MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2012 (NO 13 OF 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
Division 2--Important concepts
Subdivision 1--Substances to which this Act applies
- 6 Meaning of regulated substance
- 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
- 11 Meaning of amphetamine
- 12 Meaning of prohibited substance
- 13 Meaning of Appendix C 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 regulated 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 regulated 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 terms for other health-related occupations
PART 1.3--APPLICATION OF ACT
- 29 Act binds Crown
- 30 Inconsistency between Act and medicines and poisons standard
- 31 Relationship with Health Practitioner Regulation National Law
- 32 Relationship with Misuse of Drugs Act
- 33 Application of Part IIAA of Criminal Code
CHAPTER 2--DEALING WITH REGULATED SUBSTANCES
PART 2.1--REQUIREMENTS FOR REGISTRATION AND LICENSING OF MANUFACTURERS, WHOLESALERS AND RETAILERS
- 34 Manufacturer of regulated substances to be registered
- 35 Wholesaler of regulated 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 REGULATED SUBSTANCES
Division 1--Schedule 3 substances
Division 2--Schedule 4 substances
Division 3--Pesticides and other Schedule 7 substances
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
- 55 Schedule 4 substances and unrestricted Schedule 8 substances
Subdivision 2--Pharmacists
- 56 Possessing Schedule 4 and 8 substances
- 57 Supplying Schedule 4 and 8 substances – general
- 58 Supplying Schedule 4 and 8 substances – prescription of interstate prescribers
- 59 Supplying unrestricted Schedule 4 substance in emergency for patient previously supplied on prescription
- 60 Supplying unrestricted Schedule 4 substance for patient in residential care
- 61 Supplying Schedule 4 and 8 substances on verbal request of authorised prescriber
- 62 Qualified pharmacist may supply and administer some Schedule 4 substances
Subdivision 3--Other health practitioners and health-related occupations
- 63 Aboriginal health workers
- 64 Approved ambulance officers
- 65 Nurses and midwives
- 66 Dentists
- 67 Dental therapists
- 68 Optometrists
- 69 Podiatrists
Subdivision 4--Special provisions for health professionals to supply and administer Schedule 3 substances
- 70 Definitions
- 71 Sales and other supplies of Schedule 3 substances
- 72 Administering Schedule 3 substances
Subdivision 5--Additional qualifications for health practitioners under Health Practitioner Regulation National Law
- 73 Endorsement on health practitioner's registration for additional qualifications
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 – therapeutic use or treating addiction
- 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 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 REGULATED 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 Supply or administration of Schedule 8 substance to be witnessed
PART 2.7--OTHER REQUIREMENTS FOR REGULATED SUBSTANCES
Division 1--Packaging and labelling
- 101 Packaging supplied regulated substances
- 102 Labelling supplied regulated substances
- 103 Permanently marked containers – use for other regulated substances
- 104 Regulated 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 5--Miscellaneous matters
- 113 Advertising some regulated 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 REGULATED 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
- 123 Retailer licence
- 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
- 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
- 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
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 Confidentiality of 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 7.1--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 regulated substances
- 245 Exemption from holding Schedule 8 authorisation
- 246 Restricted Schedule 4 and 8 substances
- 247 Declared medical condition
- 248 Excluded person
- 249 Conditions for dental therapist supplying unrestricted Schedule 4 substance
- 250 Approved nurses, midwives, Aboriginal health workers and ambulance officers
- 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 Scheduled substance treatment protocol
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
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
- 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
- 294 Transitional regulations
CHAPTER 10--CONSEQUENTIAL AMENDMENTSPART
PART 10.2--OTHER LAWS
PART 10.3--EXPIRY OF CHAPTER