the application and decide whether to give the authorisation. -- 149 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 3 Access to monitored medicines database Medicines, Poisons and Therapeutic Goods Act 2012 134 (5) The CHO must give the person: (a) written notice of the CHO's decision; and (b) if the CHO refuses to give the authorisation – written notice of the reasons for the refusal. (6) An authorisation given under this section may be subject to any conditions the CHO considers appropriate. (7) The CHO may revoke an authorisation given under this section at any time by giving the person written notice of the revocation and the reasons for the revocation. Note for section 243F A relevant prescriber or pharmacist's access, use or disclosure of the information may be subject to guidelines made under section 243Q. 243G Access for other persons (1) The CHO may, by written notice published on the Agency's website, authorise a person or class of persons to access, use and disclose information held in the monitored medicines database for the following purposes: (a) the access, use and disclosure would assist in achieving the purposes of: (i) promoting safe supply, prescription and dispensing practices; and (ii) reducing harm from monitored medicines; (b) the access, use and disclosure is for technical or administrative purposes relating to the maintenance of the database; (c) the access, use and disclosure is to facilitate evaluation and research into monitored medicines and the operation of the monitored medicines database. (2) Before giving an authorisation under subsection (1), the CHO must be satisfied that the person or class of persons has appropriate arrangements for: (a) the security of the information; and (b) when the person or class of persons no longer requires the information – the destruction or disposal of the information. -- 150 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 4 Offences Medicines, Poisons and Therapeutic Goods Act 2012 135 (3) An authorisation given under subsection (1) may be subject to any conditions the CHO considers appropriate. (4) The CHO may revoke an authorisation given under subsection (1) at any time. Note for section 243G A person's access, use or disclosure of the information may be subject to guidelines made under section 243Q. Division 4 Offences 243H Person must not contravene requirement to give information (1) A person commits an offence if: (a) the person is required, under section 243E, to give information to the CHO in the manner or form the CHO considers appropriate; and (b) the person contravenes the requirement. Maximum penalty: 50 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the person has a reasonable excuse. 243J Relevant prescriber must check database before prescribing monitored medicine (1) A relevant prescriber commits an offence if: (a) the relevant prescriber issues a prescription for a monitored medicine to another person; and (b) the relevant prescriber does not check the information held in the monitored medicines database in relation to the other person before issuing the prescription; and (c) the prescription is not issued in circumstances that are prescribed by regulation to be exempt. Maximum penalty: 50 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the relevant prescriber has a reasonable excuse. -- 151 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 4 Offences Medicines, Poisons and Therapeutic Goods Act 2012 136 243K Pharmacist must check database before supplying monitored medicine (1) A pharmacist commits an offence if: (a) the pharmacist supplies a monitored medicine to another person; and (b) the pharmacist does not check the information held in the monitored medicines database in relation to the other person before supplying the monitored medicine; and (c) the supply is not made in circumstances that are prescribed by regulation to be exempt. Maximum penalty: 50 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the pharmacist has a reasonable excuse. 243L Unauthorised access, use or disclosure of information (1) A person commits an offence if: (a) the person is not authorised by or under this Act to access information held in the monitored medicines database; and (b) the person intentionally accesses information held in the monitored medicines database. Maximum penalty: 200 penalty units or imprisonment for 2 years. (2) A person commits an offence if: (a) the person is not authorised by or under this Act to use information held in the monitored medicines database; and (b) the person intentionally uses information held in the monitored medicines database. Maximum penalty: 200 penalty units or imprisonment for 2 years. (3) A person commits an offence if: (a) the person is not authorised by or under this Act to disclose information held in the monitored medicines database; and -- 152 of 187 -- Chapter 7 Administrative matters Part 7.1AA Monitored medicines database Division 5 Administrative matters Medicines, Poisons and Therapeutic Goods Act 2012 137 (b) the person intentionally discloses information held in the monitored medicines database. Maximum penalty: 200 penalty units or imprisonment for 2 years. (4) A person commits an offence if: (a) the person is authorised by or under this Act to access, use or disclose information held in the monitored medicines database; and (b) the person intentionally accesses, uses or discloses information held in the database; and (c) the access, use or disclosure results in the contravention of the authorisation or any conditions of the authorisation and the person is reckless in relation to that result. Maximum penalty: 200 penalty units or imprisonment for 2 years. (5) Strict liability applies to subsections (1)(a), (2)(a), (3)(a) and (4)(a). (6) It is a defence to a prosecution for an offence against subsection (4) if the person has a reasonable excuse. Division 5 Administrative matters 243M Protection from liability for duties and functions in relation to database (1) A relevant prescriber, pharmacist or person authorised under section 243G(1) is not liable for anything done in good faith in carrying out any duty in relation to, or in accessing, using or disclosing information held in, the monitored medicines database in accordance with this Act or the Regulations. (2) Without limiting subsection (1): (a) the accessing of information held in the monitored medicines database in respect of a person or the giving of information to the database in respect of a person does not constitute unprofessional conduct or a breach of professional etiquette or ethics; and (b) no liability for defamation is incurred by a person mentioned in subsection (1) because of the accessing of any person's information or the provision of that information. -- 153 of 187 -- Chapter 7 Administrative matters Part 7.1 Codes of practice Medicines, Poisons and Therapeutic Goods Act 2012 138 243N Data source entity The CHO may, by written notice published on the Agency's website, approve a person or entity to be a data source entity. 243P Sharing agreement The CHO may enter into an agreement or arrangement with the Commonwealth, a State or another Territory or an entity for the sharing of the information held in the monitored medicines database and any equivalent database maintained in a State or another Territory under a corresponding law. 243Q Guidelines (1) The CHO may make guidelines in relation to the access, use and disclosure of information held in the monitored medicines database under this Part. (2) The guidelines must be published on the Agency's website. Part 7.1 Codes of practice 244 CHO may make code of practice (1) The CHO may make a code of practice about a matter that is required or permitted by this Act to be prescribed by a code of practice in relation to a Schedule 8 substance or restricted Schedule 4 substance. Notes for subsection (1) 1 A contravention of a code of practice does not in itself constitute an offence against this Act. 2 However, if an authority is subject to the condition the holder of the authority comply must with a code of practice, the holder may commit an offence against section 147 for a failure to comply with the code of practice. In addition, a failure to comply with a code of practice may also be a ground for suspending or cancelling an authority under section 166. 3 Also, contravention of a code of practice by a health practitioner may constitute behaviour for which health, conduct or performance action may be taken under the Health Practitioner Regulation National Law. (2) The code of practice may apply, adopt or incorporate (with or without changes) a matter contained in another document or instrument as in force or existing at a particular time or from time to time. (3) Before making a code of practice, the CHO must consult with: (a) the Committee; and -- 154 of 187 -- Chapter 7 Administrative matters Part 7.2 CHO's powers and responsibilities Division 1 Exemptions, declarations and approvals for dealing with Scheduled substances Medicines, Poisons and Therapeutic Goods Act 2012 139 (b) each professional body representing health practitioners or veterinarians to whom the code of practice is to apply. (4) If the CHO makes a code of practice under this section, the CHO must publish on the Agency's website the code of practice and notice of its making. (5) The code of practice has no effect until publication of the notice. Part 7.2 CHO's powers and responsibilities Division 1 Exemptions, declarations and approvals for dealing with Scheduled substances 245 Exemption from holding Schedule 8 authorisation (1) The CHO may exempt an authorised health practitioner from the requirement to hold a Schedule 8 authorisation for dealing with: (a) a restricted Schedule 8 substance for an authorised purpose; or (b) an unrestricted Schedule 8 substance in a prohibited circumstance. (2) Before doing so, the CHO must ask the Committee for its advice on the proposed exemption. (3) The CHO may give the exemption only after considering the Committee's advice. (4) The exemption must be given: (a) for an exemption for a particular authorised health practitioner – by written notice to the authorised health practitioner; or (b) for an exemption for a class of authorised health practitioners – by notice published on the Agency's website. (5) The CHO may give the exemption subject to conditions. (6) An authorised health practitioner must not engage in conduct that results in a contravention of a condition of the exemption. Maximum penalty for subsection (6): 200 penalty units or imprisonment for 2 years. -- 155 of 187 -- Chapter 7 Administrative matters Part 7.2 CHO's powers and responsibilities Division 1 Exemptions, declarations and approvals for dealing with Scheduled substances Medicines, Poisons and Therapeutic Goods Act 2012 140 246 Restricted Schedule 4 and 8 substances (1) The CHO may, by notice published on the Agency's website, declare: (a) a Schedule 4 substance to be a restricted Schedule 4 substance; or (b) a Schedule 8 substance to be a restricted Schedule 8 substance. (2) Before doing so, the CHO must ask the Committee for its advice on the proposed declaration. (3) The CHO may make the declaration only after considering the Committee's advice on the proposed declaration. (4) For a restricted Schedule 4 substance, the declaration must state the conditions applying to the issue of a prescription for the supply of, or the supply or administration of, the substance. (5) Subject to subsection (4), the conditions stated in the declaration in relation to the substance are in addition to any control in relation to the substance in Appendix D to the medicines and poisons standard. (6) The declaration prevails to the extent of any inconsistency between: (a) a condition stated in the declaration; and (b) a provision of this Act or any control in relation to the substance in Appendix D to the medicines and poisons standard. 251 Emergency authorisation for possessing, supplying and administering Schedule 3, 4 and 8 substances (1) The CHO may, by notice published on the Agency's website, authorise a person, or a class of health practitioners, to possess, supply or administer stated Schedule 3, 4 or 8 substances in an emergency relating to public health (an emergency authorisation). (2) To avoid doubt, the emergency authorisation may be made even if no declaration of a public health emergency is in force under the Public and Environmental Health Act 2011. -- 156 of 187 -- Chapter 7 Administrative matters Part 7.2 CHO's powers and responsibilities Division 1 Exemptions, declarations and approvals for dealing with Scheduled substances Medicines, Poisons and Therapeutic Goods Act 2012 141 (3) However, the CHO may make the emergency authorisation for a person who is not a health practitioner only if the CHO considers the person is appropriately qualified to possess, supply or administer the Scheduled substances. (4) The emergency authorisation: (a) commences on the date the notice is given and ends on the date (not longer than 2 years after that date) stated in the notice; and (b) must include the following particulars: (i) a description of the public health emergency to which it relates; (ii) the clinical circumstances in which the substances may be possessed, supplied or administered; (iii) the persons to whom the substances may be supplied or administered; (iv) other particulars about the form, strength, dosage and frequency of administration of the substances the CHO considers appropriate; and (c) is subject to the conditions stated in the notice. 252 Declared places The CHO may, by notice published on the Agency's website, declare a health centre or clinic to be a place to which Part 2.6 applies. Example of declared place A health clinic at a custodial correctional facility as defined in section 11(1)(a) of the Correctional Services Act 2014. 253 Approval for pharmacist to supply Schedule 8 substance or restricted Schedule 4 substances on interstate prescription (1) The CHO may, by notice published on the Agency's website, approve a pharmacist supplying a Schedule 8 substance or restricted Schedule 4 substance to persons living in a stated area or community on the prescription of an interstate prescriber for the substance. -- 157 of 187 -- Chapter 7 Administrative matters Part 7.2 CHO's powers and responsibilities Division 2 Register of authorities and information availability Medicines, Poisons and Therapeutic Goods Act 2012 142 (2) The CHO may give the approval for a substance only if satisfied the persons would not otherwise be able to readily obtain the substance because of the remoteness of the area or community. (3) The CHO may give the approval subject to conditions. (4) A pharmacist must not engage in conduct that results in a contravention of a condition of the approval. Maximum penalty: 200 penalty units or imprisonment for 2 years. 254 Approval of SSTP (1) The CHO may approve, in writing, an SSTP if the CHO considers: (a) the SSTP contains adequate information to satisfy the requirements specified in section 70B(2); and (b) having regard to the matters to which the SSTP relates, it is appropriate to do so. (2) The approval of an SSTP takes effect: (a) on the date it is approved; or (b) if the CHO specifies a later effective date in the approval of the SSTP – the later date. (3) The approval of an SSTP remains in effect until the expiry of the period, not exceeding 2 years, specified by the CHO in the approval, unless it is sooner revoked. (4) An SSTP approved under subsection (1) and the CHO's written approval of it must be published on the Agency's website as soon as practicable after the SSTP has been approved. (5) The CHO may revoke, in writing, the approval of an SSTP. Division 2 Register of authorities and information availability 255 Register of authorities (1) The CHO must keep a register of each type of authority. (2) The register may be in any form, including an electronic form. (3) The register must contain the particulars prescribed by regulation. -- 158 of 187 -- Chapter 7 Administrative matters Part 7.2 CHO's powers and responsibilities Division 3 Other administrative powers Medicines, Poisons and Therapeutic Goods Act 2012 143 256 Public access to some registers (1) Anyone may inspect the register for the following authorities during the Agency's normal business hours: (a) certificates of registration; (b) retailer licences; (c) pest management technician licences. (2) The CHO may give a person a copy or summary of particulars in the register. (3) However, other registers are not open for inspection by members of the public. Division 3 Other administrative powers 257 Information relating to supply and use of substances (1) The CHO may, by notice published on the Agency's website, authorise any of the following persons to be given, or disclose, substance information: (a) a public sector employee; (b) another person the CHO is satisfied is employed in a capacity requiring access to substance information. (2) In this section: substance information means information relating to the supply or administration of a Scheduled substance to a particular person. 258 Approved forms The CHO may approve forms for this Act. 259 Delegation by CHO (1) The CHO may delegate any of the CHO's powers and functions under this Act to any of the following: (a) an authorised officer; (b) a public sector employee engaged in the Agency; (c) a health practitioner. -- 159 of 187 -- Chapter 7 Administrative matters Part 7.3 Scheduled Substances Clinical Advisory Committee Division 1 Establishment, functions and powers Medicines, Poisons and Therapeutic Goods Act 2012 144 (2) However, the CHO cannot delegate a power or function in relation to the reconsideration of an original decision under Chapter 5. (3) Also, the CHO may delegate a power or function to a person only if satisfied the person has appropriate qualifications or experience for the delegation. Part 7.3 Scheduled Substances Clinical Advisory Committee Division 1 Establishment, functions and powers 260 Establishment The Scheduled Substances Clinical Advisory Committee is established. 261 Functions (1) The Committee's function is to give advice and make recommendations on issues relating to dealing with Scheduled substances. (2) Without limiting subsection (1), the Committee has the following functions: (a) to advise the CHO about the competency required by doctors to supply Scheduled substances; (b) to recommend to the CHO appropriate training programs for doctors who supply Scheduled substances; (c) to advise the CHO about the treatment of persons (whether generally or a particular person) with Scheduled substances; (d) to advise the CHO about issuing, varying, suspending and cancelling Schedule 4 or 8 authorisations for Scheduled substances; (e) to make recommendations to the CHO about matters to be included in codes of practice; (f) to advise the CHO about whether matters relating to the supply of a Scheduled substance should be referred to a National Health Practitioner Board established under the Health Practitioner Regulation National Law; -- 160 of 187 -- Chapter 7 Administrative matters Part 7.3 Scheduled Substances Clinical Advisory Committee Division 2 Provisions about membership Medicines, Poisons and Therapeutic Goods Act 2012 145 (g) to advise the CHO about policy issues relating to the issue of prescriptions for the supply of, or the supply or use of, Scheduled substances; (h) to give other advice about Scheduled substances as conferred on it under this or another Act. (3) In this section: Scheduled substance means: (a) a restricted Schedule 4 substance; or (b) a Schedule 8 substance. 262 Powers The Committee has the powers necessary to perform its functions. 263 Delegation (1) The Committee may delegate any of its powers or functions to the chairperson or an authorised officer. (2) The delegation must be signed by a majority of Committee members. Division 2 Provisions about membership 264 Membership (1) The Committee consists of the following: (a) at least 6 members appointed by the CHO (appointed members); (b) an authorised officer nominated by the CHO. (2) An appointed member may be reappointed. 265 Qualifications and nominations for appointment An appointed member must be qualified or nominated for appointment as prescribed by regulation. 266 Duration of appointment An appointed member holds office for the period, not exceeding 3 years, stated in the instrument of appointment. -- 161 of 187 -- Chapter 7 Administrative matters Part 7.3 Scheduled Substances Clinical Advisory Committee Division 2 Provisions about membership Medicines, Poisons and Therapeutic Goods Act 2012 146 267 Conditions of appointment An appointed member holds office on the conditions stated in the instrument of appointment. 268 Chairperson and deputy chairperson (1) The chairperson of the Committee is: (a) the member appointed by the CHO to be the chairperson; or (b) if the CHO does not appoint the chairperson – the member appointed by the Committee. (2) The Committee must appoint a member, other than the chairperson, as deputy chairperson of the Committee. (3) The deputy chairperson must act in the office of chairperson during any period when the chairperson: (a) is absent from the Territory; or (b) is unable for any reason to perform the duties of office. 269 When member ceases to hold office (1) An appointed member ceases to hold office if: (a) the member resigns by giving written notice of resignation to the CHO; or (b) the member's term of office comes to an end and the member is not reappointed; or (c) the member is convicted of an indictable offence or sentenced to imprisonment for an offence; or (d) the member is absent, except on leave granted by the Committee, from 3 consecutive meetings of the Committee; or (e) the member is removed from office under subsection (2). (2) The CHO may remove an appointed member from office for: (a) mental or physical incapacity to perform the duties of office satisfactorily; or (b) neglect of duty; or (c) breach of a condition of appointment; or -- 162 of 187 -- Chapter 7 Administrative matters Part 7.3 Scheduled Substances Clinical Advisory Committee Division 3 Conduct of business Medicines, Poisons and Therapeutic Goods Act 2012 147 (d) dishonest or dishonourable conduct. Division 3 Conduct of business 270 Meetings (1) The Committee must meet as often as is necessary for the exercise of its powers and the performance of its functions. (2) However, the Committee must meet at least twice in each year. 271 Presiding member at meetings The chairperson must preside at all meetings of the Committee at which he or she is present. 272 Procedure at meetings (1) A quorum of the Committee consists of the chairperson and at least one third of the other members in office. (2) A question arising for decision at a Committee meeting must be resolved according to the opinion of a majority of the members present at the meeting and, if they are equally divided in opinion, the chairperson has a casting vote. (3) The Committee must keep proper minutes of its proceedings and decisions. (4) Subject to this Division, the Committee may decide its own procedures. 273 Disclosure of interest (1) If a member of the Committee has a direct or indirect interest in a matter being considered or about to be considered by the Committee, the member must disclose the nature of the interest at a Committee meeting as soon as practicable after the relevant facts come to the member's knowledge. (2) The disclosure must be recorded in the Committee's minutes. (3) The member must not, while having that interest: (a) take part in any deliberation or decision of the Committee relating to that matter; or (b) form part of the quorum of the Committee in any deliberation or decision of the Committee relating to that matter. -- 163 of 187 -- Chapter 7 Administrative matters Part 7.4 Authorised officers Medicines, Poisons and Therapeutic Goods Act 2012 148 (4) However, subsection (3) does not apply to the member if the Committee resolves the subsection does not so apply. (5) Despite the resolution, the member may refuse to take part in any deliberation or decision of the Committee relating to the matter. Part 7.4 Authorised officers 274 Who is authorised officer (1) An authorised officer is: (a) the CHO; or (b) a person appointed under subsection (2) as an authorised officer; or (c) a police officer of or above the rank of sergeant. (2) The CHO may appoint as an authorised officer: (a) a public sector employee engaged in the Agency; or (b) a public sector employee engaged in another Agency under an arrangement with the Chief Executive Officer of that Agency; or (c) another person if: (i) the CHO is satisfied the person has appropriate qualifications or experience to exercise powers and perform functions of an authorised officer; and (ii) the person agrees to the appointment. (3) The CHO has all the powers and functions of an authorised officer. (4) An authorised officer appointed under subsection (2) has the powers and functions of an authorised officer stated in the appointment. (5) A police officer mentioned in subsection (1)(c) has all the powers and functions of an authorised officer. 275 Identity cards (1) The CHO must give each authorised officer (other than a police officer) an identity card stating the person's name and that the person is an authorised officer. -- 164 of 187 -- Chapter 7 Administrative matters Part 7.4 Authorised officers Medicines, Poisons and Therapeutic Goods Act 2012 149 (2) The identity card must: (a) show a recent photograph of the officer; and (b) state the card's date of expiry. (3) This section does not prevent the issue of a single identity card to a person for this and another Act. 276 Production of identity card An authorised officer (other than a police officer in uniform) exercising a power or performing a function under this Act in relation to a person must, if asked by the person, produce for the person's inspection: (a) for an authorised officer who is a police officer – the officer's police identification; or (b) for another authorised officer – the officer's identity card. 277 Return of identity card (1) A person who ceases to be an authorised officer (other than a police officer) must return the person's identity card to the CHO within 21 days after the cessation. Maximum penalty: 20 penalty units. (2) An offence against subsection (1) is an offence of strict liability. (3) It is a defence to a prosecution for an offence against subsection (1) if the person establishes a reasonable excuse. -- 165 of 187 -- Chapter 8 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 150 Chapter 8 Miscellaneous matters 278 Acquisition on just terms If the operation of this Act would, apart from this section, result in an acquisition of property from a person otherwise than on just terms: (a) the person is entitled to receive from the Territory the compensation necessary to ensure the acquisition is on just terms; and (b) a court of competent jurisdiction may decide the amount of compensation or make the orders it considers necessary to ensure the acquisition is on just terms. 279 Protection of health practitioners and veterinarians from liability (1) This section applies if: (a) a health practitioner or veterinarian: (i) gives notice to the CHO about the supply of a Scheduled substance as required under this Act; or (ii) applies for a Schedule 4 or 8 authorisation or prohibited substance authorisation; and (b) in good faith, the health practitioner or veterinarian discloses private or confidential information about a person in giving the notice or making the application. (2) The health practitioner or veterinarian is not civilly or criminally liable for the disclosure. (3) Without limiting subsection (2), making the disclosure does not constitute a breach of professional etiquette or ethics or a departure from accepted standards of professional conduct. 280 Protection of persons administering Act from liability (1) A person is not civilly or criminally liable for an act done or omitted to be done by the person in good faith in the exercise of a power or performance of a function as any of the following: (a) a member of the Committee; (b) an authorised officer; -- 166 of 187 -- Chapter 8 Miscellaneous matters Medicines, Poisons and Therapeutic Goods Act 2012 151 (c) a person assisting an authorised officer under Chapter 4. (2) Subsection (1) does not affect any liability the Territory would, apart from that subsection, have for the act or omission. (3) In this section: exercise, of a power, includes the purported exercise of the power. performance, of a function, includes the purported performance of the function. 281 Regulations (1) The Administrator may make regulations under this Act. (2) A regulation may provide for any the following: (a) holders of authorities and others dealing with Scheduled substances, including authorising others to deal with Scheduled substances; (ab) storage, transport and destruction of Scheduled substances; (b) keeping of records by holders of authorities and others dealing with Scheduled substances; (c) reporting requirements of holders of authorities and others dealing with Scheduled substances; (d) applying, adopting or incorporating (with or without changes) the whole or part of a document as in force or existing at a particular time or from time to time; (e) exempting a person, place, Scheduled substance, dealing with a Scheduled substance or other activity from the application of this Act, or a provision of this Act, either conditionally or unconditionally; (f) prescribing fees payable under this Act; (g) an offence against a regulation to be an offence of strict or absolute liability. (3) A regulation may authorise a matter to be decided, applied or regulated by the CHO (whether or not from time to time). -- 167 of 187 -- Chapter 8 Miscellaneous matters Part 9.2 Transitional matters for Medicines, Poisons and Therapeutic Goods Act 2012 Medicines, Poisons and Therapeutic Goods Act 2012 152 Chapter 9 Repeals and transitional matters Part 9.1 Repeal of Acts 282 Repeals The Acts mentioned in Schedule 3 are repealed. Part 9.2 Transitional matters for Medicines, Poisons and Therapeutic Goods Act 2012 283 Definitions In this Part: commencement day means the day on which section 282 commences. corresponding authority, for an old authority, means the type of authority under this Act that authorises its holder to deal with a Scheduled substance in the same way as the old authority. Examples 1 The corresponding authority for an authorisation under section 28(6) of the repealed Act for possessing and using a Schedule 8 substance is a Schedule 8 authorisation for possessing and using the substance. 2 The corresponding authority for an authorisation issued under section 31G of the repealed Act for supplying a restricted Schedule 8 substance is a Schedule 8 authorisation for supplying the substance. 3 The corresponding authority for an authorisation under section 78 of the repealed Act is: (a) for manufacturing the substance – a manufacturer certificate of registration for the substance; or (b) for using the substance for research purposes – a research authorisation for the substance; or (c) for administering the substance – a prohibited substance authorisation for administering the substance. old authority means: (a) a certificate of registration of premises under Part II of the repealed Act for manufacturing a poison; or (b) a certificate of registration of premises under Part III of the repealed Act for storage for wholesale supplying a poison; or -- 168 of 187 -- Chapter 8 Miscellaneous matters Part 9.2 Transitional matters for Medicines, Poisons and Therapeutic Goods Act 2012 Medicines, Poisons and Therapeutic Goods Act 2012 153 (c) a licence under Part IV of the repealed Act for supplying a poison by retail; or (d) an authorisation under section 28(6) of the repealed Act for obtaining, possessing and using a Schedule 4 or 8 substance; or (e) an authorisation under Part VA, Division 3, of the repealed Act for the supply, as defined for that Part, under section 31F of a non-restricted Schedule 8 substance; or (f) an authorisation under Part VA, Division 3, of the repealed Act for the supply, as defined for that Part, under section 31G of a restricted Schedule 8 substance; or (g) an authorisation under Part VIII of the repealed Act for possessing and administering a Schedule 4 or 8 substance; or (h) an authorisation under section 53 of the repealed Act for possessing and using a Schedule 7 substance; or (i) a pest control operator licence under Part XI of the repealed Act for possessing and using a pesticide; or (j) an authorisation under section 78 of the repealed Act for possessing, producing, preparing, manufacturing, supplying, administering or using the prohibited substance mentioned in that section. repealed Act means the Poisons and Dangerous Drugs Act 1983 as in force immediately before the commencement day. 284 Prescriptions and directions for dealing with Scheduled substances (1) Subsection (2) applies to a prescription: (a) issued under the repealed Act for the supply of a Schedule 4 or 8 substance; and (b) that would have remained in force on the commencement day had the repealed Act not been repealed. (2) The prescription: (a) is taken to have been issued under this Act; and (b) continues in force until it would have ended had the repealed Act not been repealed. -- 169 of 187 -- Chapter 8 Miscellaneous matters Part 9.2 Transitional matters for Medicines, Poisons and Therapeutic Goods Act 2012 Medicines, Poisons and Therapeutic Goods Act 2012 154 (3) Subsection (4) applies to a direction: (a) given under section 39(4) of the repealed Act for the administration of a Schedule 4 or 8 substance; and (b) that would be in force on the commencement day had the repealed Act not been repealed. (4) The direction: (a) is taken to be a supply order for the substance; and (b) continues in force until it would have ended had the repealed Act not been repealed. 285 Old authority (1) An old authority in force immediately before the commencement day is taken to be the corresponding authority for it under this Act. (2) Subsection (1) applies even if the CHO had suspended the old authority under the repealed Act. (3) For subsection (1), a certificate of registration of premises under the repealed Act is taken to have been issued to the person carrying out the activity to which the certificate relates. (4) The corresponding authority has effect subject to the conditions applying to it under Part 3.2, Division 3. (5) In addition, subject to subsection (4), the conditions applying to the old authority immediately before the commencement day continue to apply to the corresponding authority. (6) The corresponding authority ends when the old authority would have ended had the repealed Act not been repealed. 286 Pending application relating to authority (1) This section applies to an application made under the repealed Act for, or the renewal or transfer of, an old authority that had not been decided before the commencement day (the pending application). (2) The pending application must be treated as if it were an application under this Act for, or the renewal or transfer of, the corresponding authority for the old authority. (3) For subsection (2), an application relating to a certificate of registration of premises is taken to have been made by the person carrying out the activity to which the certificate relates. -- 170 of 187 -- Chapter 8 Miscellaneous matters Part 9.2 Transitional matters for Medicines, Poisons and Therapeutic Goods Act 2012 Medicines, Poisons and Therapeutic Goods Act 2012 155 287 Pending action to vary, suspend or revoke authorisation (1) This section applies if: (a) the CHO had given notice under section 31J of the repealed Act to a doctor stating proposed action in relation to an authorisation held by the doctor; and (b) immediately before the commencement day, the action had not been finalised. (2) The CHO must decide whether to take action under that section as if the repealed Act had not been repealed. (3) However, if the CHO decides to vary, suspend or cancel the authorisation, the decision is taken to be an original decision to vary, suspend or cancel the authorisation under Part 3.5 or 3.6. Note for section 287 Under section 284, the authorisation is taken to be a Schedule 8 authorisation. 288 Suspended authorisation (1) This section applies if, before the commencement day, the CHO had: (a) under section 31J of the repealed Act, suspended an authorisation under Part VA, Division 3 of the repealed Act; or (b) under section 59 of the repealed Act, suspended an authorisation or pest control operator licence under Part XI of the repealed Act. (2) The suspension ends on the date it would have ended had the repealed Act not been repealed. 289 Provisions relating to employment involving pesticides (1) A requirement made under section 59(1) of the repealed Act to undergo a medical examination is taken to be a notice given under section 172(2). (2) An order under section 59(1)(f) of the repealed Act is taken to be an order under section 172(4)(c). -- 171 of 187 -- Chapter 8 Miscellaneous matters Part 9.2 Transitional matters for Medicines, Poisons and Therapeutic Goods Act 2012 Medicines, Poisons and Therapeutic Goods Act 2012 156 290 Directions under section 30 of repealed Act (1) This section applies if: (a) under section 30 of the repealed Act, the CHO directed a pharmacist not to hold a Schedule 8 substance on premises stated in the direction; and (b) had the repealed Act not been repealed, the direction would be in force on the commencement day. (2) The direction has effect as if it were a prohibition notice issued under section 116(2) and continues in force until it would have ended had the repealed Act not been repealed. 291 Prohibitions under sections 31 and 31N of repealed Act (1) Subsections (2) and (3) apply if: (a) under section 31(1) or 31N(1) of the repealed Act, the CHO gave notice to a dentist, veterinarian or doctor proposing the dentist, veterinarian or doctor be prohibited from possessing, supplying, administering or prescribing a Schedule 8 substance; and (b) the period stated in the notice for making submissions on the proposed prohibition had not ended. (2) The CHO must decide the matter under the repealed Act as if it had not been repealed. (3) If the CHO gives a notice under section 31(2) or 31N(2) of the repealed Act prohibiting the dentist, veterinarian or doctor from possessing, supplying, administering or prescribing a Schedule 8 substance, the notice is taken to be a prohibition notice given under section 116(2). (4) Subsection (5) applies if: (a) before the commencement day, the CHO gave notice under section 31(2) or 31N(2) of the repealed Act to a dentist, veterinarian or doctor prohibiting the dentist, veterinarian or doctor from possessing, supplying, administering or prescribing a Schedule 8 substance; and (b) had the repealed Act not been repealed, the prohibition would be in force on the commencement day. -- 172 of 187 -- Chapter 8 Miscellaneous matters Part 9.3 Transitional matters for Statute Law Amendment (Directors' Liability) Act 2015 Medicines, Poisons and Therapeutic Goods Act 2012 157 (5) The notice has effect as if it were a prohibition notice issued under section 116(2) and continues in force until it would have ended had the repealed Act not been repealed. 292 Registers of manufacturer and wholesaler premises (1) This section applies to the following registers kept by the CHO under the repealed Act: (a) the register of premises registered under Part II of the repealed Act (the Part 2 register); (b) the register of premises registered under Part III of the repealed Act (the Part 3 register). (2) For section 255: (a) the Part 2 register is taken to be the register of manufacturer certificates of registration; and (b) the Part 3 register is taken to be the register of wholesaler certificates of registration. 293 Interpretation Act not affected This Part does not limit Part III of the Interpretation Act 1978. Part 9.3 Transitional matters for Statute Law Amendment (Directors' Liability) Act 2015 295 Offences – before and after commencement (1) Section 215, as amended by the Statute Law Amendment (Directors' Liability) Act 2015, (the new section) applies in relation to a relevant offence committed by a body corporate after the commencement of Part 2, Division 23 of that Act (the commencement) only if: (a) all the conduct constituting the relevant offence occurred after the commencement; and (b) all the conduct of the executive officer constituting the offence against the new section occurred after the commencement. (2) Section 215, as in force before the commencement: (a) continues to apply in relation to offences committed by a body corporate before the commencement; and -- 173 of 187 -- Chapter 8 Miscellaneous matters Part 9.4 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2021 Medicines, Poisons and Therapeutic Goods Act 2012 158 (b) applies in relation to relevant offences committed by a body corporate after the commencement to which, as a result of subsection (1), the new section does not apply. Part 9.4 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2021 296 Definitions In this Part: amending Act means the Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2021. commencement means the day on which section 8 of the amending Act commences. 297 Information obtained before commencement (1) This section applies in relation to information obtained under section 96 or 139 before the commencement that, if obtained after the commencement, would be information required to be given to the CHO under Chapter 7, Part 7.1AA. (2) The information is taken to be information obtained under Chapter 7, Part 7.1AA after the commencement. 298 Offences – before and after commencement (1) Section 207, as inserted by the amending Act, applies only in relation to an offence committed after the commencement. (2) Section 207, as in force before the commencement, continues to apply in relation to an offence committed before the commencement. (3) For this section, if any of the conduct constituting an offence occurred before the commencement, the offence is taken to have been committed before the commencement. -- 174 of 187 -- Chapter 8 Miscellaneous matters Part 9.5 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 Medicines, Poisons and Therapeutic Goods Act 2012 159 Part 9.5 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 299 Definitions In this Part: amending Act means the Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022. commencement means the commencement of section 3 of the amending Act. COVID-19 vaccine means a Scheduled substance for vaccination against the Coronavirus disease named "COVID-19" by the World Health Organization. former CVAP means a COVID-19 vaccine administration protocol that was approved under section 254B(1), as in force immediately before the commencement. former SSTP means a Scheduled substance treatment protocol that was approved under section 254(1), as in force immediately before the commencement. 300 Scheduled substance treatment protocols approved before commencement (1) For sections 301 and 302, a former SSTP continues in force after the commencement until the earlier of the following: (a) the approval of the former SSTP is revoked by the CHO under subsection (2); (b) the day that is 2 years after the commencement. (2) The CHO may revoke, in writing, the approval of a former SSTP that continues to remain in force under subsection (1). 301 Transitional authority for health practitioners approved to administer Schedule 4 or 8 substance before commencement (1) This section applies to an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a paramedic who was declared by Gazette notice under section 250, as in force immediately before the commencement, to be approved to administer a Schedule 4 or 8 substance stated in the notice in accordance with the former SSTP stated in the notice (an -- 175 of 187 -- Chapter 8 Miscellaneous matters Part 9.5 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 Medicines, Poisons and Therapeutic Goods Act 2012 160 approved practitioner). (2) Subject to subsection (3), an approved practitioner may, in the course of practising in the approved practitioner's health profession, administer the substance to another person after the commencement if the former SSTP stated in the notice for the approved practitioner continues to remain in force under section 300 at the time of the administration of the substance. (3) The approved practitioner must administer the substance in accordance with: (a) the former SSTP; and (b) any conditions or limitations that were specified in the notice for the approved practitioner. (4) An approved practitioner who is authorised to administer a Schedule 4 or 8 substance under subsection (2) may, in the course of practising in the approved practitioner's health profession, possess the substance for that purpose after the commencement. 302 Transitional authority for health practitioners approved to supply Schedule 4 or 8 substance before commencement (1) This section applies to an Aboriginal and Torres Strait Islander health practitioner, a nurse or a midwife who was declared by Gazette notice under section 250, as in force immediately before the commencement, to be approved to supply a Schedule 4 or 8 substance stated in the notice in accordance with the former SSTP stated in the notice (an approved practitioner). (2) Subject to subsection (3), an approved practitioner may, in the course of practising in the approved practitioner's health profession, supply the substance to another person after the commencement if the former SSTP stated in the notice for the approved practitioner continues to remain in force under section 300 at the time of the supply of the substance. (3) The approved practitioner must supply the substance in accordance with: (a) the former SSTP; and (b) any conditions or limitations that were specified in the notice for the approved practitioner. (4) An approved practitioner who is authorised to supply a Schedule 4 or 8 substance under subsection (2) may, in the course of -- 176 of 187 -- Chapter 8 Miscellaneous matters Part 9.5 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 Medicines, Poisons and Therapeutic Goods Act 2012 161 practising in the approved practitioner's health profession, possess the substance for that purpose after the commencement. 303 COVID-19 vaccine administration protocols approved before commencement (1) A former CVAP continues in force after the commencement until the earlier of the following: (a) the approval of the former CVAP is revoked by the CHO under subsection (2); (b) the effective period that was specified in the former CVAP expires; (c) the day that is 2 years after the commencement. (2) The CHO may revoke, in writing, the approval of a former CVAP that remains in force under subsection (1). 304 Transitional authority for persons authorised to deal with COVID-19 vaccine before commencement (1) This section applies to a person who was authorised under section 254C(1), as in force immediately before the commencement, to possess, supply or administer a COVID-19 vaccine in accordance with the former CVAP specified in the person's authorisation (an approved person). (2) Subject to subsection (3), an approved person continues to be authorised after the commencement to possess, supply or administer a COVID-19 vaccine in accordance with the former CVAP while it continues to remain in force under section 303. (3) An approved person who possesses, supplies or administers a COVID-19 vaccine under subsection (2) must comply with the person's authorisation under the former CVAP. 305 Supply of Schedule 3 substances – authorities issued before commencement A person who is authorised to administer a Schedule 3 substance to another person under a medical kit authorisation or a research authorisation that is in force immediately before the commencement is authorised to supply, but not to sell, the substance under that authority after the commencement. -- 177 of 187 -- Chapter 8 Miscellaneous matters Part 9.5 Transitional matters for Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 Medicines, Poisons and Therapeutic Goods Act 2012 162 306 Declared places A declaration made under section 252 that is in force immediately before the commencement continues in force after the commencement as if it were published on the Agency's website. 307 Offence provisions – before and after commencement (1) Sections 37, 38, 100, 112B and 112C, as inserted by the amending Act, apply only in relation to offences committed after the commencement. (2) Sections 37, 38 and 100, as in force before the commencement, continue to apply in relation to offences committed before the commencement. (3) For this section, if any of the conduct constituting an offence occurred before the commencement, the offence is taken to have been committed before the commencement. -- 178 of 187 -- Schedule 1 Declared provisions Medicines, Poisons and Therapeutic Goods Act 2012 163 Schedule 1 Declared provisions section 212 definition declared provision Part 2.2, other than sections 44(1) and 48(1) Part 2.7, other than sections 107, 108 and 114(1) Sections 147, 165(1) and 170(1) Part 3.7, other than section 172(3) Sections 190(3), 202(1), 203(2) and 205(4) Part 4.6, other than section 210(1) -- 179 of 187 -- Schedule 2 Original decisions and affected persons Medicines, Poisons and Therapeutic Goods Act 2012 164 Schedule 2 Original decisions and affected persons section 220 Original decision Affected person Notice prohibiting authorised health practitioner or veterinarian dealing with Schedule 8 substance (section 116(2)) Person who receives notice Refusing to issue authority (section 134(3) or (4)) Applicant Imposing conditions on authority (section 143(2)) Holder of authority Refusing to renew authority (section 134(3) or (4)) as applied by section 152(2)) Holder of authority Refusing to transfer certificate of registration (section 134(3) as applied by section 154(2)) Holder of authority Varying conditions of authority (section 157) Holder of authority Refusing to vary conditions of authority (section 160) Holder of authority Suspending or cancelling authority (section 169(2) or 171(2)) Holder of authority Notice to cease employment involving Schedule 7 substances or pesticides (section 172(4)(d)) Employer and employee to whom notice relates Amount of compensation for forfeited thing (section 200) Applicant Giving compliance notice (section 201) Person who receives notice Refusing to give authorisation (section 243F(5)) Person who receives notice Revocation of authorisation (section 243F(7)) Person who receives notice -- 180 of 187 -- Schedule 3 Repealed Acts Medicines, Poisons and Therapeutic Goods Act 2012 165 Schedule 3 Repealed Acts section 282 Poisons and Dangerous Drugs Act 1983 Act No. 4 of 1983 Poisons and Dangerous Drugs (Criminal Code) Amendment Act 1983 Act No. 67 of 1983 Poisons and Dangerous Drugs Amendment Act 1985 Act No. 75 of 1985 Poisons and Dangerous Drugs Amendment Act 1987 Act No. 29, 1987 Poisons and Dangerous Drugs Amendment Act 1989 Act No. 28, 1989 Poisons and Dangerous Drugs Amendment Act 1990 Act No. 18, 1990 Poisons and Dangerous Drugs Amendment Act 1995 Act No. 33, 1995 Poisons and Dangerous Drugs Amendment Act (No. 2) 1995 Act No. 58, 1995 Poisons and Dangerous Drugs Amendment Act 2003 Act No. 52, 2003 Poisons and Dangerous Drugs Amendment Act 2004 Act No. 61, 2004 Poisons and Dangerous Drugs Amendment Act 2006 Act No. 37, 2006 Therapeutic Goods and Cosmetics Act 1986 Act No. 46 of 1986 -- 181 of 187 -- ENDNOTES Medicines, Poisons and Therapeutic Goods Act 2012 166 ENDNOTES 1 KEY Key to abbreviations amd = amended od = order app = appendix om = omitted bl = by-law pt = Part ch = Chapter r = regulation/rule cl = clause rem = remainder div = Division renum = renumbered exp = expires/expired rep = repealed f = forms s = section Gaz = Gazette sch = Schedule hdg = heading sdiv = Subdivision ins = inserted SL = Subordinate Legislation lt = long title sub = substituted nc = not commenced 2 LIST OF LEGISLATION Medicines, Poisons and Therapeutic Goods Act 2012 (Act No. 13, 2012) Assent date 27 April 2012 Commenced 1 May 2014 (Gaz S22, 30 April 2014, p 12) Medicines, Poisons and Therapeutic Goods Amendment Act 2014 (Act No. 12, 2014) Assent date 16 April 2014 Commenced 16 April 2014 Correctional Services (Related and Consequential Amendments) Act 2014 (Act No. 27, 2014) Assent date 4 September 2014 Commenced 9 September 2014 (Gaz S80, 9 September 2014, p 2) Statute Law Amendment (Directors' Liability) Act 2015 (Act No. 26, 2015) Assent date 18 September 2015 Commenced 14 October 2015 (Gaz G41, 14 October 2015, p 3) Local Court (Related Amendments) Act 2016 (Act No. 8, 2016) Assent date 6 April 2016 Commenced 1 May 2016 (s 2, s 2 Local Court (Repeals and Related Amendments) Act 2016 (Act No. 9, 2016) and Gaz S34, 29 April 2016) Justice Legislation Amendment (Drug Offences) Act 2016 (Act No. 17, 2016) Assent date 8 June 2016 Commenced s 17 (to ext ins new s 15): 10 October 2016; rem: 18 July 2016 (Gaz S67, 18 July 2016) Statute Law Revision Act 2017 (Act No. 4, 2017) Assent date 10 March 2017 Commenced 12 April 2017 (Gaz G15, 12 April 2017, p 3) -- 182 of 187 -- ENDNOTES Medicines, Poisons and Therapeutic Goods Act 2012 167 Health Practitioner Regulation (National Uniform Legislation) and Other Legislation Amendment Act 2018 (Act No. 28, 2018) Assent date 30 November 2018 Commenced 1 December 2018 (s 2) Medical Services Amendment Act 2019 (Act No. 17, 2019) Assent date 30 May 2019 Commenced 31 May 2019 (s 2) Hemp Industry Act 2019 (Act No. 25, 2019) Assent date 2 September 2019 Commenced 6 May 2020 (Gaz G18, 6 May 2020, p 2) Statute Law Revision Act 2020 (Act No. 26, 2020) Assent date 19 November 2020 Commenced 20 November 2020 (s 2) Medicines, Poisons and Therapeutic Goods Amendment Act 2021 (Act No. 1, 2021) Assent date 25 February 2021 Commenced 26 February 2021 (s 2) Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2021 (Act No. 27, 2021) Assent date 15 December 2021 Commenced 16 December 2021 (s 2) Medicines, Poisons and Therapeutic Goods Legislation Amendment Act 2022 (Act No. 25, 2022) Assent date 9 December 2022 Commenced 10 December 2022 (s 2) Statute Law Revision and Repeals Act 2026 (Act No. 3, 2026) Assent date 9 February 2026 Commenced 10 February 2026 (s 2) 3 GENERAL AMENDMENTS General amendments of a formal nature (which are not referred to in the table of amendments to this reprint) are made by the Interpretation Legislation Amendment Act 2018 (Act No. 22, 2018) to: ss 1, 5, 19, 24, 32, 43, 44, 80, 89, 92, 121, 125, 127, 128, 129, 183, 207, 232, 251, 252, 283 and 293. 4 LIST OF AMENDMENTS ss 3 – 4 amd No. 4, 2017, s 21 s 5 amd No. 12, 2014, s 3; No. 4, 2017, s 21; No. 28, 2018, s 12; No. 17, 2019, s 14; No. 1, 2021, s 4; No. 27, 2021, s 4; No. 25, 2022, s 4 s 6 rep No. 4, 2017, s 20 s 7 amd No. 4, 2017, s 21 s 10 amd No. 25, 2022, s 5 s 11 rep No. 25, 2022, s 6 s 12 amd No. 4, 2017, s 21 s 13 rep No. 4, 2017, s 20 -- 183 of 187 -- ENDNOTES Medicines, Poisons and Therapeutic Goods Act 2012 168 ch 1 pt 1.2 div 2 sdiv 3 hdg amd No. 4, 2017, s 21 s 17 amd No. 4, 2017, s 21 s 19 amd No. 12, 2014, s 4 s 20 amd No. 4, 2017, s 21 s 21 amd No. 4, 2017, s 21; No. 25, 2022, s 7 s 22 amd No. 4, 2017, s 21 ch 1 pt 1.2 div 2 sdiv 4 hdg amd No. 4, 2017, s 21 s 23 amd No. 4, 2017, s 21 s 25 amd No. 25, 2022, s 8 s 26 amd No. 12, 2014, s 5 s 25 amd No. 28, 2018, s 12; No. 27, 2021, s 11 s 28 sub No. 12, 2014, s 6 amd No. 25, 2022, s 9 s 28A ins No. 12, 2014, s 6 sub No. 28, 2018, s 10 amd No. 25, 2022, s 10 s 31 amd No. 4, 2017, s 21 s 31A ins No. 25, 2019, s 46 ss 32 – 33 amd No. 4, 2017, s 21 ch 2 hdg amd No. 4, 2017, s 21 s 34 amd No. 12, 2014, s 7; No. 4, 2017, s 21 s 35 amd No. 12, 2014, s 8; No. 4, 2017, s 21 ch 2 pt 2.2 hdg amd No. 4, 2017, s 21 ss 37 – 38 sub No. 25, 2022, s 11 s 48 amd No. 25, 2022, s 12 s 57 amd No. 4, 2017, s 21; No. 27, 2021, s 11 s 59A ins No. 12, 2014, s 9 s 61 amd No. 25, 2022, s 54 s 62 sub No. 12, 2014, s 10 rep No. 25, 2022, s 13 ch 2 pt 2.3 div 1 sdiv 3 hdg amd No. 25, 2022, s 54 s 63 sub No. 12, 2014, s 11; No. 25, 2022, s 14 s 64 amd No. 28, 2018, s 12 sub No. 25, 2022, s 14 s 65 amd No. 12, 2014, s 12 rep No. 25, 2022, s 14 s 67 amd No. 12, 2014, s 13 rep No. 25, 2022, s 15 ch 2 pt 2.3 div 1 sdiv 3A hdg ins No. 25, 2022, s 16 s 70 rep No. 12, 2014, s 15 ins No. 25, 2022, s 16 ss 70A – 70D ins No. 25, 2022, s 16 -- 184 of 187 -- ENDNOTES Medicines, Poisons and Therapeutic Goods Act 2012 169 ch 2 pt 2.3 div 1 sdiv 4 hdg amd No. 12, 2014, s 14 s 71 amd No. 12, 2014, s 16 sub No. 25, 2022, s 17 s 72 amd No. 12, 2014, s 17 sub No. 25, 2022, s 17 s 73 amd No. 4, 2017, s 21 s 75 sub No. 25, 2022, s 18 s 78 amd No. 25, 2022, s 19 ss 79 – 80 amd No. 4, 2017, s 21 s 81 amd No. 27, 2021, s 11 s 83 amd No. 27, 2021, s 11 s 84 amd No. 27, 2021, s 5; No. 25, 2022, s 20 s 86 amd No. 4, 2017, s 21 s 92 amd No. 12, 2014, s 18; No. 25, 2022, s 21 s 96 amd No. 27, 2021, s 6 pt 2.6 hdg amd No. 4, 2017, s 21 s. 98 amd No. 4, 2017, s 21 s 99 amd No. 12, 2014, s 19; No. 25, 2022, s 22 s 100 amd No. 12, 2014, s 20 sub No. 25, 2022, s 23 ch 2 pt 2.7 hdg amd No. 4, 2017, s 21 ss 101 – 105 amd No. 4, 2017, s 21 s 109 rep No. 12, 2014, s 21 s 110 amd No. 12, 2014, s 22; No. 3, 2026, s 43 ch 2 pt 2.7 div 4A hdg ins No. 25, 2022, s 24 ss 112A – 112C ins No. 25, 2022, s 24 s 113 amd No. 4, 2017, s 21 ch 3 hdg amd No. 4, 2017, s 21 s 117 amd No. 25, 2022, s 25 ss 118 – 119 amd No. 4, 2017, s 21 s 120 amd No. 25, 2022, s 26 s 121 amd No. 17, 2016, s 46; No. 4, 2017, s 21 s 122 amd No. 4, 2017, s 21 s 122A ins No. 25, 2022, s 27 s 123A ins No. 25, 2022, s 28 s 127 amd No. 17, 2016, s 46 s 128 amd No. 17, 2016, s 46; No. 25, 2022, s 29 s 129 amd No. 12, 2014, s 23; No. 17, 2016, s 46; No. 25, 2022, s 30 s 130 amd No. 25, 2022, s 31 s 131 amd No. 25, 2022, s 32 s 134 amd No. 4, 2017, s 21; No. 25, 2022, s 33 s 135 amd No. 4, 2017, s 21; No. 25, 2022, s 34 s 136 amd No. 4, 2017, s 21 s 136A ins No. 25, 2022, s 35 s 140 sub No. 25, 2022, s 36 s 141 and No. 25, 2022, s 37 ss 142 – 143 amd No. 4, 2017, s 21 s 144 amd No. 12, 2014, s 24; No. 4, 2017, s 21 s 145A ins No. 25, 2022, s 38 s 182 amd No. 8, 2016, s 45 s 193 amd No. 26, 2020, s 3 -- 185 of 187 -- ENDNOTES Medicines, Poisons and Therapeutic Goods Act 2012 170 s 203 amd No. 4, 2017, s 21 s 206 amd No. 4, 2017, s 21 s 207 sub No. 27, 2021, s 7 s 215 amd No. 26, 2015, s 75 s 219 amd No. 4, 2017, s 21 s 228 amd No. 3, 2026, s 44 s 230 amd No. 25, 2022, s 39 s 236 amd No. 3, 2026, s 45 ch 7 pt 7.1AA hdg ins No. 27, 2021, s 8 ch 7 pt 7.1AA div 1 hdg ins No. 27, 2021, s 8 ss 243A – 243B ins No. 27, 2021, s 8 ch 7 pt 7.1AA div 2 hdg ins No. 27, 2021, s 8 ss 243C – 243E ins No. 27, 2021, s 8 ch 7 pt 7.1AA div 3 hdg ins No. 27, 2021, s 8 ss 243F – 243G ins No. 27, 2021, s 8 ch 7 pt 7.1AA div 4 hdg ins No. 27, 2021, s 8 ss 243H – 243L ins No. 27, 2021, s 8 ch 7 pt 7.1AA div 5 hdg ins No. 27, 2021, s 8 ss 243M – 243Q ins No. 27, 2021, s 8 s 244 amd No. 25, 2022, s 40 ch 7 pt 7.2 div 1 hdg amd No. 4, 2017, s 21 s 245 amd No. 25, 2022, s 41 s 246 amd No. 25, 2022, s 42 ss 247 – 248 rep No. 25, 2022, s 43 s 249 amd No. 12, 2014, s 25 rep No. 25, 2022, s 43 s 250 amd No. 12, 2014, s 26; No. 28, 2018, s 12 rep No. 25, 2022, s 43 s 251 amd No. 4, 2017, s 21; No. 25, 2022, s 44 s 252 amd No. 27, 2014, s 57; No. 25, 2022, s 45 s 253 amd No. 25, 2022, s 46 s 254 amd No. 12, 2014, s 27; No. 28, 2018, s 11 sub No. 25, 2022, s 47 ch 7 pt 7.2 div 1A hdg ins No. 1, 2021, s 5 rep No. 25, 2022, s 48 ss 254A – 254C ins No. 1, 2021, s 5 rep No. 25, 2022, s 48 -- 186 of 187 -- ENDNOTES Medicines, Poisons and Therapeutic Goods Act 2012 171 s 257 amd No. 4, 2017, s 21; No. 25, 2022, s 49 s 261 amd No. 12, 2014, s 28 s 266 amd No. 25, 2022, s 50 s 268 amd No. 25, 2022, s 51 s 269 amd No. 25, 2022, s 52 s 279 amd No. 4, 2017, s 21 s 281 amd No. 12, 2014, s 29; No. 4, 2017, s 21 s 283 amd No. 12, 2014, s 30; No. 4, 2017, s 21 s 294 exp No. 13, 2012, s 294(5) ch 9 pt 9.3 hdg ins No. 26, 2015, s 76 s 295 exp No. 13, 2012, s 305 ins No. 26, 2015, s 76 ch 9 pt 9.4 hdg ins No. 27, 2021, s 9 ss 296 – 298 exp No. 13, 2012, s 305 ins No. 27, 2021, s 9 ch 9 pt 9.5 hdg ins No. 25, 2022, s 53 ss 299 – 307 ins No. 25, 2022, s 53 ch 10 hdg exp No. 13, 2012, s 305 ch 10 pt 10.1 hdg exp No. 13, 2012, s 305 ss 299 – 303 exp No. 13, 2012, s 305 ch 10 pt 10.2 hdg exp No. 13, 2012, s 305 s 304 exp No. 13, 2012, s 305 ch 10 pt 10.3 hdg exp No. 13, 2012, s 305 s 305 exp No. 13, 2012, s 305 sch 1 amd No. 12, 2014, s 31 sch 2 amd No. 27, 2021, s 10 sch 4 exp No. 13, 2012, s 305 -- 187 of 187 --