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MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2012
TABLE OF PROVISIONS
Long Title
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
29. Act binds Crown
30. Inconsistency between Act and medicines and poisons standard
31. Relationship with Health Practitioner Regulation National Law
31A. Relationship with Hemp Industry Act 2019
32. Relationship with Misuse of Drugs Act 1990
33. Application of Criminal Code
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
39. Possession
40. Supply
41. Use
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
45. Possession
46. Supply generally
47. Use generally
48. Supplying and administering in prohibited circumstances
Subdivision 2--Restricted Schedule 8 substances
49. Possession
50. Supply
51. Use
Division 5--Prohibited substances
52. Possession
53. Supply
54. Use
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
59A. Supplying unrestricted Schedule 4 substance – continued dispensing
60. Supplying unrestricted Schedule 4 substance for patient in residential care
61. Supplying Schedule 4 and 8 substances on oral request of authorised prescriber
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
64. Administering Schedule 4 or 8 substances supplied on supply order – nurses employed at residential facilities
66. Dentists
68. Optometrists
69. Podiatrists
Subdivision 3A--Administering, supplying and possessing Scheduled substances under SSTP
70. Definitions
70A. Prescribed health practitioners and healthcare workers
70B. Form and content of SSTP
70C. Administering, supplying and possessing Schedule 4 or 8 substance under SSTP – prescribed health practitioners
70D. Administering, supplying and possessing Schedule 3, 4 or 8 substance under SSTP – prescribed healthcare workers
Subdivision 4--Special provisions for health practitioners to supply and administer Schedule 3 substances
71. Supplying 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
74. Veterinarians
75. Supplying and administering Schedule 3 substance supplied by health practitioner
76. Possessing and administering lawfully supplied Schedule 4 and 8 substances for administering to patients
77. Possessing and administering lawfully supplied Schedule 4 and 8 substances for administering to animals
78. Possessing, supplying and administering Schedule 3, 4 and 8 substances under emergency authorisation
79. Possessing Scheduled substances for delivery
80. Possessing Scheduled substances for destruction
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
87. Requirements for prescription
88. Duration of prescription
89. Issuing prescription to patient
90. No self-prescription of Schedule 8 or restricted Schedule 4 substances
91. Quantity of Schedule 8 substance authorised by prescription
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
110. Manufacture, supply and use of first, second and third schedule paints
111. Manufacture, supply and use of paints for toys
112. Manufacture, supply and use of paints containing pesticides
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
243A. Definitions
243B. Meaning of recordable prescription and recordable supply
Division 2--Establishment and maintenance of monitored medicines database
243C. Monitored medicines database to be kept
243D. Powers and functions of CHO in relation to database
243E. Persons required to give information to CHO
Division 3--Access to monitored medicines database
243F. Access for relevant prescribers and pharmacists
243G. Access for other persons
Division 4--Offences
243H. Person must not contravene requirement to give information
243J. Relevant prescriber must check database before prescribing monitored medicine
243K. Pharmacist must check database before supplying monitored medicine
243L. Unauthorised access, use or disclosure of information
Division 5--Administrative matters
243M. Protection from liability for duties and functions in relation to database
243N. Data source entity
243P. Sharing agreement
243Q. Guidelines
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
SCHEDULE 1
SCHEDULE 2
SCHEDULE 3
ENDNOTES
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