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MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2012

Table of Provisions

CHAPTER 1--INTRODUCTION

PART 1.1--PRELIMINARY MATTERS

  • 1 Short title  
  • 2 Commencement  
  • 3 Objects  
  • 4 Overview  

PART 1.2--INTERPRETATION

Division 1--Defined terms

  • 5 Definitions  

Division 2--Important concepts

Subdivision 1--Substances to which this Act applies
  • 7 Meaning of Scheduled substance and related terms  
  • 8 Meaning of unrestricted Schedule 4 substance and restricted Schedule 4 substance  
  • 9 Meaning of pesticide  
  • 10 Meaning of unrestricted Schedule 8 substance and restricted Schedule 8 substance  
  • 12 Meaning of prohibited substance  
  • Subdivision 2--Medicines and poisons standard
  • 14 Meaning of medicines and poisons standard  
  • 15 Interpretation provisions in medicines and poisons standard – application to Act  
  • 16 When medicines and poisons standard applies to substances  
  • Subdivision 3--Dealing with Scheduled substances
  • 17 Meaning of deal with  
  • 18 Meaning of manufacture  
  • 19 Meaning of prescription  
  • 20 Meaning of possess  
  • 21 Meaning of supply and sell  
  • 22 Meaning of use and administer  
  • Subdivision 4--Health practitioners and others authorised to deal with Scheduled substances
  • 23 Meaning of health practitioner and related terms  
  • 24 Meaning of doctor and NT doctor  
  • 25 Meaning of nurse , midwife and related terms  
  • 26 Meaning of dentist and dental therapist  
  • 27 Meaning of optometrist , pharmacist and podiatrist  
  • 28 Meaning of Aboriginal and Torres Strait Islander health practitioner  
  • 28A Meaning of paramedic  

PART 1.3--APPLICATION OF ACT

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  
  • 35 Wholesaler of certain Scheduled substances to be registered  
  • 36 Retailer of Schedule 2 and 7 substances to be licensed  

PART 2.2--REQUIREMENTS FOR AUTHORISED POSSESSION, SUPPLY AND USE OF SCHEDULED SUBSTANCES

Division 1--Schedule 3 substances

  • 37 Supply of Schedule 3 substance  
  • 38 Administration of Schedule 3 substance  

Division 2--Schedule 4 substances

Division 3--Pesticides and other Schedule 7 substances

  • 42 Supply by authorised persons only  
  • 43 Supply to authorised persons only  
  • 44 Use  

Division 4--Schedule 8 substances

Subdivision 1--Unrestricted Schedule 8 substances

Division 5--Prohibited 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 1--Authorised health practitioners

Division 2--Other authorisations

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  
  • 82 Restricted Schedule 4 substance  
  • Subdivision 2--Schedule 8 substances
  • 83 Unrestricted Schedule 8 substance – general  
  • 84 Unrestricted Schedule 8 substance – prohibited circumstances  
  • 85 Restricted Schedule 8 substance  
  • Subdivision 3--Additional qualifications for health practitioners under Health Practitioner Regulation National Law
  • 86 Endorsement on health practitioner's registration for additional qualifications  

Division 2--Issue of prescriptions

Division 3--Orders for administering and supplying Schedule 4 and 8 substances

  • 92 Authorised prescriber may authorise administration and supply by order  

PART 2.5--SPECIAL PROVISIONS ABOUT SUPPLIES OF SCHEDULE 4 AND 8 SUBSTANCES

  • 93 Supply of Schedule 4 and 8 substances on prescription  
  • 94 Repeat supply of Schedule 8 substance  
  • 95 Health practitioner to ensure self-administration of some supplied Schedule 8 substances  
  • 96 Pharmacist to give CHO prescription for supply of Schedule 8 substance  
  • 97 Obligations of authorised prescriber and pharmacist for supply made without prescription in emergency  

PART 2.6--SPECIAL PROVISIONS ABOUT DEALING WITH SCHEDULED SUBSTANCES IN HOSPITALS, RESIDENTIAL FACILITIES AND DECLARED PLACES

  • 98 Storage at hospital  
  • 99 Administering Schedule 3, 4 or 8 substance at hospital, residential facility or declared place  
  • 100 Administration or supply of Schedule 8 substance to be witnessed  

PART 2.7--OTHER REQUIREMENTS FOR SCHEDULED SUBSTANCES

Division 1--Packaging and labelling

  • 101 Packaging supplied Scheduled substances  
  • 102 Labelling supplied Scheduled substances  
  • 103 Permanently marked containers – use for other Scheduled substances  
  • 104 Scheduled substance container not to be used for human-use substance  

Division 2--Vending machine supplies

  • 105 Definitions  
  • 106 Vending machine supplies of unscheduled substances  

Division 3--Methylated spirit

  • 107 Drinking methylated spirit  
  • 108 Supplying methylated spirit for drinking  

Division 4--Paints

Division 4A--Advertising use of pesticides

  • 112A Definition  
  • 112B Representation by unauthorised person  
  • 112C Advertisement to include authorisation number  

Division 5--Miscellaneous matters

  • 113 Advertising some Scheduled substances  
  • 114 No self-administration of Schedule 8 or restricted Schedule 4 substances  

PART 2.8--CHO PROHIBITIONS

  • 115 Temporary prohibition on dealing with substance  
  • 116 Prohibition on health practitioner or veterinarian dealing with Schedule 8 substance  

CHAPTER 3--AUTHORITIES TO DEAL WITH SCHEDULED SUBSTANCES

PART 3.1--PRELIMINARY MATTERS

Division 1--Interpretation

  • 117 Types of authorities  
  • 118 Suitability of authority holder – individuals  
  • 119 Suitability of authority holder – bodies corporate  
  • 120 Suitability of nominated person – certificate of registration  

Division 2--Authorised activities under authorities

  • 121 Manufacturer certificate of registration  
  • 122 Wholesaler certificate of registration  
  • 122A Schedule 4 supplier certificate of registration  
  • 123 Retailer licence  
  • 123A Schedule 3 authorisation  
  • 124 Schedule 4 authorisation  
  • 125 Schedule 7 authorisation  
  • 126 Pest management technician licence  
  • 127 Schedule 8 authorisation  
  • 128 Prohibited substance authorisation  
  • 129 Research authorisation  
  • 130 Medical kit authorisation  

PART 3.2--APPLICATION PROCESS FOR AUTHORITIES

Division 1--Making and consideration of application

  • 131 Making application  
  • 132 CHO may require further information  
  • 133 CHO to give application for Schedule 8 authorisation to Committee  
  • 134 Considering and deciding application  

Division 2--Restrictions on issue of authorities

  • 135 Certificate of registration  
  • 136 Retailer licence  
  • 136A Schedule 3 authorisation  
  • 137 Schedule 4 authorisation  
  • 138 Pest management technician licence  
  • 139 Schedule 8 authorisation  
  • 140 Prohibited substance authorisation  
  • 141 Research authorisation  
  • 142 Medical kit authorisation  

Division 3--Conditions of authorities

  • 143 Conditions – general  
  • 144 Conditions – certificate of registration  
  • 145 Conditions – retailer licence  
  • 145A Conditions – Schedule 3 authorisation  
  • 146 Conditions – Schedule 8 authorisation  
  • 147 Contravention of condition  

Division 4--Miscellaneous matters

  • 148 Duration of authority  
  • 149 Form of authority  
  • 150 Notice of refusal to issue authority or impose conditions  
  • 151 Failure to decide application  

PART 3.3--RENEWAL OF LICENCES AND CERTIFICATES OF REGISTRATION

  • 152 Application for renewal  
  • 153 Authority continues until application decided  

PART 3.4--TRANSFER OF AUTHORITIES

  • 154 Transfer of certificate of registration  
  • 155 Other authorities not transferable  

PART 3.5--VARIATION OF CONDITIONS OF AUTHORITIES

Division 1--Interpretation

  • 156 Definitions  

Division 2--Variation of conditions of authority on CHO's initiative

  • 157 CHO may vary conditions to achieve object of Act  

Division 3--Variation of conditions of authority on application by holder

  • 158 Application  
  • 159 CHO may require further information  
  • 160 Considering and deciding application  
  • 161 Notice of decision on application  
  • 162 Failure to decide application  

Division 4--Miscellaneous matters

  • 163 Application of Division  
  • 164 When variation of conditions takes effect  
  • 165 Recording variation of conditions  

PART 3.6--SUSPENSION AND CANCELLATION OF AUTHORITIES

  • 166 Grounds for suspending or cancelling authority  
  • 167 Show cause notice  
  • 168 Ending show cause process without further action  
  • 169 Suspension or cancellation  
  • 170 Return of cancelled authority to CHO  
  • 171 Immediate suspension of authority pending formal cancellation procedure  

PART 3.7--MISCELLANEOUS MATTERS

  • 172 Medical examination for some authorities  
  • 173 Authority holder to give notice of change of particulars  
  • 174 Replacement of authority  
  • 175 Surrender of authority  
  • 176 Display of certificate of registration  
  • 177 Authority not personal property  

CHAPTER 4--ENFORCEMENT

PART 4.1--INTERPRETATION

  • 178 Definitions  
  • 179 When thing is connected with offence  

PART 4.2--POWERS OF AUTHORISED OFFICERS TO ENTER PLACES

  • 180 Entry of place – general  
  • 181 Consent to entry  
  • 182 Entry of place – search warrant  
  • 183 Entry to Aboriginal land  
  • 184 Additional powers for entry of aircraft, vehicle or vessel  

PART 4.3--POWERS OF AUTHORISED OFFICERS ON ENTRY OF PLACES

  • 185 Powers on entry of place  
  • 186 Restriction on power of seizure  
  • 187 Authorised officer may use help and force in exercising powers  

PART 4.4--SEIZED AND FORFEITED THINGS

Division 1--Notice, retention and return of seized thing

  • 188 Application of Division  
  • 189 Notice of seizure of thing  
  • 190 Retention of thing seized  
  • 191 Return of seized thing  

Division 2--Order disallowing seizure of seized thing

  • 192 Application for order disallowing seizure  
  • 193 CHO is respondent to application  
  • 194 Order disallowing seizure  
  • 195 Ancillary orders  
  • 196 Adjournment pending hearing of other proceeding  

Division 3--Forfeiture of seized thing

  • 197 When seized thing is forfeited  
  • 198 Destruction or disposal of forfeited thing  
  • 199 Return of forfeited thing  
  • 200 Compensation to be paid in certain circumstances  

PART 4.5--GENERAL POWERS OF CHO AND AUTHORISED OFFICERS

  • 201 Compliance notice  
  • 202 Contravention of compliance notice  
  • 203 Power to prohibit supply of incorrectly packed or labelled substance  
  • 204 Power to require name and address  
  • 205 Power to require information from persons  
  • 206 Requirement to give documents or information  

PART 4.6--OTHER OFFENCES

  • 207 Offence to disclose certain information  
  • 208 Misleading information  
  • 209 Obstruction of authorised officer or assistant  
  • 210 Falsely representing to be authorised officer  
  • 211 Bribery of authorised officer  

PART 4.7--LEGAL PROCEEDINGS AND EVIDENTIARY MATTERS

Division 1--Criminal liability for offences

  • 212 Definitions  
  • 213 Liability of representative  
  • 214 Conduct of representative  
  • 215 Criminal liability of executive officer of body corporate  

Division 2--Miscellaneous matters

  • 216 Self-incrimination  
  • 217 Judicial notice  
  • 218 Time for starting offence proceeding  
  • 219 Evidentiary certificate  

CHAPTER 5--RECONSIDERATION AND REVIEW OF DECISIONS

  • 220 Meaning of original decision and affected person  
  • 221 Request for reconsideration of original decision  
  • 222 Operation and implementation of original decision  
  • 223 Reconsideration of decision  
  • 224 Application for review of reconsidered decision  
  • 225 Operation and implementation of reconsidered decision  
  • 226 Review procedure  
  • 227 Decision on review  

CHAPTER 6--THERAPEUTIC GOODS ACT APPLIES AS A LAW OF THE TERRITORY

PART 6.1--INTERPRETATION

  • 228 Definitions  
  • 229 Words have meanings in Therapeutic Goods Act  

PART 6.2--APPLIED PROVISIONS

  • 230 Application of Therapeutic Goods Act as law of Territory  
  • 231 Modification of Therapeutic Goods Act  
  • 232 Interpretation of applied provisions  

PART 6.3--FUNCTIONS AND POWERS UNDER APPLIED PROVISIONS

  • 233 Functions and powers of Commonwealth Minister and officials  
  • 234 Delegations by Commonwealth Minister and Secretary  
  • 235 Appointments under Therapeutic Goods Act  

PART 6.4--ADMINISTRATIVE LAW

  • 236 Application of Commonwealth administrative laws to applied provisions  
  • 237 Functions and powers conferred on Commonwealth officers and authorities  

PART 6.5--OFFENCES UNDER APPLIED PROVISIONS

  • 238 Object of Part  
  • 239 Application of Commonwealth criminal laws to offences against applied provisions  
  • 240 Functions and powers conferred on Commonwealth officials relating to offences  
  • 241 No double jeopardy for offences against applied provisions  

PART 6.6--MISCELLANEOUS MATTERS

  • 242 Reference in Commonwealth law to provision of another law  
  • 243 Fees and other money  

CHAPTER 7--ADMINISTRATIVE MATTERS

PART 7.1AA--MONITORED MEDICINES DATABASE

Division 1--Interpretation

Division 2--Establishment and maintenance of monitored medicines database

Division 3--Access to monitored medicines database

Division 4--Offences

Division 5--Administrative matters

PART 7.1--CODES OF PRACTICE

  • 244 CHO may make code of practice  

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  
  • 246 Restricted Schedule 4 and 8 substances  
  • 251 Emergency authorisation for possessing, supplying and administering Schedule 3, 4 and 8 substances  
  • 252 Declared places  
  • 253 Approval for pharmacist to supply Schedule 8 substance or restricted Schedule 4 substances on interstate prescription  
  • 254 Approval of SSTP  

Division 2--Register of authorities and information availability

  • 255 Register of authorities  
  • 256 Public access to some registers  

Division 3--Other administrative powers

  • 257 Information relating to supply and use of substances  
  • 258 Approved forms  
  • 259 Delegation by CHO  

PART 7.3--SCHEDULED SUBSTANCES CLINICAL ADVISORY COMMITTEE

Division 1--Establishment, functions and powers

  • 260 Establishment  
  • 261 Functions  
  • 262 Powers  
  • 263 Delegation  

Division 2--Provisions about membership

  • 264 Membership  
  • 265 Qualifications and nominations for appointment  
  • 266 Duration of appointment  
  • 267 Conditions of appointment  
  • 268 Chairperson and deputy chairperson  
  • 269 When member ceases to hold office  

Division 3--Conduct of business

  • 270 Meetings  
  • 271 Presiding member at meetings  
  • 272 Procedure at meetings  
  • 273 Disclosure of interest  

PART 7.4--AUTHORISED OFFICERS

  • 274 Who is authorised officer  
  • 275 Identity cards  
  • 276 Production of identity card  
  • 277 Return of identity card  

CHAPTER 8--MISCELLANEOUS MATTERS

  • 278 Acquisition on just terms  
  • 279 Protection of health practitioners and veterinarians from liability  
  • 280 Protection of persons administering Act from liability  
  • 281 Regulations  

CHAPTER 9--REPEALS AND TRANSITIONAL MATTERSPART

  • 282 Repeals  

PART 9.2--TRANSITIONAL MATTERS FOR MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2012

  • 283 Definitions  
  • 284 Prescriptions and directions for dealing with Scheduled substances  
  • 285 Old authority  
  • 286 Pending application relating to authority  
  • 287 Pending action to vary, suspend or revoke authorisation  
  • 288 Suspended authorisation  
  • 289 Provisions relating to employment involving pesticides  
  • 290 Directions under section 30 of repealed Act  
  • 291 Prohibitions under sections 31 and 31N of repealed Act  
  • 292 Registers of manufacturer and wholesaler premises  
  • 293 Interpretation Act not affected  

PART 9.3--TRANSITIONAL MATTERS FOR STATUTE LAW AMENDMENT (DIRECTORS' LIABILITY) ACT 2015

  • 295 Offences – before and after commencement  

PART 9.4--TRANSITIONAL MATTERS FOR MEDICINES, POISONS AND THERAPEUTIC GOODS LEGISLATION AMENDMENT ACT 2021

  • 296 Definitions  
  • 297 Information obtained before commencement  
  • 298 Offences – before and after commencement  

PART 9.5--TRANSITIONAL MATTERS FOR MEDICINES, POISONS AND THERAPEUTIC GOODS LEGISLATION AMENDMENT ACT 2022

  • 299 Definitions  
  • 300 Scheduled substance treatment protocols approved before commencement  
  • 301 Transitional authority for health practitioners approved to administer Schedule 4 or 8 substance before commencement  
  • 302 Transitional authority for health practitioners approved to supply Schedule 4 or 8 substance before commencement  
  • 303 COVID-19 vaccine administration protocols approved before commencement  
  • 304 Transitional authority for persons authorised to deal with COVID-19 vaccine before commencement  
  • 305 Supply of Schedule 3 substances – authorities issued before commencement  
  • 306 Declared places  
  • 307 Offence provisions – before and after commencement  

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