MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2008

Australian Capital Territory Current Acts

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MEDICINES, POISONS AND THERAPEUTIC GOODS ACT 2008

TABLE OF PROVISIONS

Long Title

CHAPTER 1--PRELIMINARY

1. Name of Act
3. Dictionary
4. Notes
5. Offences against Act—application of Criminal Code etc

CHAPTER 2--OPERATION OF ACT

6. Objects
7. Appropriate prescription and supply of medicines
8. Obligations under other territory laws
9. Inconsistency between Act and medicines and poisons standard
9A. Application of Act to certain cannabis use not prohibited under Drugs of Dependence Act

CHAPTER 3--IMPORTANT CONCEPTS

PART 3.1--SUBSTANCES TO WHICH ACT APPLIES

10. Meaning of regulated substance—Act
11. Medicine-related definitions
12. Poison-related definitions
13. Meaning of prohibited substance and schedule 10

PART 3.2--THERAPEUTIC GOODS TO WHICH ACT APPLIES

14. Meaning of regulated therapeutic good—Act

PART 3.3--MEDICINES AND POISONS STANDARD

15. Meaning of medicines and poisons standard—Act
16. Interpretation provisions in medicines and poisons standard—application to
17. When medicines and poisons standard applies to substances
18. Inspection of medicines and poisons standard

PART 3.4--OTHER IMPORTANT CONCEPTS

19. Meaning of deals with a regulated substance—Act
20. When authorised to deal with regulated substances
21. Meaning of deals with a regulated therapeutic good—Act
22. When authorised to deal with regulated therapeutic goods
23. Meaning of supply authority—Act
24. Meaning of possess, sell and supply—Act

CHAPTER 4--OFFENCES RELATING TO REGULATED SUBSTANCES

PART 4.1--DEALINGS WITH REGULATED SUBSTANCES--OFFENCES

Division 4.1.1--Preliminary

25. Meaning of declared substance—pt 4.1

Division 4.1.2--Declared substances—supply

26. Supplying declared substances
27. Supplying declared substances on invalid supply authorities—strict liability
28. Supplying declared substances on invalid supply
29. Supplying declared substances on invalid supply authorities—other offences
30. Cancellation etc of invalid supply authorities for declared substances
31. Supply of certain declared substances—information for chief health
32. Information about invalid supply authorities for chief health officer

Division 4.1.3--Regulated substances—other dealings

33. Manufacturing regulated substances
34. Discarding declared etc substances
35. Obtaining certain declared substances
36. Possessing certain declared substances
37. Administering certain declared substances
38. Issuing purchase orders for declared substances
39. Reporting loss and theft of certain regulated substances
40. Prescribing medicines
41. Issuing requisitions for medicines
42. Issuing standing orders for medicines
43. Medicines for animals not to be prescribed etc for human use

Division 4.1.4--Dealings—other offences

44. Contravening authorisation conditions for regulated substances
45. Pretending to be authorised to deal with regulated substance

PART 4.2--RECORDS FOR REGULATED SUBSTANCES--OFFENCES

Division 4.2.1--Record-keeping generally

46. Accessibility of records
47. Keeping cancelled invalid supply authorities

Division 4.2.2--Registers for regulated substances

48. Meaning of must keep register—div 4.2.2
49. Registers—not keeping
50. Registers—where to be kept
51. Registers—duty to ensure entries made
52. Registers—signing entries
53. Registers—witnessing administration of medicines
54. Registers—witnessing discarding
55. Registers—changes etc to entries
56. Registers—period to be kept
57. Registers—damage or loss
58. Transferring responsibility for community pharmacies—stocktake etc of controlled

PART 4.3--REGULATED SUBSTANCES--OTHER OFFENCES

Division 4.3.1--Packaging and labelling—offences

59. Packaging of supplied regulated substances
60. Labelling of supplied regulated substances

Division 4.3.2--Storage—offence

61. Storing declared substances

Division 4.3.3--Containers—offences

62. Permanently named containers—use for other regulated substances
63. Certain containers not to be used for human-use substances

Division 4.3.4--Representations and advertisements—offences

64. False statements to obtain certain regulated substances etc
65. Falsely representing substance is regulated
66. Advertising controlled medicines and prohibited substances

Division 4.3.5--Vending machines—offences

67. Meaning of vending machine—div 4.3.5
68. Vending machines—use for supply of regulated substances
69. Vending machines—use for supply of unscheduled medicines

Division 4.3.6--Paints—offences

70. Manufacture, supply and use of paints containing white lead
71. Manufacture, supply and use of paints for certain purposes
72. Manufacture, supply and use of paints for toys
73. Manufacture, supply and use of paints containing pesticides

CHAPTER 5--OFFENCES RELATING TO REGULATED THERAPEUTIC GOODS

74. Supplying regulated therapeutic goods
75. Contravening authorisation conditions for regulated therapeutic goods
76. Pretending to be authorised to deal with regulated therapeutic goods
77. Falsely representing thing is regulated

CHAPTER 6--LICENCES FOR REGULATED SUBSTANCES AND REGULATED THERAPEUTIC GOODS

PART 6.1--LICENCES GENERALLY

78. Meaning of licence etc—ch 6
79. Meaning of close associate—ch 6
80. Meaning of influential person for corporation—ch 6
81. Suitability of individuals for licences
82. Suitability of corporations for licences
83. Power to ask for information etc from applicants and others

PART 6.2--LICENCES--ISSUE AND AMENDMENT

84. Applications for licences
85. Decision on applications for licences
86. Term of licences
87. Licences not transferable
88. Form of licences
89. Statutory licence conditions
90. Other licence conditions
91. Amending licence on chief health officer's initiative
92. Amending licence on application by licence-holder
93. Licensee to keep chief health officer informed
94. Returning licences for amendment
95. Replacing licences

PART 6.3--LICENCES--OTHER PROVISIONS

96. Contravening licence conditions
97. Surrendering licences

CHAPTER 6A--MONITORED MEDICINES DATABASE

97A. Meaning of monitored medicine
97B. Definitions—ch 6A
97C. Monitored medicines database—purposes
97D. Monitored medicines database—scope
97E. Monitored medicines database—chief health officer functions
97F. Monitored medicines database—access and use by relevant health
97G. Monitored medicines database—access authority
97H. Monitored medicines database—offences

CHAPTER 7--ENFORCEMENT

PART 7.1--INSPECTION AND SEIZURE POWERS

Division 7.1.1--Preliminary

98. Definitions—pt 7.1
99. Meaning of medicines and poisons inspector—Act

Division 7.1.2--Medicines and poisons inspectors

100. Appointment of medicines and poisons inspectors
101. Identity cards

Division 7.1.3--Powers of medicines and poisons inspectors

102. Power to enter premises
103. Production of identity card
104. Consent to entry
105. General powers on entry to premises
106. Power to seize things
107. Power to destroy unsafe things
108. Power to require name and address

Division 7.1.4--Search warrants

109. Warrants generally
110. Warrants—application made other than in person
111. Search warrants—announcement before entry
112. Details of search warrant to be given to occupier etc
113. Occupier entitled to be present during search etc
114. Moving things to another place for examination or processing
115. Use of electronic equipment at premises
116. Person with knowledge of computer to assist access etc
117. Securing electronic equipment
118. Copies of seized things to be provided

Division 7.1.5--Return and forfeiture of things seized

119. Receipt for things seized
120. Access to things seized
121. Return of things seized
122. Application for order disallowing seizure
123. Order for return of seized thing
124. Adjournment pending hearing of other proceedings
125. Forfeiture of seized things
126. Return of forfeited things
127. Cost of disposal of forfeited things

Division 7.1.6--Medicines and poisons inspectors—other provisions

128. Disposal etc of things obtained otherwise than under pt 7.1
129. Damage etc to be minimised
130. Compensation for exercise of enforcement powers

PART 7.2--TAKING AND ANALYSIS OF SAMPLES OF SUBSTANCES

131. Inspector may buy samples without complying with pt 7.2
132. Person in charge etc to be told sample to be analysed
133. Payment for samples
134. Samples from packaged substances
135. Procedures for dividing samples
136. Exception to usual procedures for dividing samples
137. Certificates of analysis by authorised analysts

CHAPTER 8--RESTRICTIONS ON DEALING WITH REGULATED SUBSTANCES AND REGULATED THERAPEUTIC GOODS

PART 8.1--AUTHORISATIONS--DISCIPLINARY ACTION

138. Application—pt 8.1
139. Definitions—pt 8.1
140. Grounds for disciplinary action against authorisation holders
141. Disciplinary action against authorisation holders
142. Taking disciplinary action against authorisation holders
143. Immediate suspension of authorisations
144. Effect of suspension of authorisations
145. Return of certain licences and approvals
146. Action by chief health officer in relation to certain licences and

PART 8.2--CONTROLLED MEDICINES AND PROHIBITED SUBSTANCES--DISQUALIFICATION BY COURTS

147. Definitions—pt 8.2
148. Drug offences—disqualification from dealing
149. Notice of disqualification from dealing
150. Effect of disqualification from dealing

PART 8.3--SURRENDER OF PRESCRIBED AUTHORISATIONS

151. Application—pt 8.3
152. Surrender of authorisation under regulation
153. Effect of surrender of authorisation under regulation

CHAPTER 9--NOTIFICATION AND REVIEW OF DECISIONS

154. Meaning of reviewable decision—ch 9
155. Reviewable decision notices
155A. Applications for review

CHAPTER 10--INCORPORATION OF COMMONWEALTH THERAPEUTIC GOODS LAWS

PART 10.1--PRELIMINARY

156. Definitions—ch 10

PART 10.2--APPLICATION IN ACT OF COMMONWEALTH THERAPEUTIC GOODS LAWS

Division 10.2.1--The applied provisions

157. Application of Commonwealth therapeutic goods laws to ACT
158. Interpretation of Commonwealth therapeutic goods laws

Division 10.2.2--Functions under applied provisions

159. Functions of Commonwealth Minister
160. Functions of Commonwealth Secretary
161. Functions of other people
162. Delegations by Commonwealth Minister or Secretary
163. Appointments under Commonwealth therapeutic goods laws

Division 10.2.3--Applied provisions—administrative law matters

164. Application of Commonwealth administrative laws to applied provisions
165. Functions given to Commonwealth officers and authorities

Division 10.2.4--Applied provisions—offences

166. Object—div 10.2.4
167. Application of Commonwealth criminal laws to offences against applied
168. Functions of Commonwealth officers and authorities relating to
169. No double jeopardy for offences against applied provisions

Division 10.2.5--Applied provisions—other provisions

170. Commonwealth may keep fees paid to Commonwealth Secretary

CHAPTER 11--PROCEDURAL AND EVIDENTIARY PROVISIONS

PART 11.1--GENERAL PROVISIONS ABOUT OFFENCES AGAINST ACT

171. Acts and omissions of representatives of individuals
172. Criminal liability of executive officers
173. No defence to claim deterioration of sample
174. Remedial orders by court for offences
175. Court may order costs and expenses
176. Court may order forfeiture
177. Notices of noncompliance by territory entities

PART 11.2--EVIDENTIARY PROVISIONS

178. Evidence—authorisations under Commonwealth and State laws
179. Presumptions
180. Certificate evidence etc
181. Admissibility of analysis of samples taken by inspectors
182. Power of court to order further analysis

CHAPTER 12--REGULATIONS ABOUT REGULATED SUBSTANCES AND REGULATED THERAPEUTIC GOODS

183. Meaning of regulated thing—ch 12
184. Regulation-making power
185. Regulations—regulated things
186. Regulations—authorisations
187. Regulations—records kept electronically
188. Regulations—medicines advisory committee
189. Regulations—application etc of instruments
190. Regulations—exemption of people, dealings etc

CHAPTER 13--MISCELLANEOUS

191. Directions about dealings with regulated substances and therapeutic
192. Guidelines about dealings with regulated substances and therapeutic
193. Approval of non-standard packaging and labelling
194. Establishment of medicines advisory committee
195. Secrecy
196. Protection of officials from liability
197. Determination of fees
SCHEDULE 1
DICTIONARY
ENDNOTES

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