Medicines, Poisons and Therapeutic Goods Act 2008

26 November 2025. It also includes any commencement, amendment, repeal or expiry affecting this republished law to 26 November 2025. The legislation history and amendment history of the republished law are set out in endnotes 3 and 4. Kinds of republications The Parliamentary Counsel’s Office prepares 2 kinds of republications of ACT laws (see the ACT legislation register at www.legislation.act.gov.au): • authorised republications to which the Legislation Act 2001 applies • unauthorised republications. The status of this republication appears on the bottom of each page. Editorial changes The Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial amendments and other changes of a formal nature when preparing a law for republication. Editorial changes do not change the effect of the law, but have effect as if they had been made by an Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The changes are made if the Parliamentary Counsel considers they are desirable to bring the law into line, or more closely into line, with current legislative drafting practice. This republication includes amendments made under part 11.3 (see endnote 1). Uncommenced provisions and amendments If a provision of the republished law has not commenced, the symbol U appears immediately before the provision heading. Any uncommenced amendments that affect this republished law are accessible on the ACT legislation register (www.legislation.act.gov.au). For more information, see the home page for this law on the register. Modifications If a provision of the republished law is affected by a current modification, the symbol M appears immediately before the provision heading. The text of the modifying provision appears in the endnotes. For the legal status of modifications, see the Legislation Act 2001, section 95. Penalties At the republication date, the value of a penalty unit for an offence against this law is $160 for an individual and $810 for a corporation (see Legislation Act 2001, s 133).

contents 1 Page 1 Name of Act 2 3 Dictionary 2 4 Notes 2 5 Offences against Act—application of Criminal Code etc 2 6 Objects 3 7 Appropriate prescription and supply of medicines 4 8 Obligations under other territory laws 4 9 Inconsistency between Act and medicines and poisons standard 4

Page contents 2 Medicines, Poisons and Therapeutic Goods Act 2008 9A Application of Act to certain cannabis use not prohibited under Drugs of Dependence Act 1989 5 10 Meaning of regulated substance—Act 6 11 Medicine-related definitions 6 12 Poison-related definitions 7 13 Meaning of prohibited substance and schedule 10 substance—Act 8 Part 3.2 Therapeutic goods to which Act applies 14 Meaning of regulated therapeutic good—Act 9 15 Meaning of medicines and poisons standard—Act 10 16 Interpretation provisions in medicines and poisons standard— application to Act 10 17 When medicines and poisons standard applies to substances 11 18 Inspection of medicines and poisons standard 12 19 Meaning of deals with a regulated substance—Act 13 20 When authorised to deal with regulated substances 14 21 Meaning of deals with a regulated therapeutic good—Act 17 22 When authorised to deal with regulated therapeutic goods 17 23 Meaning of supply authority—Act 18 24 Meaning of possess, sell and supply—Act 18 Part 4.1 Dealings with regulated substances— offences 25 Meaning of declared substance—pt 4.1 20

Page contents 3 26 Supplying declared substances 20 27 Supplying declared substances on invalid supply authorities—strict liability offences 21 28 Supplying declared substances on invalid supply authorities— recklessness 22 29 Supplying declared substances on invalid supply authorities—other offences 23 30 Cancellation etc of invalid supply authorities for declared substances 24 31 Supply of certain declared substances—information for chief health officer 25 32 Information about invalid supply authorities for chief health officer 26 33 Manufacturing regulated substances 29 34 Discarding declared etc substances 29 35 Obtaining certain declared substances 31 36 Possessing certain declared substances 31 37 Administering certain declared substances 32 38 Issuing purchase orders for declared substances 33 39 Reporting loss and theft of certain regulated substances 34 40 Prescribing medicines 35 41 Issuing requisitions for medicines 36 42 Issuing standing orders for medicines 36 43 Medicines for animals not to be prescribed etc for human use 37 44 Contravening authorisation conditions for regulated substances 38 45 Pretending to be authorised to deal with regulated substance 39 46 Accessibility of records 40 47 Keeping cancelled invalid supply authorities 41 48 Meaning of must keep register—div 4.2.2 41 49 Registers—not keeping 42

Page contents 4 Medicines, Poisons and Therapeutic Goods Act 2008 50 Registers—where to be kept 42 51 Registers—duty to ensure entries made 43 52 Registers—signing entries 43 53 Registers—witnessing administration of medicines 43 54 Registers—witnessing discarding 44 55 Registers—changes etc to entries 45 56 Registers—period to be kept 45 57 Registers—damage or loss 45 58 Transferring responsibility for community pharmacies—stocktake etc of controlled medicines 47 59 Packaging of supplied regulated substances 50 60 Labelling of supplied regulated substances 51 61 Storing declared substances 52 Division 4.3.3 Containers—offences 62 Permanently named containers—use for other regulated substances 52 63 Certain containers not to be used for human-use substances 53 64 False statements to obtain certain regulated substances etc 53 65 Falsely representing substance is regulated 55 66 Advertising controlled medicines and prohibited substances 56 67 Meaning of vending machine—div 4.3.5 57 68 Vending machines—use for supply of regulated substances 57 69 Vending machines—use for supply of unscheduled medicines 58 70 Manufacture, supply and use of paints containing white lead 59 71 Manufacture, supply and use of paints for certain purposes 60 72 Manufacture, supply and use of paints for toys 60 73 Manufacture, supply and use of paints containing pesticides 60

Page contents 5 Chapter 5 Offences relating to regulated therapeutic 74 Supplying regulated therapeutic goods 62 75 Contravening authorisation conditions for regulated therapeutic goods 63 76 Pretending to be authorised to deal with regulated therapeutic goods 63 77 Falsely representing thing is regulated 63 Chapter 6 Licences for regulated substances and 78 Meaning of licence etc—ch 6 65 79 Meaning of close associate—ch 6 65 80 Meaning of influential person for corporation—ch 6 66 81 Suitability of individuals for licences 67 82 Suitability of corporations for licences 69 83 Power to ask for information etc from applicants and others 70 84 Applications for licences 72 85 Decision on applications for licences 72 86 Term of licences 73 87 Licences not transferable 73 88 Form of licences 73 89 Statutory licence conditions 74 90 Other licence conditions 74 91 Amending licence on chief health officer’s initiative 75 92 Amending licence on application by licence-holder 76 93 Licensee to keep chief health officer informed 76 94 Returning licences for amendment 77 95 Replacing licences 78 Part 6.3 Licences—other provisions 96 Contravening licence conditions 79

Page contents 6 Medicines, Poisons and Therapeutic Goods Act 2008 97 Surrendering licences 79 97A Meaning of monitored medicine 80 97B Definitions—ch 6A 80 97C Monitored medicines database—purposes 81 97D Monitored medicines database—scope 81 97E Monitored medicines database—chief health officer functions 82 97F Monitored medicines database—access and use by relevant health practitioners 83 97G Monitored medicines database—access authority 83 97H Monitored medicines database—offences 84 98 Definitions—pt 7.1 86 99 Meaning of medicines and poisons inspector—Act 86 Division 7.1.2 Medicines and poisons inspectors 100 Appointment of medicines and poisons inspectors 87 101 Identity cards 87 102 Power to enter premises 88 103 Production of identity card 89 104 Consent to entry 89 105 General powers on entry to premises 90 106 Power to seize things 91 107 Power to destroy unsafe things 92 108 Power to require name and address 94 109 Warrants generally 94 110 Warrants—application made other than in person 96

Page contents 7 111 Search warrants—announcement before entry 97 112 Details of search warrant to be given to occupier etc 98 113 Occupier entitled to be present during search etc 98 114 Moving things to another place for examination or processing 99 115 Use of electronic equipment at premises 100 116 Person with knowledge of computer to assist access etc 101 117 Securing electronic equipment 102 118 Copies of seized things to be provided 104 119 Receipt for things seized 105 120 Access to things seized 105 121 Return of things seized 106 122 Application for order disallowing seizure 107 123 Order for return of seized thing 108 124 Adjournment pending hearing of other proceedings 109 125 Forfeiture of seized things 109 126 Return of forfeited things 110 127 Cost of disposal of forfeited things 110 Division 7.1.6 Medicines and poisons inspectors—other provisions 128 Disposal etc of things obtained otherwise than under pt 7.1 111 129 Damage etc to be minimised 111 130 Compensation for exercise of enforcement powers 112 Part 7.2 Taking and analysis of samples of 131 Inspector may buy samples without complying with pt 7.2 113 132 Person in charge etc to be told sample to be analysed 113 133 Payment for samples 114 134 Samples from packaged substances 114 135 Procedures for dividing samples 114 136 Exception to usual procedures for dividing samples 115 137 Certificates of analysis by authorised analysts 116

Page contents 8 Medicines, Poisons and Therapeutic Goods Act 2008 Chapter 8 Restrictions on dealing with regulated substances and regulated therapeutic goods 138 Application—pt 8.1 117 139 Definitions—pt 8.1 118 140 Grounds for disciplinary action against authorisation holders 118 141 Disciplinary action against authorisation holders 120 142 Taking disciplinary action against authorisation holders 122 143 Immediate suspension of authorisations 123 144 Effect of suspension of authorisations 124 145 Return of certain licences and approvals 125 146 Action by chief health officer in relation to certain licences and approvals 125 Part 8.2 Controlled medicines and prohibited substances—disqualification by courts 147 Definitions—pt 8.2 127 148 Drug offences—disqualification from dealing 127 149 Notice of disqualification from dealing 128 150 Effect of disqualification from dealing 128 Part 8.3 Surrender of prescribed authorisations 151 Application—pt 8.3 129 152 Surrender of authorisation under regulation 129 153 Effect of surrender of authorisation under regulation 130 Chapter 9 Notification and review of decisions 154 Meaning of reviewable decision—ch 9 131 155 Reviewable decision notices 131 155A Applications for review 131

Page contents 9 Chapter 10 Incorporation of Commonwealth therapeutic 156 Definitions—ch 10 132 Part 10.2 Application in ACT of Commonwealth therapeutic goods laws 157 Application of Commonwealth therapeutic goods laws to ACT 134 158 Interpretation of Commonwealth therapeutic goods laws 134 Division 10.2.2 Functions under applied provisions 159 Functions of Commonwealth Minister 135 160 Functions of Commonwealth Secretary 135 161 Functions of other people 135 162 Delegations by Commonwealth Minister or Secretary 135 163 Appointments under Commonwealth therapeutic goods laws 136 Division 10.2.3 Applied provisions—administrative law matters 164 Application of Commonwealth administrative laws to applied provisions 136 165 Functions given to Commonwealth officers and authorities 137 166 Object—div 10.2.4 137 167 Application of Commonwealth criminal laws to offences against applied provisions 138 168 Functions of Commonwealth officers and authorities relating to offences 139 169 No double jeopardy for offences against applied provisions 139 170 Commonwealth may keep fees paid to Commonwealth Secretary 140

Page contents 10 Medicines, Poisons and Therapeutic Goods Act 2008 Part 11.1 General provisions about offences against Act 171 Acts and omissions of representatives of individuals 141 172 Criminal liability of executive officers 143 173 No defence to claim deterioration of sample 146 174 Remedial orders by court for offences 146 175 Court may order costs and expenses 147 176 Court may order forfeiture 147 177 Notices of noncompliance by territory entities 147 178 Evidence—authorisations under Commonwealth and State laws 149 179 Presumptions 149 180 Certificate evidence etc 150 181 Admissibility of analysis of samples taken by inspectors 151 182 Power of court to order further analysis 151 Chapter 12 Regulations about regulated substances and 183 Meaning of regulated thing—ch 12 153 184 Regulation-making power 153 185 Regulations—regulated things 153 186 Regulations—authorisations 154 187 Regulations—records kept electronically 155 188 Regulations—medicines advisory committee 156 189 Regulations—application etc of instruments 156 190 Regulations—exemption of people, dealings etc 156 191 Directions about dealings with regulated substances and therapeutic goods 158

Page contents 11 192 Guidelines about dealings with regulated substances and therapeutic goods 159 193 Approval of non-standard packaging and labelling 159 194 Establishment of medicines advisory committee 159 195 Secrecy 159 196 Protection of officials from liability 161 197 Determination of fees 161 Schedule 1 Reviewable decisions 162 Dictionary 165 1 About the endnotes 173 2 Abbreviation key 173 3 Legislation history 174 4 Amendment history 179 5 Earlier republications 187

An Act to consolidate and reform the law relating to regulated substances and regulated therapeutic goods, to give effect to the medicines and poisons standard, and for other purposes

1 Name of Act This Act is the Medicines, Poisons and Therapeutic Goods Act 2008.

3 Dictionary The dictionary at the end of this Act is part of this Act. Note 1 The dictionary at the end of this Act defines certain terms used in this Act, and includes references (signpost definitions) to other terms defined elsewhere in this Act. For example, the signpost definition ‘authorisation holder, for part 8.1 (Authorisations—disciplinary action)—see section 139.’ means that the term ‘authorisation holder’ is defined in that section for part 8.1. Note 2 A definition in the dictionary (including a signpost definition) applies to the entire Act unless the definition, or another provision of the Act, provides otherwise or the contrary intention otherwise appears (see Legislation Act, s 155 and s 156 (1)).

4 Notes A note included in this Act is explanatory and is not part of this Act. Note See the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.

5 Offences against Act—application of Criminal Code etc Other legislation applies in relation to offences against this Act. Note 1 Criminal Code The Criminal Code, ch 2 applies to all offences against this Act (see Code, pt 2.1). The chapter sets out the general principles of criminal responsibility (including burdens of proof and general defences), and defines terms used for offences to which the Code applies (eg conduct, intention, recklessness and strict liability). Note 2 Penalty units The Legislation Act, s 133 deals with the meaning of offence penalties that are expressed in penalty units.

Operation of Act Chapter 2

6 Objects (1) The main object of this Act is to promote and protect public health and safety by minimising— (a) accidental and deliberate poisonings by regulated substances; and (b) medicinal misadventures related to regulated substances; and (c) the diversion of regulated substances for abuse; and (d) the manufacture of regulated substances that are subject to abuse; and (e) harm from regulated therapeutic goods. (2) The objects of this Act also include ensuring that— (a) consumers of prescription medicines have adequate information and the understanding necessary to allow them to use the medicines safely and effectively; and (b) consumers of non-prescription medicines have adequate information and the understanding to allow them to select the most appropriate medicines for their condition and to use the medicines safely and effectively, taking into account the condition of their health. (3) In regulating the dealings of health practitioners or veterinary practitioners with regulated substances, the chief health officer may, but need not, choose to take disciplinary action rather than pursuing prosecutions under this Act if the chief health officer believes it would be in the public interest to do so.

non-prescription medicine means a medicine other than a prescription medicine. prescription medicine means a prescription only medicine or controlled medicine.

7 Appropriate prescription and supply of medicines (1) A health practitioner or a veterinary practitioner who prescribes or supplies a medicine must ensure that the prescription or supply of the medicine is for a quantity and purpose that is consistent with the recognised therapeutic standard of what is appropriate in the circumstances. (2) Subsection (1) does not apply to wholesale supply.

8 Obligations under other territory laws The obligations under this Act are additional to the obligations under any other territory law unless this Act, or the other law, provides otherwise. If there is an obligation under the Dangerous Substances Act 2004 and under this Act in relation to a particular substance, both obligations must be complied with in relation to the substance unless either Act provides otherwise.

9 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.

Operation of Act Chapter 2

9A Application of Act to certain cannabis use not prohibited under Drugs of Dependence Act 1989 (1) The defined provisions of this Act do not apply to an adult to the extent that the substance is an amount of cannabis that the adult is not prohibited from cultivating or possessing under the Drugs of Dependence Act 1989. defined provisions of this Act means the following: (a) section 26 (2) (Supplying declared substances); (b) section 33 (Manufacturing regulated substances); (c) section 35 (1) (Obtaining certain declared substances); (d) section 36 (Possessing certain declared substances); (e) section 37 (2) (Administering certain declared substances).

10 Meaning of regulated substance—Act regulated substance means a medicine, poison, prohibited substance or schedule 10 substance.

11 Medicine-related definitions medicine means— (a) a pharmacy medicine; or (b) a pharmacist only medicine; or (c) a prescription only medicine; or (d) a controlled medicine. (2) In this Act: controlled medicine means a substance to which the medicines and poisons standard, schedule 8 applies. Note Schedule 8 medicines are prescription medicines that have additional restrictions to reduce misuse or dependence. The schedule includes some derivatives of the scheduled medicines (see s 16 (2)). pharmacist only medicine means a substance to which the medicines and poisons standard, schedule 3 applies. Note Schedule 3 medicines are medicines that require advice from a pharmacist to be used safely. The schedule includes some derivatives of the scheduled medicines (see s 16 (2)).

Substances to which Act applies Part 3.1 pharmacy medicine means a substance to which the medicines and poisons standard, schedule 2 applies. Note Schedule 2 medicines are medicines that may require advice from a pharmacist to be used safely. The schedule includes some derivatives of the scheduled medicines (see s 16 (2)). prescription only medicine means a substance to which the medicines and poisons standard, schedule 4 applies. Note Schedule 4 medicines are medicines (including prescription animal remedies) that are available from a pharmacy on prescription. The schedule includes some derivatives of the scheduled medicines

12 Poison-related definitions poison means— (a) a low harm poison; or (b) a moderate harm poison; or (c) a dangerous poison. (2) In this Act: dangerous poison means a substance to which the medicines and poisons standard, schedule 7 applies. Note Schedule 7 applies to substances with a high potential for causing harm. The schedule includes some derivatives of the scheduled substances low harm poison means a substance to which the medicines and poisons standard, schedule 5 applies. Note Schedule 5 applies to substances with a low potential for causing harm. The schedule includes some derivatives of the scheduled substances

moderate harm poison means a substance to which the medicines and poisons standard, schedule 6 applies. Note Schedule 6 applies to substances with a moderate potential for causing harm. The schedule includes some derivatives of the scheduled substances (see s 16 (2)).

13 Meaning of prohibited substance and schedule 10 substance—Act prohibited substance— (a) means a substance to which the medicines and poisons standard, schedule 9 applies; but (b) does not include cannabis food products. Note Sch 9 substances are generally illegal substances that are subject to abuse. They include some derivatives of the scheduled substances (see s 16 (2)). schedule 10 substance means a substance to which the medicines and poisons standard, schedule 10 applies. Note Sch 10 substances are substances, other than those in sch 9, the sale, supply and use of which is prohibited because of the degree of danger to health they represent. The schedule includes some derivatives of the substances to which the schedule applies (see s 16 (2)). cannabis food product—see the Drugs of Dependence Act 1989, section 6.

Therapeutic goods to which Act applies Part 3.2

Part 3.2 Therapeutic goods to which Act applies

14 Meaning of regulated therapeutic good—Act regulated therapeutic good means— (a) any of the following within the meaning of the Therapeutic Goods Act 1989 (Cwlth) as prescribed by regulation: (i) a therapeutic good (other than a regulated substance); (ii) a medical device; or (b) anything else (other than a regulated substance) prescribed by

15 Meaning of medicines and poisons standard—Act medicines and poisons standard means the poisons standard, as in force from time to time and as modified by regulation (if any). Note For the public availability and inspection of a copy of the medicines and poisons standard, see s 18. (2) For subsection (1), but subject to any modification prescribed by regulation, an amendment of a current poisons standard or a new poisons standard takes effect in accordance with the Legislation Act 2003 (Cwlth), section 12. current poisons standard—see the Therapeutic Goods Act 1989 (Cwlth), section 52A (1), definition of current Poisons Standard. new poisons standard means a document prepared under the Therapeutic Goods Act 1989 (Cwlth), section 52D (2) (b). poisons standard means a document made under the Therapeutic Goods Act 1989 (Cwlth), section 52D (2).

16 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.

Medicines and poisons standard Part 3.3 (2) A provision of the medicines and poisons standard relating to the interpretation of the standard applies in the interpretation of this Act. If the medicines and poisons standard provides that, subject to stated exceptions, a reference to a substance in a schedule or appendix to the standard includes every salt, active principle or derivative of the substance, then a reference to the substance in this Act includes, subject to the exceptions, a reference to each salt, active principle or derivative of the substance.

17 When medicines and poisons standard applies to For this Act, a schedule or appendix of 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) an exclusion in the standard does not, in the circumstance, exclude the substance from the operation of the schedule or appendix; or (ii) if a restriction is mentioned in the standard for the substance—the restriction applies in relation to the substance in the circumstance. Example—par (b) (ii) Substance X is included in sch 4 (Prescription only medicine) of the medicines and poisons standard. Its listing is followed by the restriction ‘for human therapeutic use’. Substance X is not included in another schedule or an appendix of the standard. The standard applies to substance X only for human therapeutic use. Note See also s 9 (Inconsistency between Act and medicines and poisons standard).

18 Inspection of medicines and poisons standard The chief health officer must ensure that a copy of the medicines and poisons standard (including any amendments of the standard) is made available for inspection free of charge to the public on business days at reasonable times at an office administered by the chief health officer.

19 Meaning of deals with a regulated substance—Act (1) For this Act, a person deals with a regulated substance if the person does 1 or more of the following: (a) manufactures the substance; (b) obtains the substance; (c) possesses the substance; (d) supplies the substance; (e) administers the substance; (f) discards the substance; (g) issues a purchase order for the substance; (h) if the substance is a medicine— (i) prescribes the medicine; or (ii) issues a requisition or standing order for the medicine; (i) if the substance is a dangerous poison, prohibited substance or schedule 10 substance—gives a written or oral direction to— (i) supply the poison or substance for administration to a person; or (ii) administer the poison or substance to a person. (2) For this Act, a person also deals with a regulated substance if the regulated substance otherwise comes into, or goes out of, the person’s possession, including, for example, if the person loses or finds the regulated substance or the substance is stolen from the person.

20 When authorised to deal with regulated substances (1) For this Act, a person is authorised to deal with a medicine, low harm poison or moderate harm poison if— (a) the person has a licence or permit under a Commonwealth Act, this Act or another territory law that authorises the dealing; or Note A reference to an Act includes a reference to statutory instruments made or in force under the Act, including any regulation and any law or instrument applied, adopted or incorporated by the Act (see Legislation Act, s 104). (b) the person may or must deal with the medicine or poison under a Commonwealth Act, this Act or another territory law; or (c) the chief health officer approves the dealing under a regulation; or (d) the dealing is otherwise authorised by regulation. Examples of Commonwealth Acts—pars (a) and (b) Customs (Prohibited Imports) Regulations 1956, Narcotic Drugs Act 1967 and Therapeutic Goods Act 1989 Examples of when person may or must deal with medicines—par (b) 1 the person is a dentist and a regulation allows dentists to administer the medicine 2 the person is authorised under the Health Professionals (Special Events Exemptions) Act 2000, s 10 (1) to issue a written prescription for the medicine 3 the person is authorised under the Voluntary Assisted Dying Act 2024, s 66 to administer the medicine Note For the supply of a regulated substance by wholesale, see s (4). (2) For this Act, a person is authorised to deal with a dangerous poison, prohibited substance or schedule 10 substance if— (a) the person may or must deal with the poison or substance under a Commonwealth Act, this Act or another territory law; or (b) the person has a licence under this Act that authorises the dealing.

(3) However, for subsection (2), a person is authorised for an administration-related dealing with a dangerous poison, prohibited substance or schedule 10 substance for human use only if— (a) the dealing is authorised by a licence for the purposes of research at a recognised research institution; and (b) the research is approved by a human research ethics committee that is constituted in accordance with, and acting in compliance with, the NHMRC National Statement on Ethical Conduct in Research Involving Humans (1999), as in force from time to time. Note Administration-related dealing, NHMRC and recognised research institution—see s (5). (4) Also, for this Act, a person is authorised to supply a regulated substance by wholesale if— (a) the person is authorised (however described) under a corresponding law to supply the substance by wholesale; and (b) the person does not have a place of business in the ACT; and (c) if a condition or restriction applies to the person under the corresponding law or is prescribed by regulation—the person complies with each condition or restriction; and (d) the chief health officer has not, under part 8.1 (Authorisations— disciplinary action), prohibited the person from supplying the substance by wholesale in the ACT. Note Wholesale—see the dictionary.

administration-related dealing, in relation to a dangerous poison, prohibited substance or schedule 10 substance for human use, means— (a) giving a written or oral direction to administer the poison or substance, or supply the poison or substance for administration, to a person; or (b) supplying the poison or substance for administration to a person; or (c) administering the poison or substance to a person. NHMRC means the National Health and Medical Research Council under the National Health and Medical Research Council Act 1992 (Cwlth). recognised research institution means any of the following: (a) the Australian Catholic University; (b) the Australian National University; (c) a hospital operated by the Territory; (d) the Canberra Institute of Technology; (e) the Commonwealth Scientific and Industrial Research Organisation; (f) the University College within the Australian Defence Force Academy; (g) the University of Canberra; (h) any other entity prescribed by regulation.

21 Meaning of deals with a regulated therapeutic good—Act For this Act, a person deals with a regulated therapeutic good if the person supplies the good.

22 When authorised to deal with regulated therapeutic (1) For this Act, a person is authorised to deal with a regulated therapeutic good if— (a) the person has a licence or permit under a Commonwealth Act, this Act or another territory law that authorises the dealing; or (b) the person may or must deal with the good under a Commonwealth Act, this Act or another territory law; or Note A reference to an Act includes a reference to statutory instruments made or in force under the Act, including any regulation and any law or instrument applied, adopted or incorporated by the Act (see Legislation Act, s 104). (c) the chief health officer approves the dealing under a regulation; or (d) the dealing is otherwise authorised by regulation. (2) Also, for this Act, a person is authorised to supply a regulated therapeutic good by wholesale if— (a) the person is authorised (however described) under a corresponding law to supply the good by wholesale; and (b) the person does not have a place of business in the ACT; and (c) if a condition or restriction applies to the person under the corresponding law or is prescribed by regulation—the person complies with each condition or restriction; and

(d) the chief health officer has not, under part 8.1 (Authorisations— disciplinary action), prohibited the person from supplying the good by wholesale in the ACT. Note Wholesale—see the dictionary.

23 Meaning of supply authority—Act supply authority—each of the following is a supply authority: (a) a written prescription; (b) a written requisition; (c) a purchase order; (d) a standing order; (e) a document that purports to be a document mentioned in paragraph (a), (b), (c) or (d). Note A purchase order and standing order must be in writing (see the definitions of these terms in the dictionary).

24 Meaning of possess, sell and supply—Act possess, for a regulated substance, includes the following: (a) receive or obtain possession of the substance; (b) have control over the disposition of the substance (whether with or without custody of the substance); (c) have joint possession of the substance. sell includes the following: (a) offer or expose for sale;

(b) dispose of by any method for value (or offer or expose for disposal by any method for value); (c) possess for sale or disposal for value. supply— (a) includes the following: (i) sell (or offer or expose for sale); (ii) dispense; Note Dispense means supply on prescription (see dict). (iii) supply under a requisition or standing order; (iv) dispose of by any method for free (other than by discarding); but (b) does not include administer.

Chapter 4 Offences relating to regulated Part 4.1 Dealings with regulated substances—offences 25 Meaning of declared substance—pt 4.1 declared substance means— (a) a medicine; or (b) a dangerous poison; or (c) a prohibited substance; or (d) a schedule 10 substance; or (e) a low harm poison, or moderate harm poison, prescribed by 26 Supplying declared substances (a) the person supplies a declared substance to someone else; and (b) the person is not authorised to supply the substance to the other Note Supply includes sell or offer to sell (see s 24).

(a) the person supplies a declared substance to themself; and (b) the person is not authorised to supply the substance to themself.

27 Supplying declared substances on invalid supply authorities—strict liability offences (a) the person is authorised to supply a declared substance on a (b) the person supplies the declared substance on a supply authority; and (c) 1 or more of the following apply in relation to the supply (i) all or part of the authority is illegible; (ii) the authority has been changed; (iii) the authority has been marked ‘cancelled’; (iv) for a supply authority for a declared substance that is a controlled medicine—the authority is issued more than 6 months before the date the substance medicine is supplied; (v) for a supply authority for a declared substance other than a controlled medicine—the authority is issued more than 1 year before the date the substance is supplied.

(2) Subsection (1) (c) (i) and (ii) do not apply in relation to the supply of a declared substance by a person if, before the supply, the person checks the content of the supply authority with the person who issued the authority (the issuer) and— (a) the supply is in accordance with the authority as confirmed by the issuer; or (b) if the authority is a prescription— (i) the authority is changed by a pharmacist at the oral direction of the issuer; and (ii) the pharmacist notes the change on the authority as (iii) the supply is in accordance with the authority as changed. (3) Subsection (1) does not apply to an employee or agent of a person (the principal) if the employee or agent supplies the declared substance at the direction of the principal. (4) To remove any doubt, subsection (3) does not affect the principal’s liability for the offence under section 171 (Acts and omissions of representatives of individuals). (5) An offence against subsection (1) is a strict liability offence.

28 Supplying declared substances on invalid supply authorities—recklessness A person (the supplier) commits an offence if— (a) a supply authority is issued by a person who is not authorised to issue the authority; and (b) the supplier supplies a declared substance on the supply authority; and

(c) the supplier is reckless about whether the supply authority is issued by someone who is not authorised to issue it.

29 Supplying declared substances on invalid supply authorities—other offences (a) the person supplies a declared substance on a supply authority; and (b) 1 or more of the following apply in relation to the supply (i) the person knows the authority was obtained because of false information given to the person (the issuer) who issued the authority; (ii) the person could reasonably believe that the authority has been changed by someone other than the issuer; (iii) the person could reasonably believe that the authority is false in a material particular. (2) However, subsection (1) (b) (ii) does not apply to the supply of a declared substance by a person if— (a) before supplying the substance, the person checks whether the change to the supply authority was made by the issuer; and (b) the issuer confirms the change.

(3) Further, subsection (1) (b) (ii) does not apply to the supply of a declared substance on a prescription or requisition if— (a) before the substance is supplied by the person, the prescription or requisition is changed at the oral direction of the issuer; and (b) the person notes the change on the prescription or requisition as prescribed by regulation.

30 Cancellation etc of invalid supply authorities for declared relevant circumstance, in relation to a supply authority given to a person to supply a declared substance, means— (a) all or part of the authority is illegible; or (b) all or part of the authority has been obliterated; or (c) 1 or more of the following apply in relation to the supply (i) the supply authority was issued by someone who was not authorised to issue it; (ii) the person knows the authority was obtained because of false information given to the person (the issuer) who issued the authority; (iii) the person could reasonably believe that the authority has been changed by someone other than the issuer; (iv) the person could reasonably believe that the authority is false in a material particular; (v) the person could reasonably believe that the supply authority is a forgery.

(a) the person is authorised to supply a declared substance on a (b) the person is given a supply authority for the supply of the (c) a relevant circumstance applies in relation to the authority; and (d) the person does not cancel the authority as prescribed by Note For how long a cancelled supply authority must be kept, see s 47.

31 Supply of certain declared substances—information for chief health officer (a) the person supplies any of the following on a supply authority: (i) a monitored medicine; (ii) a declared substance (other than a monitored medicine) (b) the person does not give the chief health officer the required information as prescribed by regulation. (a) the person supplies any of the following otherwise than on a supply authority: (i) a monitored medicine;

(ii) a declared substance (other than a monitored medicine) (b) the person does not give the chief health officer the required information as prescribed by regulation. (3) Strict liability applies to subsection (1) (b) and subsection (2) (b). required information means the information prescribed by

32 Information about invalid supply authorities for chief health officer (a) the person cancels a supply authority for a declared substance prescribed by regulation for section 30 (Cancellation etc of invalid supply authorities for declared substances); and (b) the declared substance is— (i) a prescription only medicine; or (ii) a controlled medicine; or (iii) a dangerous poison; or (iv) another declared substance prescribed by regulation; and (c) either— (i) the person fails to tell the chief health officer and a police officer about the authority and the reason for cancelling the authority immediately after cancelling it; or

(ii) not later than 24 hours after the relevant circumstance under section 30 happens, the person fails to— (A) tell the chief health officer, in writing, about the reason; and (B) give the chief health officer a copy of the cancelled authority. (a) the person supplies a declared substance on a supply authority; and (b) the declared substance is— (i) a prescription only medicine; or (ii) a controlled medicine; or (iii) a dangerous poison; or (iv) another declared substance prescribed by regulation; and (c) after the person supplies the substance the person becomes aware of any of the following (the designated circumstance): (i) the supply authority was issued by someone who was not authorised to issue it; (ii) the supply contravened a provision of— (A) section 27 (1) (c) (Supplying declared substances on invalid supply authorities—strict liability offences); or (B) section 29 (1) (b) (Supplying declared substances on invalid supply authorities—other offences); and

(d) either— (i) the person fails to tell the chief health officer and a police officer about the supply authority immediately after the person becomes aware of the designated circumstance; or (ii) not later than 24 hours after the person becomes aware of the designated circumstance, the person fails to— (A) tell the chief health officer, in writing, about the (B) give the chief health officer a copy of the authority. (3) A person must not be prosecuted for an offence under subsection (2) involving a contravention of section 27 (1) (c) or section 29 (1) (b) if— (a) at the time the person supplied the declared substance on the supply authority the person believed on reasonable grounds that no designated circumstance applied in relation to the supply authority; and (b) the person does not contravene subsection (2).

Division 4.1.3 Regulated substances—other dealings

33 Manufacturing regulated substances (a) the person manufactures a regulated substance; and (b) the person is not authorised to manufacture the substance.

34 Discarding declared etc substances (a) a regulation prescribes how a declared substance must be discarded; and (b) the person discards the substance; and (c) the person does not discard the substance as prescribed. (a) the person possesses a declared substance; and (b) the chief health officer gives the person a direction under section 191 (Directions about dealings with regulated substances and therapeutic goods) in relation to the discarding of the substance; and (c) the person does not discard the substance as directed.

(3) A person commits an offence if the person discards a declared substance in a way that— (b) is likely to cause damage to property or the environment. Note The Dangerous Substances Act 2004, Environment Protection Act 1997 and Work Health and Safety Act 2011 may also apply to the discarding of a regulated substance. (4) However, subsection (3) does not apply if the declared substance is discarded in accordance with— (a) a regulation about how the substance must be discarded; or (b) a direction by the chief health officer under section 191. (5) A person commits an offence if— (a) the person discards a low harm poison or moderate harm poison; and (b) the poison is not a declared substance; and (c) the discarding— (i) puts the health or safety of people at risk; or (ii) causes damage to property or the environment. Note The Dangerous Substances Act 2004, Environment Protection Act 1997 and Work Health and Safety Act 2011 may also apply to the discarding of a regulated substance.

35 Obtaining certain declared substances (a) the person obtains a declared substance that is— (i) a pharmacy medicine, or pharmacist only medicine, prescribed by regulation; or (ii) a prescription only medicine; or (iii) a controlled medicine; or (iv) a dangerous poison; or (v) a prohibited substance; and (b) the person is not authorised to obtain the substance. (a) the person obtains a prescription only medicine; and (b) the person is not authorised to obtain the medicine.

36 Possessing certain declared substances (a) the person possesses a declared substance that is— (i) a pharmacy medicine, or pharmacist only medicine, prescribed by regulation; or (ii) a prescription only medicine; or (iii) a controlled medicine; or

(iv) a dangerous poison; or (v) a prohibited substance; and (b) the person is not authorised to possess the substance.

37 Administering certain declared substances pharmacy medicine or pharmacist only medicine) to someone else; and (b) the person is not authorised to administer the substance to the other person. pharmacy medicine or pharmacist only medicine) to themself; and (b) the person is not authorised to administer the substance to themself. (3) A person does not commit an offence under the Criminal Code, section 45 (Complicity and common purpose) in relation to an offence committed by another person under subsection (1) or (2) of this section only because the person supplies sterile injecting equipment to the other person for the purpose of preventing the spread of blood-borne disease.

(4) A person commits an offence if— pharmacy medicine or pharmacist only medicine) to an animal; and (b) the person is not authorised to administer the substance to the animal.

38 Issuing purchase orders for declared substances (a) the person issues a purchase order for a declared substance; and (b) the person is not authorised to issue the purchase order for the (a) the person is authorised to issue a purchase order for a declared (b) the person issues a purchase order for the substance; and (c) the purchase order does not comply with the requirements prescribed by regulation.

39 Reporting loss and theft of certain regulated substances reportable substance means— (a) a controlled medicine; or (b) a dangerous poison; or (c) a prohibited substance; or (d) a schedule 10 substance; or (e) another regulated substance prescribed by regulation. (a) the person is authorised to possess a reportable substance; and (b) the person possesses the substance; and (c) the substance is lost or the person suspects that the substance has been lost; and (d) the person fails to tell the chief health officer, in writing, about the loss or suspected loss and how it happened as soon as practicable (but not later than 7 days) after the day the person becomes aware of the loss or suspected loss. (a) the person is authorised to possess a reportable substance; and (b) the person possesses the substance; and (c) the substance is stolen or the person suspects that the substance has been stolen; and

(d) the person fails to tell the chief health officer and a police officer about the theft or suspected theft— (i) orally immediately after the person becomes aware of the theft or suspected theft; and (ii) in writing not later than 24 hours after the person becomes aware of the theft or suspected theft.

40 Prescribing medicines for someone else; and (b) the person is not authorised to prescribe the medicine for the other person. for themself; and (b) the person is not authorised to prescribe the medicine for themself. for an animal; and

(b) the person is not authorised to prescribe the medicine for the animal.

41 Issuing requisitions for medicines (a) the person issues a requisition for a medicine (whether orally or in writing); and (b) the person is not authorised to issue the requisition.

42 Issuing standing orders for medicines (a) the person issues a standing order for a medicine; and (b) the person is not authorised to issue the standing order.

43 Medicines for animals not to be prescribed etc for human use (a) the person prescribes a medicine for human use; and (c) the person is not authorised to prescribe the medicine for human use. (a) the person supplies a medicine for human use; and (c) the person is not authorised to supply the medicine for human use. Note Supply includes dispense (see s 24). (a) the person administers a medicine to themself or someone else; and

(c) the person is not authorised to administer the medicine for human use.

44 Contravening authorisation conditions for regulated (a) the person is authorised to deal with a regulated substance; and (c) the person is reckless about whether the dealing contravenes the condition. (a) the person is authorised to deal with a regulated substance; and (c) the person contravenes the condition. Note 1 For examples of conditions that might be prescribed by regulation, see s 186. Note 2 A reference to an Act includes a reference to the statutory instruments

Dealings—other offences Division 4.1.4

45 Pretending to be authorised to deal with regulated substance (1) A person commits an offence if the person pretends to be authorised to deal with a regulated substance. (2) A person commits an offence if the person pretends to be authorised to deal with a regulated substance.

Part 4.2 Records for regulated substances—offences

46 Accessibility of records (a) the person is required under this Act to record something in relation to a regulated substance; and (b) the person does not record the thing— (i) in writing; and (ii) in English; and (iii) in a way that is easily retrievable. Note 1 Written includes in electronic form (see dict). Note 2 A reference to an Act includes a reference to statutory instruments made

47 Keeping cancelled invalid supply authorities (a) the person cancels a supply authority under section 30 (Cancellation etc of invalid supply authorities for declared substances); and (b) the person fails to ensure that the cancelled supply authority is kept for at least 2 years after the day the person cancels the supply authority. (2) Subsection (1) does not apply to a person if— (a) the person is required under this Act to give the supply authority to the chief health officer or a police officer; or (b) either the chief health officer or a police officer requires the person to give the supply authority to the chief health officer or police officer. (3) An offence against subsection (1) is a strict liability offence.

48 Meaning of must keep register—div 4.2.2 For this division, a person must keep a register for a regulated substance— (a) if the person is prescribed by regulation for the substance; or (b) if— (i) the person is a pharmacist who is responsible for the management of a community pharmacy; and (ii) controlled medicines are kept at the pharmacy. Note Community pharmacy—see the dictionary.

49 Registers—not keeping (b) the person does not keep the register as prescribed by regulation. (b) the person does not keep the register as prescribed by regulation.

50 Registers—where to be kept (b) a regulation prescribes a place to keep the register; and (c) the person fails to keep the register at the place prescribed. (b) a regulation prescribes a place to keep the register; and (c) the person fails to keep the register at the place prescribed.

51 Registers—duty to ensure entries made (1) A person (the principal) who must keep a register for a regulated substance commits an offence if— (a) the principal, or an employee or agent of the principal, deals with the regulated substance; and (b) the principal fails to ensure that the details prescribed by regulation for the dealing are entered in the register prescribed by regulation as soon as practicable (but not later than 24 hours) after the dealing happens. (2) An offence against subsection (1) is a strict liability offence.

52 Registers—signing entries (a) the person makes an entry in a register for a regulated substance; and (b) the person fails to sign the entry as soon as practicable (but not later than 24 hours) after the entry is made.

53 Registers—witnessing administration of medicines (a) a regulated substance is prescribed by regulation; and (b) the person is prescribed by regulation as a witness in relation to the administration of the substance; and

(c) the person witnesses the administration of the medicine; and (d) the administration of the medicine is entered in a register for the medicine; and (e) the person fails to sign the entry in the register as witness as soon as practicable (but not later than 24 hours) after the entry is made.

54 Registers—witnessing discarding (a) a regulated substance is prescribed by regulation; and (b) the person is prescribed by regulation as a witness in relation to the discarding of the substance; and (c) the person witnesses the discarding of the substance; and (d) the discarding of the substance is entered in the register for the (e) the person fails to sign the entry in the register as witness as soon as practicable (but not later than 24 hours) after the entry is made.

55 Registers—changes etc to entries (1) A person commits an offence if the person cancels, changes, deletes or obliterates an entry in a register for a regulated substance. (2) However, subsection (1) does not apply to a person if the person— (a) made the entry in the register; and (b) amends the entry as prescribed by regulation. Note It is an offence to produce a document in compliance with a territory law if the document is false or misleading in a material particular (see Criminal Code, s 339).

56 Registers—period to be kept (b) the person fails to ensure that the register is kept for at least 2 years after the day when the last entry is made in the register. Note For how long a register for a regulated substance kept electronically must be kept, see the Electronic Transactions Act 2001, s 11 and this Act, s 187.

57 Registers—damage or loss (b) the register is damaged in a material respect, stolen, lost or destroyed; and

(c) the person fails to tell the chief health officer, in writing, about the damage, theft, loss or destruction as soon as practicable (but not later than 7 days) after the day it happens. (b) the register is damaged in a material respect, stolen, lost or destroyed; and (c) the person does not take an inventory as prescribed by regulation of each regulated substance in the person’s possession to which the register related. Note Possess includes have control over disposition (see s 24). (3) This section does not apply to a register for a regulated substance if the most recent entry in the register is made more than 2 years before the day the register is damaged, stolen, lost or destroyed. material respect—a register for a regulated substance is damaged in a material respect if anything required to be entered in the register is missing or cannot be easily read.

58 Transferring responsibility for community pharmacies— stocktake etc of controlled medicines (1) A pharmacist (the responsible pharmacist) who is responsible for the management of a community pharmacy commits an offence if— (a) the pharmacist proposes to stop being responsible for the pharmacy for a continuous period of longer than 14 days; and (b) before the pharmacist stops being responsible for the pharmacy, the pharmacist fails to— (i) take a written inventory of each quantity of each form and strength of a controlled medicine held in the pharmacy; and (ii) enter each of the quantities in the controlled medicines register for the pharmacy; and (iii) sign and date each entry in the register. Note Community pharmacy and signs—see the dictionary. (2) A pharmacist commits an offence if— (a) the pharmacist intends to take responsibility for a community pharmacy for a continuous period of more than 14 days; and (b) before taking responsibility for the pharmacy, the pharmacist fails to— (i) check the entries made in the controlled medicines register for the pharmacy under subsection (1) (b) (ii); and (ii) for each of the entries in the register, indicate in writing whether the pharmacist agrees that the entry is a correct record of the quantity of the form and strength of the controlled medicine held in the pharmacy; and

(iii) sign and date each of the entries in the register. (3) The responsible pharmacist for a community pharmacy commits an offence if— (a) the pharmacist takes an inventory of controlled medicines held in the pharmacy; and (b) the quantity of a form and strength of a controlled medicine held at the pharmacy is not the quantity shown for the form and strength of the medicine in the controlled medicines register for the pharmacy; and (c) the pharmacist fails to take reasonable steps to resolve the discrepancy between— (i) the quantity of the form and strength of the controlled medicine held at the pharmacy; and (ii) the quantity shown in the register. (4) The responsible pharmacist for a community pharmacy commits an offence if— (a) the pharmacist takes an inventory of controlled medicines held in the pharmacy; and (b) the quantity of a form and strength of a controlled medicine held at the pharmacy is not the quantity shown for the form and strength of the medicine in the controlled medicines register for the pharmacy; and

(c) the pharmacist does not tell the chief health officer about the discrepancy— (i) orally immediately after checking the entries in the controlled medicines register; and (ii) in writing not later than 24 hours after finishing the check. controlled medicines register, for a community pharmacy, means a register for controlled medicines that a pharmacist must keep for the pharmacy under section 48 (Meaning of must keep register— div 4.2.2).

Part 4.3 Regulated substances—other offences

59 Packaging of supplied regulated substances (b) the person supplies the substance to someone else; and (c) the substance is not packaged— (ii) in accordance with an approval under section 193 (Approval of non-standard packaging and labelling). (b) the person supplies the substance to someone else; and (c) the substance is not packaged— (ii) in accordance with an approval under section 193. (3) This section does not apply to a regulated substance that is supplied for immediate administration to a person. (4) An offence against subsection (2) is a strict liability offence.

Packaging and labelling—offences Division 4.3.1

60 Labelling of supplied regulated substances (b) the person supplies a regulated substance to someone else; and (c) the substance is not labelled— (ii) in accordance with an approval under section 193 (Approval of non-standard packaging and labelling). (b) the person supplies a regulated substance to someone else; and (c) the substance is not labelled— (ii) in accordance with an approval under section 193. (3) This section does not apply to a regulated substance that is supplied for immediate administration to a person. (4) An offence against subsection (2) is a strict liability offence.

61 Storing declared substances (a) the person is authorised to possess a declared substance; and (b) the person is prescribed by regulation in relation to the (c) the person fails to store the substance as prescribed by Division 4.3.3 Containers—offences

62 Permanently named containers—use for other regulated (a) the person uses a container for a regulated substance; and (b) the container is permanently marked with the name of a different regulated substance.

Representations and advertisements—offences Division 4.3.4

63 Certain containers not to be used for human-use (a) the person supplies a human-use substance in a container; and (b) the container is of a kind prescribed by regulation. (2) For this section, each of the following substances is a human-use substance: (a) food; (b) a drink; (c) a condiment. Division 4.3.4 Representations and advertisements—offences

64 False statements to obtain certain regulated substances etc reportable substance—see section 39. (a) the person makes a statement to a person (the authorised person) who is authorised to administer or supply a reportable Note Supply includes dispense on prescription (see s 24). (b) the statement is false or misleading; and

(c) the person knows the statement— misleading; and (d) the person makes the statement for the purpose of obtaining the substance from the authorised person. (a) the person makes a statement to a person (the authorised person) who is authorised to issue a prescription or purchase order for a reportable substance; and (b) the statement is false or misleading; and (c) the person is reckless about whether the statement— misleading; and (d) the person makes the statement for the purpose of obtaining the prescription or purchase order from the authorised person. (4) A person commits an offence if— (a) the person states a name or home address to— (i) a person (the authorised person) authorised to dispense a reportable substance; or (ii) an employee or agent of an authorised person in the course of the employee’s or agent’s employment or agency; and

Representations and advertisements—offences Division 4.3.4 (b) the statement— misleading. (5) An offence against subsection (4) is a strict liability offence. (6) Subsections (2), (3) and (4) do not apply to the making of a statement if the statement is not false or misleading in a material particular. (7) Subsections (2), (3) and (4) do not apply to the omission of something from a statement if the omission does not make the statement not false or misleading in a material particular.

65 Falsely representing substance is regulated (1) A person (the supplier) commits an offence if— (a) the supplier supplies a substance as a particular regulated substance (the purported substance); and (b) the supplier knows that the substance is not the purported (2) A person (the supplier) commits an offence if— (a) the supplier supplies a substance as a particular regulated substance (the purported substance); and (b) the supplier is reckless about whether the substance is the purported substance.

66 Advertising controlled medicines and prohibited (a) the person publishes an advertisement; and (b) the advertisement promotes or encourages the use of a controlled medicine or prohibited substance. (a) the person publishes an advertisement; and (b) the advertisement indicates that someone is willing or authorised to supply a controlled medicine or prohibited substance. (3) This section does not apply to— (a) an advertisement for a controlled medicine in a publication published primarily for dentists, doctors, pharmacists or veterinary practitioners; or (b) an advertisement by a pharmacist prescribed by regulation; or (c) an advertisement prescribed by regulation. advertisement means writing, sound or a picture, symbol, light or other visible device, object or sign (or a combination of 2 or more of these) that a reasonable person would consider publicises, or otherwise promotes, the purchase or use of a controlled medicine or prohibited substance.

Vending machines—offences Division 4.3.5

67 Meaning of vending machine—div 4.3.5 In this division: vending machine means a machine or device from which regulated substances can be obtained, including by 1 or more of the following: (a) electronic funds transfer; (b) inserting money, a token or another object. Examples of other objects—par (b) 1 credit card 2 debit card 3 key

68 Vending machines—use for supply of regulated (a) the person is the occupier of premises; and (b) a vending machine is installed on the premises; and (c) the vending machine is used, or available for use, for the supply of a regulated substance by a person other than the occupier or an employee or agent of the occupier. (2) Subsection (1) does not apply if the vending machine was placed on the premises without the occupier’s consent.

69 Vending machines—use for supply of unscheduled medicines manufacturer’s pack, of an unscheduled medicine, means a primary pack of the medicine that has been packaged and labelled by the medicine’s manufacturer as prescribed by regulation. unscheduled medicine means a substance mentioned in the medicines and poisons standard, schedules 2, 3, 4 or 8 if none of the schedules apply to the substance because of an exception in the standard. Aspirin is mentioned in several schedules but in small packages is an unscheduled medicine. (a) the person is the occupier of premises; and (b) a vending machine is installed on the premises; and (c) the vending machine is used, or available for use, for the supply of an unscheduled medicine. (3) Subsection (2) does not apply if the vending machine was placed on the premises without the occupier’s consent. (4) Also, subsection (2) does not apply if— (a) the unscheduled medicine is supplied in a manufacturer’s pack containing not more than 2 adult doses of the medicine; and (b) the medicine was packed in the manufacturer’s pack by the manufacturer of the medicine; and

Paints—offences Division 4.3.6 (c) the vending machine is presented and located in a way that makes unsupervised access by children unlikely.

70 Manufacture, supply and use of paints containing white lead (a) the person manufactures a paint containing basic lead carbonate (white lead); and (b) the paint is not manufactured as prescribed by regulation. (a) the person supplies a paint containing basic lead carbonate (white lead); and (b) the paint is not supplied as prescribed by regulation. (a) the person uses a paint containing basic lead carbonate (white lead); and (b) the paint is not used as prescribed by regulation.

71 Manufacture, supply and use of paints for certain purposes (1) A person commits an offence if the person manufactures, supplies or uses a first group paint as prescribed by regulation. Maximum penalty: 40 penalty units. (2) A person commits an offence if the person manufactures, supplies or uses a second group paint as prescribed by regulation. (3) A person commits an offence if the person manufactures, supplies or uses a paint or tinter as prescribed by regulation.

72 Manufacture, supply and use of paints for toys (a) the person manufactures, supplies or uses a paint for application to toys; and (b) the paint is not prescribed by regulation.

73 Manufacture, supply and use of paints containing pesticides (a) the person manufactures, supplies or uses a paint containing a pesticide; and

Paints—offences Division 4.3.6 (b) the pesticide is not prescribed by regulation.

Chapter 5 Offences relating to regulated therapeutic goods Chapter 5 Offences relating to regulated 74 Supplying regulated therapeutic goods (a) the person supplies a regulated therapeutic good to someone else; and (b) the person is not authorised to supply the good to the other Note 1 Supply includes sell or offer to sell (see s 24). Note 2 Regulated therapeutic good—see s 14. (2) Subsection (1) does not apply if the person supplies sterile injecting equipment to someone else for the purpose of preventing the spread of blood-borne disease. (a) the person supplies a regulated therapeutic good to themself; and (b) the person is not authorised to supply the good to themself. (4) A person does not commit an offence under the Criminal Code, section 45 (Complicity and common purpose) in relation to an offence committed by another person under subsection (3) of this section only because the person supplies sterile injecting equipment to the other person for the purpose of preventing the spread of blood- borne disease.

Offences relating to regulated therapeutic goods Chapter 5

75 Contravening authorisation conditions for regulated (a) the person is authorised to deal with a regulated therapeutic good; and (c) the person contravenes the condition.

76 Pretending to be authorised to deal with regulated A person commits an offence if the person pretends to be authorised to deal with a regulated therapeutic good.

77 Falsely representing thing is regulated (1) A person (the supplier) commits an offence if— (a) the supplier supplies a thing as a particular regulated therapeutic good (the purported therapeutic good); and (b) the supplier knows that the thing is not the purported therapeutic

Chapter 5 Offences relating to regulated therapeutic goods (2) A person (the supplier) commits an offence if— (a) the supplier supplies a thing as a particular regulated therapeutic good (the purported therapeutic good); and (b) the supplier is reckless about whether the thing is the purported therapeutic good.

Chapter 6 Licences for regulated substances and regulated

78 Meaning of licence etc—ch 6 licence means a licence that authorises the licence-holder to deal with a regulated substance or regulated therapeutic good. (2) A regulation may prescribe the licences that may be issued under this Act. (3) To remove any doubt, the chief health officer may issue a licence to a person to deal with a regulated substance or regulated therapeutic good even if the licence is not prescribed by regulation for subsection (2).

79 Meaning of close associate—ch 6 close associate—a person is a close associate of someone (the related person) if— (a) the person holds or will hold an executive position (however described) in the related person’s business; or (b) the chief health officer is satisfied that the person is or will be able to exercise a significant influence in relation to the conduct of the related person’s business because the person holds or will hold a financial interest, or is entitled to exercise a relevant power, in the business. Note Business—see the dictionary.

executive position—a position (however described) in the related person’s business is an executive position if the holder of the position is concerned with, or takes part in, the management of the business. exercise a power includes exercise the power on behalf of someone else. financial interest, in a business, means— (a) a share in the capital of the business; or (b) an entitlement to receive income derived from the business, however the entitlement arises. hold a position includes hold the position on behalf of someone else. power means a power exercisable— (a) by voting or otherwise; and (b) alone or with others. relevant power, in a business, means a power— (a) to take part in a directorial, managerial or executive decision for the business; or (b) to elect or appoint a person as an executive officer in the business.

80 Meaning of influential person for corporation—ch 6 influential person, for a corporation, means any of the following: (a) an executive officer of the corporation; (b) a person who may exercise a relevant power in relation to the corporation; (c) a related corporation;

(d) an executive officer of a related corporation. related corporation means a related body corporate under the Corporations Act. relevant power, for a corporation, means a power— (a) to take part in a directorial, managerial or executive decision for the corporation; or (b) to elect or appoint a person as an executive officer in the corporation; or (c) to exercise a significant influence in relation to the conduct of the corporation.

81 Suitability of individuals for licences (1) In deciding whether an individual is a suitable person to hold a licence, the chief health officer must have regard to the following: (a) the knowledge, experience and training of the individual in relation to the regulated substances or regulated therapeutic goods to which the licence relates; (b) the dealings with regulated substances or regulated therapeutic goods to which the licence relates; (c) whether the individual or a close associate of the individual, or a corporation of which the individual was at the relevant time an executive officer, has— (i) supplied information or a document in relation to this Act that is false or misleading in a material particular; or (ii) contravened this Act or a corresponding law, whether or not the individual, associate or corporation has been convicted or found guilty of an offence for the contravention; or

(iii) failed to comply with a condition of a licence under this Act or a licence (however described) under a corresponding law, whether or not the individual, associate or corporation has been convicted or found guilty of an offence for the failure; (d) anything prescribed by regulation. Note A reference to an Act includes a reference to statutory instruments made (2) However, an individual is not a suitable person to hold a licence if— (a) the individual, a close associate of the individual, or a corporation of which the individual was at the relevant time an executive officer, has been convicted or found guilty of any of the following in the 5-year period before the day the application for the licence is made: (i) an offence against this Act; (ii) an offence in Australia or elsewhere in relation to a regulated substance or regulated therapeutic good; or (b) the individual, or a close associate of the individual, is, or was at any time in the 5-year period before the day the application for the licence is made, bankrupt or personally insolvent; or Note Bankrupt or personally insolvent—see the Legislation Act, dictionary, pt 1. (c) at any time in the 5-year period before the day the application for the licence is made, the individual, or a close associate of the individual, was involved in the management of a corporation when— (i) the corporation became the subject of a winding-up order; or (ii) an administrator was appointed for the corporation; or

(d) a circumstance prescribed by regulation applies in relation to the individual or a close associate of the individual. (3) Despite subsection (2), the chief health officer may decide that an individual is a suitable person to hold a licence if satisfied that— (a) the individual’s dealings with regulated substances or regulated therapeutic goods authorised, or to be authorised, by the licence would not be inconsistent with the objects of this Act if the chief health officer 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.

82 Suitability of corporations for licences (1) For this Act, a corporation is a suitable person for a licence if— (a) each influential person of the corporation is a suitable person to hold a licence; and (b) the corporation 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 licence is made; and (c) an administrator has not been appointed for the corporation in the 5-year period before the day the application for the licence is made. (2) However, if a corporation is not a suitable person for a licence under subsection (1), the chief health officer may decide that the corporation is a suitable person to hold a licence if satisfied that— (a) the corporation’s dealings with regulated substances or regulated therapeutic goods authorised, or to be authorised, by the licence would not be inconsistent with the objects of this Act if the chief health officer decided that the corporation is a suitable person; and

(b) it is otherwise in the public interest that the corporation be treated as a suitable person.

83 Power to ask for information etc from applicants and others application means— (a) an application for a licence; or (b) an application to amend a licence. designated person, in relation to an applicant or licence means— (a) the applicant or licence-holder; or (b) a close associate of, or influential person for, the applicant or licence-holder. (2) The chief health officer may, in writing, ask a designated person in relation to an application or licence to do 1 or more of the following: (a) give the chief health officer stated information relevant to the application or licence; (b) produce for the chief health officer’s inspection a stated document relevant to the application or licence; (c) allow the chief health officer to examine, copy or take extracts from a stated document relevant to the application or licence (including a document produced for the chief health officer’s inspection under paragraph (b)); (d) verify, by a statement or otherwise, information given or a document produced to the chief health officer; (e) authorise a stated person to do anything mentioned in paragraphs (a) to (d);

(f) give the chief health officer the authorities and consents that the chief health officer asks for to allow the chief health officer to obtain from other people information (including financial and other confidential information) that is— (i) about the designated person; and (ii) relevant to— (A) the consideration of the application; or (B) a consideration of whether the licence-holder continues to be a suitable person for a licence. Examples—par (a) 1 The notice may ask the designated person to give information by preparing a document in a stated way or by completing a document provided by the chief health officer.

2 The notice may ask the designated person to give the chief health officer information about a close associate because of a change of the kind to which section 93 (Licensee to keep chief health officer informed) applies. Example—par (b) a statement supplied by a police officer about the applicant’s criminal history (if any) Example—par (c) The notice may ask the applicant to authorise the applicant’s accountant, or a former close associate, to give the chief health officer stated information or documents about the applicant. (3) A request under subsection (2) must state a reasonable time within which the request must be complied with.

84 Applications for licences (1) A person may apply to the chief health officer for a licence. (2) The applicant must give the chief health officer a written statement (a change statement) if, before the application is decided, a change happens in relation to— (a) something mentioned in the application; or (b) a document, or something mentioned in a document, that accompanied the application. (3) A change statement must— (a) set out the details of the change; and (b) ask the chief health officer to amend the application to include the change; and (c) be signed by the applicant.

85 Decision on applications for licences (1) On application under section 84, the chief health officer must issue the licence to the applicant if satisfied that— (a) no restriction on the issue of the licence prescribed by regulation applies in relation to the applicant; and (b) the applicant is a suitable person to hold the licence; and (c) the applicant can comply with this Act in relation to the regulated substances or regulated therapeutic goods to which the application relates. (2) The chief health officer must refuse to issue the licence if not satisfied about the matters mentioned in subsection (1).

(3) However, the chief health officer need not decide the application if the chief health officer has asked for something under section 83 and the request has not been complied with.

86 Term of licences (1) A licence is issued for the period stated in the licence. (2) A licence must not be issued for longer than 3 years, or any shorter period prescribed by regulation.

87 Licences not transferable A licence is not transferable.

88 Form of licences (1) A licence must be in writing and include the following information: (a) what licence it is or the dealings with regulated substances or regulated therapeutic goods authorised by the licence; (b) the regulated substances or regulated therapeutic goods to which the licence relates; (c) the full name of the licence-holder; (d) the licence-holder’s ABN (if any); (e) if the licence-holder is a corporation—the corporation’s ACN; (f) if applicable, the location of the premises where the licence-holder is authorised to deal with a regulated substance or regulated therapeutic good under the licence; (g) if applicable, the name of each individual who is to supervise the dealings authorised under the licence; (h) any conditions included in the licence by the chief health officer; Note See s 90 to s 92 for conditions included in a licence by the chief health officer.

(i) a unique identifying number; (j) when the term of the licence ends; (k) any other information prescribed by regulation. (2) For this Act, the conditions mentioned in subsection (1) (h) may be included in a separate document and, if they are, the separate document forms part of the licence.

89 Statutory licence conditions A licence is subject to the following conditions: (a) the licence-holder must comply with any written request by the chief health officer under section 83 (Power to ask for information etc from applicants and others) in relation to the amendment of the licence; (b) if section 93 (Licensee to keep chief health officer informed) applies in relation to the licence-holder, the licence-holder must comply with the section; (c) a condition prescribed by regulation.

90 Other licence conditions (1) A licence is subject to any condition the chief health officer includes in the licence when giving the licence or at any other time. (2) For subsection (1), the chief health officer may include a condition in a licence to ensure that regulated substances and regulated therapeutic goods are properly dealt with under the licence, including, for example— (a) a condition about— (i) the supervision of the dealings; and

(ii) the security of regulated substances and regulated therapeutic goods and of premises where regulated substances and regulated therapeutic goods are stored; and (iii) the keeping of records about the dealings; and (b) for a regulated substance—a condition recommended by the medicines and poisons standard for dealing with the regulated

91 Amending licence on chief health officer’s initiative (1) The chief health officer may, by written notice (an amendment notice) given to a licence-holder, amend the licence to change a licence condition. (2) However, the chief health officer may amend the licence to change a licence condition only if— (a) the chief health officer has given the licence-holder written notice (a proposal notice) of the proposed amendment; and (b) the notice states that written comments on the proposal may be made to the chief health officer before the end of a stated period of at least 14 days after the day the proposal notice is given to the licence-holder; and (c) after the end of the stated period, the chief health officer has considered any comments made in accordance with the notice. (3) The amendment takes effect on the day the amendment notice is given to the licence-holder or any later day stated in the notice. change, for a licence condition, means— (a) amend an existing licence condition; or (b) impose a new licence condition; or (c) remove an existing licence condition.

condition does not include a condition mentioned in section 89 (Statutory licence conditions).

92 Amending licence on application by licence-holder (1) A licence-holder may apply to the chief health officer to amend the licence (including by changing a licence condition). (2) In deciding whether to amend the licence, the chief health officer may consider anything that may be considered under section 85 (Decision on applications for licences) in relation to an application for a licence. (3) If the chief health officer receives an application under subsection (1), the chief health officer must— (a) amend the licence in accordance with the application; or (b) amend the licence in terms different to the application; or (c) refuse to amend the licence. (4) However, the chief health officer need not decide the application if the chief health officer has asked for something under section 83 (Power to ask for information etc from applicants and others) and the request has not been complied with. change, for a licence condition—see section 91 (4). condition—see section 91 (4).

93 Licensee to keep chief health officer informed (1) This section applies if a licence-holder believes that there will be a change (the anticipated change) to anything stated in— (a) the licence; or (b) the application for the licence; or

(c) an application to amend the licence. Note Failure to comply with this section contravenes a condition of the licence (see s 89 (b)). (2) The licence-holder must— (a) give the chief health officer written notice of the anticipated change not later than 7 days before the day the change is expected to happen; and (b) if the change affects the information shown on the licence— apply under section 92 to amend the licence to take account of the change. Examples of changes 1 a change of the person who, under the licence that authorises the supply by wholesale of a controlled medicine, must supervise the supply of the medicine 2 a change in a close associate of, or influential person for, the licence-holder 3 a structural change in premises relevant to dealing with a regulated substance

94 Returning licences for amendment (1) A licence-holder commits an offence if— (a) the licence-holder’s licence is amended under section 91 (Amending licence on chief health officer’s initiative) or section 92 (Amending licence on application by licence-holder); and (b) the licence-holder fails to return the licence to the chief health officer as soon as practicable (but not later than 7 days) after the day the licence-holder is told about the chief health officer’s action or decision. Maximum penalty: 20 penalty units.

95 Replacing licences (1) The chief health officer may issue a replacement licence to a licence-holder if satisfied that the licence-holder’s original licence has been lost, stolen or destroyed. (2) For subsection (1), the chief health officer may require the licence-holder to give the chief health officer a statement verifying that the original licence has been lost, stolen or destroyed.

Licences—other provisions Part 6.3 Part 6.3 Licences—other provisions

96 Contravening licence conditions (a) the person is a licence-holder; and (b) the licence is subject to a condition; and (c) the person is reckless about whether an act or omission by the person contravenes the condition. (2) A licence-holder commits an offence if the licence-holder contravenes a condition of the licence.

97 Surrendering licences (1) A licence-holder may surrender the licence by giving written notice of the surrender to the chief health officer. (2) The licence-holder must, with the notice— (a) return the licence to the chief health officer; or (b) if the licence has been lost, stolen or destroyed—give the chief health officer a statement verifying that the licence has been lost, stolen or destroyed.

97A Meaning of monitored medicine monitored medicine means— (a) a controlled medicine; or (b) a medicine declared by the Minister to be a monitored medicine. (2) For the definition of monitored medicine, paragraph (b), the Minister may declare a medicine to be a monitored medicine if satisfied that the declaration is consistent with the purposes of the monitored medicines database. (3) A declaration under this section is a disallowable instrument.

97B Definitions—ch 6A another jurisdiction— (a) means the Commonwealth or a State; and (b) includes an entity established under a law of the Commonwealth or a State. Note State includes the Northern Territory (see Legislation Act, dict, pt 1). approved data source entity means an entity engaged by another jurisdiction to collect, access, store or otherwise deal with information about monitored medicines. monitored medicines database—see section 97D.

relevant health practitioner means a health practitioner authorised by regulation to prescribe or supply a monitored medicine. required information, about the supply of a monitored medicine— see section 31 (4).

97C Monitored medicines database—purposes (1) The main purpose of the monitored medicines database is to promote and protect public health and safety by ensuring that information is available to— (a) monitor and evaluate the supply of monitored medicines to a person; and (b) support the exercise of the chief health officer’s functions. (2) A regulation may prescribe additional purposes for the monitored medicines database.

97D Monitored medicines database—scope (1) The chief health officer may keep a database (the monitored medicines database) to record information relating to monitored medicines. (2) The monitored medicines database may be kept in any form, including electronically, that the chief health officer decides. (3) The chief health officer may— (a) correct an error or omission in the monitored medicines (b) change information included in the database to keep the database accurate and up-to-date. (4) The monitored medicines database may include the following: (a) required information about the supply of a monitored medicine under a supply authority;

(b) information about the approval to prescribe a monitored medicine; (c) information from another jurisdiction in relation to the supply or prescription of a monitored medicine in the other jurisdiction; (d) information in relation to a monitored medicine from an approved data source entity; (e) any other information prescribed by regulation.

97E Monitored medicines database—chief health officer functions The chief health officer has the following functions in relation to the monitored medicines database: (a) to collect and store required information about monitored medicines; (b) to enter into an arrangement with another jurisdiction or an approved data source entity to— (i) collect and store information for the database; and (ii) allow access to information on the database; and (iii) allow the use and disclosure of information on the database; (c) to access and use the database to— (i) monitor, promote and protect public health and safety; and (ii) facilitate research into the provision of healthcare; and (iii) administer, develop and operate the database; and (iv) ensure compliance with the Act; (d) to allow access to, and the use and disclosure of, information on the database by a person mentioned in section 97F or section 97G (Monitored medicines database—access authority);

(e) any other function under this Act or another territory law. Note A provision of a law that gives an entity (including a person) a function also gives the entity powers necessary and convenient to exercise the function (see Legislation Act, s 196 and dict, pt 1, def entity).

97F Monitored medicines database—access and use by relevant health practitioners (1) A relevant health practitioner may access and use the monitored medicines database for 1 or more of the following purposes: (a) to inform decisions in relation to the prescription or supply of a monitored medicine to a person under the relevant health practitioner’s care; (b) to inform decisions in relation to the treatment or care of a person under the relevant health practitioner’s care; (c) to disclose information about a person under the relevant health practitioner’s care to that person; (d) to disclose information about a person under the relevant health practitioner’s care to another health practitioner involved in the person’s treatment or care; (e) a purpose prescribed by regulation. (2) The chief health officer must make the monitored medicines database available to a relevant health practitioner at no cost.

97G Monitored medicines database—access authority (1) A person, other than a relevant health practitioner, may apply to the chief health officer for authorisation to access and use the monitored medicines database (an access authority).

(2) The chief health officer may issue the access authority only if satisfied that giving the access authority to the person is— (a) consistent with a purpose of the monitored medicines database; and (b) otherwise in the public interest. (3) An access authority must— (a) be in writing; and (b) include the following information: (i) the name of the person to whom the authority is issued; (ii) the purpose for which the authority is issued; (iii) any conditions applying to the authority; (iv) the expiry date of the authority.

97H Monitored medicines database—offences (b) the access is not authorised under this chapter. Maximum penalty: 30 penalty units. (b) the person uses the accessed information; and (c) the use is not authorised under this chapter.

(b) the person discloses the accessed information to someone else; and (c) the disclosure is not authorised under this chapter. (4) Strict liability applies to subsections (1) (a), (2) (a) and (3) (a). disclose, in relation to information accessed from the monitored medicines database, includes— (a) communicate the information; or (b) publish the information. use, in relation to information accessed from the monitored medicines database, includes make a record of the information.

98 Definitions—pt 7.1 connected—a thing is connected with an offence if— (a) the offence has been committed in relation to it; or (b) it will provide evidence of the commission of the offence; or (c) it was used, is being used, or is intended to be used, to commit the offence. occupier, of premises, includes— (a) a person believed on reasonable grounds to be an occupier of the premises; and (b) a person apparently in charge of the premises. offence includes an offence that there are reasonable grounds for believing has been, is being, or will be, committed.

99 Meaning of medicines and poisons inspector—Act medicines and poisons inspector means— (a) a police officer; or (b) a person appointed under section 100.

Medicines and poisons inspectors Division 7.1.2

Division 7.1.2 Medicines and poisons inspectors

100 Appointment of medicines and poisons inspectors The chief health officer may appoint a public servant to be a medicines and poisons inspector for this Act. Note 1 For the making of appointments (including acting appointments), see the Legislation Act, pt 19.3. Note 2 In particular, a person may be appointed for a particular provision of a law (see Legislation Act, s 7 (3)) and an appointment may be made by naming a person or nominating the occupant of a position (see Legislation Act, s 207).

101 Identity cards (1) The chief health officer must give a medicines and poisons inspector (other than a police officer) an identity card stating the person’s name and that the person is a medicines and poisons inspector. (2) The identity card must show— (a) a recent photograph of the person; and (b) the card’s date of issue and expiry; and (c) anything else prescribed by regulation. (a) the person stops being a medicines and poisons inspector; and (b) the person does not return the person’s identity card to the chief health officer as soon as practicable (but not later than 7 days) after the day the person stops being a medicines and poisons inspector. Maximum penalty: 1 penalty unit. (4) An offence against this section is a strict liability offence.

Division 7.1.3 Powers of medicines and poisons inspectors

102 Power to enter premises (1) For this Act, a medicines and poisons inspector may— (a) at any reasonable time, enter premises that the public is entitled to use or that are open to the public (whether or not on payment); or (b) at any time, enter premises with the occupier’s consent; or (c) enter premises in accordance with a search warrant; or (d) at any time, enter premises if the inspector believes on reasonable grounds that the circumstances are so serious and urgent that immediate entry to the premises without the authority of a search warrant is necessary. (2) However, subsection (1) (a) does not authorise entry into a part of premises that is being used only for residential purposes. (3) A medicines and poisons inspector may, without the consent of the occupier of premises, enter land around the premises to ask for consent to enter the premises. (4) To remove any doubt, a medicines and poisons inspector may enter premises under subsection (1) without payment of an entry fee or other charge. at any reasonable time includes at any time when the public is entitled to use the premises, or when the premises are open to or used by the public (whether or not on payment).

103 Production of identity card A medicines and poisons inspector must not remain at premises entered under this part if the inspector does not produce their identity card when asked by the occupier.

104 Consent to entry (1) When seeking the consent of an occupier of premises to enter the premises under section 102 (1) (b), a medicines and poisons inspector must— (a) produce their identity card; and (b) tell the occupier— (i) the purpose of the entry; and (ii) that anything found and seized under this part may be used in evidence in court; and (iii) that consent may be refused. (2) If the occupier consents, the medicines and poisons inspector must ask the occupier to sign a written acknowledgment (an acknowledgment of consent)— (a) that the occupier was told— (i) the purpose of the entry; and (ii) that anything found and seized under this part may be used in evidence in court; and (iii) that consent may be refused; and (b) that the occupier consented to the entry; and (c) stating the time and date when consent was given. (3) If the occupier signs an acknowledgment of consent, the medicines and poisons inspector must immediately give a copy to the occupier.

(4) A court must find that the occupier did not consent to entry to the premises by the medicines and poisons inspector under this division if— (a) the question arises in a proceeding in the court whether the occupier consented to the entry; and (b) an acknowledgment of consent is not produced in evidence; and (c) it is not proved that the occupier consented to the entry.

105 General powers on entry to premises (1) A medicines and poisons inspector who enters premises under this part may, for this Act, do 1 or more of the following in relation to the premises or anything on the premises: (a) inspect or examine; (b) examine and copy, or take extracts from, documents relating to a regulated substance or regulated therapeutic good; (c) examine and copy, or take extracts from, any packaging, labelling or advertising material; (d) take measurements or conduct tests; (e) take samples; (f) subject to part 7.2 (Taking and analysis of samples of substances), take for analysis samples of anything else (including any substance) at the premises; (g) open (or require to be opened) any container or package that the inspector believes on reasonable grounds contains a regulated substance or regulated therapeutic good; (h) take photographs, films, or audio, video or other recordings;

(i) require the occupier, or anyone at the premises, to give information, answer questions, or produce documents or anything else, reasonably needed to exercise the inspector’s functions under this Act. Note The Legislation Act, s 170 and s 171 deal with the application of the privilege against self-incrimination and client legal privilege. (2) A person must take all reasonable steps to comply with a requirement made of the person under subsection (1) (g) or (i).

106 Power to seize things (1) A medicines and poisons inspector who enters premises under this part with the occupier’s consent may seize anything at the premises if— (a) the inspector is satisfied on reasonable grounds that the thing is connected with an offence against this Act; and (b) seizure of the thing is consistent with the purpose of the entry told to the occupier when seeking the occupier’s consent. (2) A medicines and poisons inspector who enters premises under a warrant under this part may seize anything at the premises that the inspector is authorised to seize under the warrant. (3) A medicines and poisons inspector who enters premises under this part (whether with the occupier’s consent, under a warrant or otherwise) may seize anything at the premises if satisfied on reasonable grounds that— (a) the thing is connected with an offence against this Act; and (b) the seizure is necessary to prevent the thing from being— (i) concealed, lost or destroyed; or (ii) used to commit, continue or repeat the offence.

(4) Also, a medicines and poisons inspector who enters premises under this part (whether with the occupier’s consent or otherwise) may seize anything at the premises if satisfied on reasonable grounds that the thing— (b) may cause damage to property or the environment. (5) The powers of a medicines and poisons inspector under subsections (3) and (4) are additional to any powers of the inspector under subsection (1) or any other territory law. (6) Having seized a thing, a medicines and poisons inspector may— (a) remove the thing from the premises where it was seized (the place of seizure) to another place; or (b) leave the thing at the place of seizure but restrict access to it. (7) A person commits an offence if— (a) the person interferes with a seized thing, or anything containing a seized thing, to which access has been restricted under subsection (6); and (b) the person does not have a medicines and poisons inspector’s approval to interfere with the thing. (8) An offence against this section is a strict liability offence.

107 Power to destroy unsafe things (1) This section applies to anything inspected or seized under this part by a medicines and poisons inspector if the inspector is satisfied on reasonable grounds that the thing— (b) is likely to cause damage to property or the environment.

(2) The medicines and poisons inspector may direct an occupier of the premises where the thing is to destroy or otherwise dispose of the thing. (3) The direction may state 1 or more of the following: (a) how the thing must be destroyed or otherwise disposed of; (b) how the thing must be kept until it is destroyed or otherwise disposed of; (c) the period within which the thing must be destroyed or otherwise disposed of. (4) A person given a direction under subsection (2) commits an offence if the person contravenes a direction given to the person under subsection (2). Maximum penalty: 100 penalty units. (5) Alternatively, if the thing has been seized under this part, the medicines and poisons inspector may destroy or otherwise dispose of the thing. (6) Costs incurred by the Territory in relation to the disposal of a thing under subsection (5) are a debt owing to the Territory by, and are recoverable together and separately from, the following people: (a) the person who owned the thing; (b) each person in charge of the premises where the thing was. (7) An offence against this section is a strict liability offence.

108 Power to require name and address (1) A medicines and poisons inspector may require a person to state the person’s name and home address if the inspector believes on reasonable grounds that the person is committing or has just committed an offence against this Act. (2) The medicines and poisons inspector must tell the person the reason for the requirement and, as soon as practicable, record the reason. (3) The person may ask the medicines and poisons inspector to produce the inspector’s identity card for inspection by the person. (4) A person must comply with a requirement under subsection (1) if the medicines and poisons inspector— (a) tells the person the reason for the requirement; and (b) complies with any request made by the person under subsection (3). Maximum penalty: 10 penalty units.

109 Warrants generally (1) A medicines and poisons inspector may apply to a magistrate for a warrant to enter premises. (2) The application must be sworn and state the grounds on which the warrant is sought. (3) The magistrate may refuse to consider the application until the medicines and poisons inspector gives the magistrate all the information the magistrate requires about the application in the way the magistrate requires.

(4) The magistrate may issue a warrant only if satisfied there are reasonable grounds for suspecting— (a) there is a particular thing or activity connected with an offence against this Act; and (b) the thing or activity is, or is being engaged in, at the premises, or may be, or may be engaged in, at the premises within the next 14 days. Note At premises includes in or on the premises (see dict). (5) The warrant must state— (a) that a medicines and poisons inspector may, with any necessary assistance and force, enter the premises and exercise the inspector’s powers under this part; and (b) the offence for which the warrant is issued; and (c) the things that may be seized under the warrant; and (d) the hours when the premises may be entered; and (e) the date, within 14 days after the day of the warrant’s issue, that the warrant ends. (6) In this section: connected—an activity is connected with an offence if— (a) the offence has been committed by engaging or not engaging in it; or (b) it will provide evidence of the commission of the offence.

110 Warrants—application made other than in person (1) A medicines and poisons inspector may apply for a warrant by phone, fax, radio or other form of communication if the inspector considers it necessary because of— (a) urgent circumstances; or (b) other special circumstances. (2) Before applying for the warrant, the medicines and poisons inspector must prepare an application stating the grounds on which the warrant is sought. (3) The medicines and poisons inspector may apply for the warrant before the application is sworn. (4) After issuing the warrant, the magistrate must immediately provide a written copy to the medicines and poisons inspector if it is practicable to do so. (5) If it is not practicable to provide a written copy to the medicines and poisons inspector— (a) the magistrate must— (i) tell the inspector what the terms of the warrant are; and (ii) tell the inspector the date and time the warrant was issued; and (b) the inspector must complete a form of warrant (the warrant form) and write on it— (i) the magistrate’s name; and (ii) the date and time the magistrate issued the warrant; and (iii) the warrant’s terms. (6) The written copy of the warrant, or the warrant form properly completed by the medicines and poisons inspector, authorises the entry and exercise of the inspector’s powers under this part.

(7) The medicines and poisons inspector must, at the first reasonable opportunity, send to the magistrate— (a) the sworn application; and (b) if the inspector completed a warrant form—the completed warrant form. (8) On receiving the documents, the magistrate must attach them to the warrant. (9) A court must find that a power exercised by a medicines and poisons inspector was not authorised by a warrant under this section if— (a) the question arises in a proceeding before the court whether the exercise of power was authorised by a warrant; and (b) the warrant is not produced in evidence; and (c) it is not proved that the exercise of power was authorised by a warrant under this section.

111 Search warrants—announcement before entry (1) A medicines and poisons inspector must, before anyone enters premises under a search warrant— (a) announce that the inspector is authorised to enter the premises; and (b) give anyone at the premises an opportunity to allow entry to the premises; and (c) if an occupier of the premises, or someone else who apparently represents the occupier, is present at the premises—identify themself to the person.

(2) The medicines and poisons inspector is not required to comply with subsection (1) if the inspector believes on reasonable grounds that immediate entry to the premises is required to ensure— (a) the safety of anyone (including the inspector or any person assisting); or (b) that the effective execution of the warrant is not frustrated.

112 Details of search warrant to be given to occupier etc If an occupier of premises, or someone else who apparently represents the occupier, is present at the premises while a search warrant is being executed, the medicines and poisons inspector or a person assisting must make available to the person— (a) a copy of the warrant; and (b) a document setting out the rights and obligations of the person.

113 Occupier entitled to be present during search etc (1) If an occupier of premises, or someone else who apparently represents the occupier, is present at the premises while a search warrant is being executed, the occupier or the other person is entitled to observe the search being conducted. (2) However, the person is not entitled to observe the search if— (a) to do so would impede the search; or (b) the person is under arrest, and allowing the person to observe the search being conducted would interfere with the objectives of the search. (3) This section does not prevent 2 or more areas of the premises being searched at the same time.

114 Moving things to another place for examination or processing (1) A thing found at premises entered under a search warrant may be moved to another place for examination or processing to decide whether it may be seized under the warrant if— (a) both of the following apply: (i) there are reasonable grounds for believing that the thing is or contains something to which the warrant relates; (ii) it is significantly more practicable to do so having regard to the timeliness and cost of examining or processing the thing at another place and the availability of expert assistance; or (b) the occupier of the premises agrees in writing. (2) The thing may be moved to another place for examination or processing for not longer than 72 hours. (3) A medicines and poisons inspector may apply to a magistrate for an extension of time if the inspector believes on reasonable grounds that the thing cannot be examined or processed within 72 hours. (4) The medicines and poisons inspector must give notice of the application to the occupier of the premises, and the occupier is entitled to be heard on the application. (5) If a thing is moved to another place under this section, the medicines and poisons inspector must, if practicable— (a) tell the occupier of the premises the address of the place where, and time when, the examination or processing will be carried out; and (b) allow the occupier or the occupier’s representative to be present during the examination or processing.

(6) The provisions of this part relating to the issue of search warrants apply, with any necessary changes, to the giving of an extension under this section.

115 Use of electronic equipment at premises (1) A medicines and poisons inspector or a person assisting may operate electronic equipment at premises entered under a search warrant to access data (including data not held at the premises) if the inspector or person believes on reasonable grounds that— (a) the data might be something to which the warrant relates; and (b) the equipment can be operated without damaging the data. (2) If the medicines and poisons inspector or person assisting believes on reasonable grounds that any data accessed by operating the electronic equipment might be something to which the warrant relates, the inspector or person may— (a) copy the data to a data storage device brought to the premises; or (b) if the occupier of the premises agrees in writing—copy the data to a data storage device at the premises. (3) The medicines and poisons inspector or person assisting may take the device from the premises. (4) The medicines and poisons inspector or person assisting may do the following things if the inspector or person finds that anything (the material) to which the warrant relates is accessible using the equipment: (a) seize the equipment and any data storage device; (b) if the material can, by using facilities at the premises, be put in documentary form—operate the facilities to put the material in documentary form and seize the documents produced.

(5) A medicines and poisons inspector may seize equipment under subsection (4) (a) only if— (a) it is not practicable to copy the data as mentioned in subsection (2) or to put the material in documentary form as mentioned in subsection (4) (b); or (b) possession of the equipment by the occupier of the premises or someone else could be an offence.

116 Person with knowledge of computer to assist access etc (1) A medicines and poisons inspector may apply to a magistrate for an order requiring a stated person to provide any information or assistance that is reasonably necessary to allow the inspector or a person assisting to do 1 or more of the following: (a) access data held in or accessible from a computer that is at the premises; (b) copy the data to a data storage device; (c) convert the data into documentary form. (2) The magistrate may make an order if satisfied that— (a) there are reasonable grounds for suspecting that something to which the warrant relates is accessible from the computer; and (b) the stated person is— (i) reasonably suspected of possessing, or having under the person’s control, something to which the warrant relates; or (ii) the owner or lessee of the computer; or (iii) an employee or agent of the owner or lessee of the computer; and

(c) the stated person has knowledge of— (i) the computer or a computer network of which the computer forms a part; or (ii) measures applied to protect data held in or accessible from the computer. (3) A person commits an offence if the person contravenes an order under this section. (4) The provisions of this part relating to the issue of search warrants apply, with any necessary changes, to the making of an order under this section.

117 Securing electronic equipment (1) This section applies if the medicines and poisons inspector or a person assisting believes on reasonable grounds that— (a) something (the material) to which the warrant relates may be accessible by operating electronic equipment at the premises; and (b) expert assistance is required to operate the equipment; and (c) the material may be destroyed, altered or otherwise interfered with if the inspector or person does not take action. (2) The medicines and poisons inspector or person assisting may do whatever is necessary to secure the equipment, whether by locking it up, placing a guard or otherwise.

(3) The medicines and poisons inspector or a person assisting must give written notice to an occupier of the premises of— (a) the inspector’s or person’s intention to secure the equipment; and (b) the fact that the equipment may be secured for up to 24 hours. (4) The equipment may be secured until the earlier of the following events happens: (a) the end of the 24-hour period; (b) the equipment is operated by the expert. (5) If the medicines and poisons inspector or a person assisting believes on reasonable grounds that the expert assistance will not be available within the 24-hour period, the inspector or person may apply to a magistrate to extend the period. (6) The medicines and poisons inspector or a person assisting must tell an occupier of the premises of the intention to apply for an extension, and the occupier is entitled to be heard on the application. (7) The provisions of this part relating to the issue of search warrants apply, with any necessary changes, to the giving of an extension under this section.

118 Copies of seized things to be provided (a) an occupier of premises, or someone else who apparently represents the occupier, is present at the premises while a search warrant is executed; and (b) the medicines and poisons inspector seizes— (i) a document, film, computer file or something else that can be readily copied; or (ii) a data storage device containing information that can be readily copied. (2) The occupier or other person may ask the medicines and poisons inspector to give the person a copy of the thing or information. (3) The medicines and poisons inspector must give the person the copy as soon as practicable after the seizure. (4) However, the medicines and poisons inspector is not required to give the copy if— (a) the thing was seized under section 115 (Use of electronic equipment at premises); or (b) possession of the thing or information by an occupier of the premises or someone else would be an offence.

119 Receipt for things seized (1) As soon as practicable after a medicines and poisons inspector seizes a thing under this part, the inspector must give a receipt for it to the person from whom it was seized. (2) If, for any reason, it is not practicable to comply with subsection (1), the medicines and poisons inspector must leave the receipt, secured conspicuously, at the place of seizure under section 106 (Power to seize things). (3) A receipt under this section must include the following: (a) a description of the thing seized; (b) an explanation of why the thing was seized; (c) the medicines and poisons inspector’s name, and how to contact the inspector; (d) if the thing is moved from the premises where it is seized— where the thing is to be taken.

120 Access to things seized (1) A person who would, apart from the seizure, be entitled to inspect a thing seized under this part may— (a) inspect it; and (b) if it is a document—take extracts from it or make copies of it. (2) This section does not apply to— (a) a thing seized under section 106 (4) (which is about the seizure of a thing that poses a risk to the health or safety of people or of damage to property or the environment); or

(b) a thing or information if possession of it by the person otherwise entitled to inspect it would be an offence.

121 Return of things seized (1) A thing seized under this part must be returned to its owner, or reasonable compensation must be paid by the Territory to the owner for the loss of the thing, if— (a) an infringement notice for an offence relating to the thing is not served on the owner within 90 days after the day of seizure and a prosecution for an offence relating to the thing— (i) is not started within the 90-day period; or (ii) is started within the 90-day period but the court does not find the offence proved; or (b) an infringement notice for an offence relating to the thing is served on the owner within 90 days after the day of seizure, the infringement notice is withdrawn and a prosecution for an offence relating to the thing— (i) is not started within the 90-day period; or (ii) is started within the 90-day period but the court does not find the offence proved; or (c) an infringement notice for an offence relating to the thing is served on the owner and not withdrawn within 90 days after the day of seizure, liability for the offence is disputed in accordance with the Magistrates Court Act 1930, section 132 (Disputing liability for infringement notice offence) and an information— (i) is not laid in the Magistrates Court against the person for the offence within 60 days after the day notice is given under section 132 that liability is disputed; or

(ii) is laid in the Magistrates Court against the person for the offence within the 60-day period, but the Magistrates Court does not find the offence proved. (2) However, this section does not apply— (a) to a thing seized under section 106 (4) (which is about the seizure of things that pose a risk to the health or safety of people or of damage to property or the environment); or (b) to a thing if the chief health officer believes on reasonable grounds that the only practical use of the thing in relation to the premises where it was seized would be an offence against this Act or another territory law; or (c) to a thing if possession of it by its owner would be an offence. Note See also section 125 (Forfeiture of seized things).

122 Application for order disallowing seizure (1) A person claiming to be entitled to anything seized under this part may apply to the Magistrates Court within 10 days after the day of the seizure for an order disallowing the seizure. (2) However, this section does not apply to a thing seized under section 106 (4) (which is about the seizure of things that pose a risk to the health or safety of people or of damage to property or the environment). (3) The application may be heard only if the applicant has served a copy of the application on the chief health officer. (4) The chief health officer is entitled to appear as respondent at the hearing of the application.

123 Order for return of seized thing (1) This section applies if a person claiming to be entitled to anything seized under this part applies to the Magistrates Court under section 122 for an order disallowing the seizure. (2) The Magistrates Court must make an order disallowing the seizure if satisfied that— (a) the applicant would, apart from the seizure, be entitled to the return of the seized thing; and (b) the thing is not connected with an offence against this Act; and (c) possession of the thing by the person would not be an offence. (3) The Magistrates Court may also make an order disallowing the seizure if satisfied there are exceptional circumstances justifying the making of the order. (4) If the Magistrates Court makes an order disallowing the seizure, the court may make 1 or more of the following ancillary orders: (a) an order directing the chief health officer to return the thing to the applicant or someone else that appears to be entitled to it; (b) if the thing cannot be returned or has depreciated in value because of the seizure—an order directing the Territory to pay reasonable compensation; (c) an order about the payment of costs in relation to the application.

124 Adjournment pending hearing of other proceedings (1) This section applies to the hearing of an application under section 122 (Application for order disallowing seizure). (2) If it appears to the Magistrates Court that the seized thing is required to be produced in evidence in a pending proceeding in relation to an offence against a territory law, the court may, on the application of the chief health officer or its own initiative, adjourn the hearing until the end of the pending proceeding.

125 Forfeiture of seized things (a) anything seized under this part has not been returned under section 121 (Return of things seized); and (b) an application for disallowance of the seizure under section 122 (Application for order disallowing seizure)— (i) has not been made within 10 days after the day of seizure; or (ii) has been made within the 10-day period, but the application has been refused or has been withdrawn before a decision in relation to the application had been made. (2) If this section applies to the seized thing— (a) it is forfeited to the Territory; and (b) it may be sold, destroyed or otherwise disposed of as the chief health officer directs.

126 Return of forfeited things (1) This section applies to something forfeited under section 125 that has not been disposed of in a way that would prevent its return. (2) If the chief health officer becomes satisfied that there has been no offence against this Act with which the thing is connected, the chief health officer must, as soon as practicable, return the thing to the person from whom it was seized or someone else who appears to the chief health officer to be entitled to it. (3) On its return, any proprietary and other interests in the thing that existed immediately before its forfeiture are restored.

127 Cost of disposal of forfeited things (a) a person is convicted, or found guilty, of an offence against this Act in relation to something forfeited to the Territory under this part; and (b) the thing is connected with an offence against this Act; and (c) the person was the owner of the thing immediately before its forfeiture. Note Found guilty—see the Legislation Act, dict, pt 1. (2) If this section applies, costs incurred by or on behalf of the Territory in relation to the lawful disposal of the thing (including storage costs) are a debt owing to the Territory by the person.

Medicines and poisons inspectors—other provisions Division 7.1.6 Division 7.1.6 Medicines and poisons inspectors— other provisions

128 Disposal etc of things obtained otherwise than under pt 7.1 (1) This section applies if the chief health officer comes into possession of a regulated substance or regulated therapeutic good otherwise than under this part. (2) The chief health officer may dispose of the regulated substance or regulated therapeutic good as prescribed by regulation.

129 Damage etc to be minimised (1) In the exercise, or purported exercise, of a function under this part, a medicines and poisons inspector must take all reasonable steps to ensure that the inspector, and any person assisting the inspector, causes as little inconvenience, detriment and damage as practicable. (2) If a medicines and poisons inspector, or a person assisting a medicines and poisons inspector, damages anything in the exercise or purported exercise of a function under this part, the inspector must give written notice of the particulars of the damage to the person the inspector believes on reasonable grounds is the owner of the thing. (3) If the damage happens at premises entered under this part in the absence of the occupier, the notice may be given by leaving it, secured conspicuously, at the premises.

Division 7.1.6 Medicines and poisons inspectors—other provisions

130 Compensation for exercise of enforcement powers (1) A person may claim compensation from the Territory if the person suffers loss or expense because of the exercise, or purported exercise, of a function under this part by a medicines and poisons inspector or a person assisting the inspector. (2) Compensation may be claimed and ordered in a proceeding for— (a) compensation brought in a court of competent jurisdiction; or (b) an offence against this Act brought against the person making the claim for compensation. (3) A court may order the payment of reasonable compensation for the loss or expense only if satisfied it is just to make the order in the circumstances of the particular case. (4) A regulation may prescribe matters that may, must or must not be taken into account by the court in considering whether it is just to make the order. (5) To remove any doubt, this section does not authorise a court to order the payment of compensation for regulated substances or regulated therapeutic goods seized by a medicines and poisons inspector if the substance or good was recalled under the Therapeutic Goods Act 1989 (Cwlth).

Taking and analysis of samples of substances Part 7.2

Part 7.2 Taking and analysis of samples of substances

131 Inspector may buy samples without complying with pt 7.2 This part does not stop a medicines and poisons inspector from buying a sample of a substance for analysis for the routine monitoring of compliance with this Act without complying with the requirements of this part. Note For the admissibility of the analysis of a sample of a substance taken by a medicines and poisons inspector, see s 181.

132 Person in charge etc to be told sample to be analysed (1) This section applies if a medicines and poisons inspector proposes to take, or takes, a sample of a substance for analysis from premises where a regulated substance is dealt with. (2) Before or as soon as practicable after taking the sample, the medicines and poisons inspector must tell a person in charge of the premises of the inspector’s intention to have the sample analysed. (3) If a person in charge is not present or readily available, the medicines and poisons inspector must instead tell the person from whom the sample was obtained of the inspector’s intention to have the sample analysed.

Part 7.2 Taking and analysis of samples of substances

133 Payment for samples (1) This section applies if a medicines and poisons inspector takes a sample of a substance for analysis from premises where a regulated substance is dealt with. (2) The medicines and poisons inspector must pay, or offer to pay, the person from whom the sample is taken— (a) the amount (if any) prescribed by regulation as the amount payable for the sample; or (b) if no amount is prescribed—the current market value of the sample.

134 Samples from packaged substances If a package of a substance contains 2 or more smaller packages of the same substance, the medicines and poisons inspector may take 1 of the smaller packages for analysis.

135 Procedures for dividing samples (1) This section— (a) applies to a sample of a substance being taken by a medicines and poisons inspector for analysis; and (b) is subject to section 136. (2) The medicines and poisons inspector must— (a) divide the sample into 3 parts, and mark and either seal or fasten each part; and (b) leave 1 part with the person told under section 132 (Person in charge etc to be told sample to be analysed) of the inspector’s intention to have the sample analysed; and (c) keep 1 part for analysis; and (d) keep 1 part for future comparison with the other parts.

Taking and analysis of samples of substances Part 7.2 (3) If a sample of a substance taken by a medicines and poisons inspector is in the form of separate or severable objects, the inspector— (a) may take a number of the objects; and (b) if the inspector takes a number of the objects, must— (i) divide them into 3 parts each consisting of 1 or more of the objects, or of the severable parts of the objects, and mark and either seal or fasten each part; and (ii) deal with the sample under subsection (2) (b) to (d).

136 Exception to usual procedures for dividing samples (1) This section applies to a sample of a substance being taken by a medicines and poisons inspector for analysis if dividing the substance into 3 parts would, in the inspector’s opinion— (a) so affect or impair the composition or quality of the sample as to make the parts unsuitable for accurate analysis; or (b) result in the parts being too small for accurate analysis; or (c) otherwise make the sample unsuitable for analysis (including a method of analysis prescribed by regulation for the substance in relation to which the sample is taken). (2) The medicines and poisons inspector may take as many samples as the inspector considers necessary to allow an accurate analysis to be made, and may deal with each sample in any way that is appropriate in the circumstances, instead of complying with section 135.

Part 7.2 Taking and analysis of samples of substances

137 Certificates of analysis by authorised analysts (1) The analysis of a sample of a substance for the chief health officer must be carried out by, or under the supervision of, an authorised analyst. (2) An authorised analyst who analyses the sample must give to the chief health officer a certificate of analysis that— (a) is signed and dated by the analyst; and (b) contains a written report of the analysis that sets out the findings; and (c) identifies the method of analysis. Note For evidentiary certificates by authorised analysts, see the Public Health Act 1997, s 135A. authorised analyst means an analyst appointed under the Public Health Act 1997, section 15 who is authorised under that Act to exercise a function under this Act.

Chapter 8 Restrictions on dealing with regulated substances and Part 8.1 Authorisations—disciplinary action 138 Application—pt 8.1 (1) This part does not apply in relation to a dealing by a person with a regulated substance or regulated therapeutic good if the dealing is— (a) authorised by a licence or permit under a Commonwealth Act; or (b) the dealing is otherwise in accordance with a Commonwealth Act. (2) To remove any doubt, this part does not limit the power of anyone exercising a function under this Act to— (a) make a notification under the Health Practitioner Regulation National Law (ACT) about a health practitioner; or (b) make a complaint under the Veterinary Practice Act 2018, part 5 about a veterinary practitioner. Note Function includes authority, duty and power (see Legislation Act, dict, pt 1).

139 Definitions—pt 8.1 authorisation holder means a person who is, or has been, authorised to deal with a regulated substance or regulated therapeutic good. disciplinary action—see section 141. disciplinary notice—see section 142. ground for disciplinary action, against an authorisation holder—see section 140. interstate wholesaler means a person who is or has been authorised under— (a) section 20 (4) (When authorised to deal with regulated substances) to supply a regulated substance by wholesale; or (b) section 22 (2) (When authorised to deal with regulated therapeutic goods) to supply a regulated therapeutic good by wholesale.

140 Grounds for disciplinary action against authorisation holders (1) Each of the following is a ground for disciplinary action against an authorisation holder: (a) the authorisation holder has given information to the chief health officer that was false or misleading in a material particular; (b) the authorisation holder has failed to give information required to be given under this Act; (c) the authorisation holder has contravened a condition of the authorisation;

(d) the authorisation holder, or an agent or employee of the authorisation holder, has contravened this Act (whether or not the authorisation holder or employee is convicted, or found guilty, of the offence); Note A reference to an Act includes a reference to the statutory instruments made or in force under the Act, including any regulation (see Legislation Act, s 104). (e) if the authorisation holder is or has been a licence-holder— (i) when the chief health officer issued the licence, grounds existed to refuse the application for the licence but the chief health officer was not aware of them; or (ii) the licence-holder is not, or is no longer, a suitable person for a licence; or (iii) the licence-holder no longer carries out the dealing to which the licence relates; or (iv) a ground mentioned in paragraph (a), (b), (c) or (d) applies in relation to a close associate of, or influential person for, the licence-holder; or (v) a close associate of, or influential person for, the licence-holder is not, or is no longer, a suitable person for the licence; (f) if the person is or was an interstate wholesaler— (i) the person, or an agent or employee of the person, supplied a regulated substance or regulated therapeutic good to someone not authorised to obtain it; or (ii) the person, or an agent or employee of the person, contravened a condition or restriction that applies or applied to the person under a corresponding law or a

(2) In subsection (1) (d), a reference to a contravention of this Act includes a reference to the following: (a) a contravention of the Criminal Code in relation to a document completed, kept or given, or required to be completed, kept or given, under this Act; (b) a contravention of the Criminal Code in relation to anything else done, or not done, under this Act. Note See also the Criminal Code, pt 2.4 (Extensions of criminal responsibility) and pt 2.5 (Corporate criminal responsibility). close associate—see section 79. influential person—see section 80.

141 Disciplinary action against authorisation holders (1) Each of the following is disciplinary action when taken against an authorisation holder (other than a former authorisation holder): (a) reprimanding the authorisation holder; (b) requiring the authorisation holder, or an employee of the authorisation holder, to complete a stated course of training to the satisfaction of the chief health officer or another stated person; (c) imposing a condition on the authorisation holder’s authority to deal with a regulated substance or regulated therapeutic good; (d) amending the authorisation holder’s authority to deal with a regulated substance or regulated therapeutic good;

(e) suspending the authorisation holder’s authority to deal with a regulated substance or regulated therapeutic good, or a particular authorised dealing under the authorisation— (i) for a stated period; or (ii) until the authorisation holder, or an employee of the authorisation holder, completes a stated course of training to the satisfaction of the chief health officer or someone else; or (iii) until a stated event happens; (f) cancelling the authorisation holder’s authority to deal with a regulated substance or regulated therapeutic good; (g) if the authorisation holder is an interstate wholesaler— prohibiting the authorisation holder from supplying a regulated substance or regulated therapeutic good by wholesale in the ACT; (h) if the authorisation holder is authorised to access and use the monitored medicines database—amending, suspending or cancelling the authority to access and use the database. (2) Each of the following is disciplinary action when taken against a former authorisation holder: (a) reprimanding the former authorisation holder; (b) disqualifying the former authorisation holder from being authorised, or authorised in a particular way, to deal with a regulated substance or regulated therapeutic good— (i) for a stated period; or (ii) until the former authorisation holder, or an employee of the former authorisation holder, completes a stated course of training to the satisfaction of the chief health officer or someone else; or

(iii) until a stated event happens; (c) if the former authorisation holder was an interstate wholesaler— prohibiting the former authorisation holder from supplying a regulated substance or regulated therapeutic good by wholesale in the ACT.

142 Taking disciplinary action against authorisation holders (1) If the chief health officer is satisfied that a ground for disciplinary action exists, or may exist, in relation to an authorisation holder, the chief health officer may give the authorisation holder a notice (a disciplinary notice). (2) The disciplinary notice must— (a) state the ground for disciplinary action; and (b) tell the authorisation holder that they may, not later than 3 weeks after the day the authorisation holder is given the notice, give a written response to the chief health officer about the notice. (3) If, after considering any response given not later than the end of the 3-week period, the chief health officer is satisfied that a ground for disciplinary action exists in relation to the authorisation holder, the chief health officer may take disciplinary action against the authorisation holder. (4) To remove any doubt, the disciplinary action may consist of 2 or more of the actions mentioned in section 141. (5) The disciplinary action takes effect when the authorisation holder receives written notice of the action or, if the notice states a later time of effect, at the stated time.

143 Immediate suspension of authorisations (1) This section applies if the chief health officer has given, or is considering whether to give, a disciplinary notice to an authorisation holder. (2) The chief health officer may give the authorisation holder a written notice (an immediate suspension notice) suspending— (a) the authorisation holder’s authority to deal with a regulated substance or regulated therapeutic good; or (b) a particular authorised dealing under the authorisation. (3) However, the chief health officer may suspend the authorisation under subsection (2) only if— (a) the chief health officer has taken into account the circumstances leading to the decision to give or consider giving the disciplinary notice and the grounds stated, or that may be stated, in the disciplinary notice; and (b) the chief health officer believes on reasonable grounds that it is in the public interest that the authorisation be suspended before a decision is made whether or not to take action against the authorisation holder under section 142. (4) If an immediate suspension notice is given to the authorisation holder, the authorisation holder’s authority to deal with the regulated substance or regulated therapeutic good to which the authorisation relates is suspended when the notice is given to the authorisation holder. Note If the authorisation is a licence or approval, the licence or approval must be returned to the chief health officer, see s 145.

(5) If the authorisation holder is given an immediate suspension notice because the chief health officer is considering whether to give a disciplinary notice to the authorisation holder, the chief health officer must, as soon as practicable— (a) give a disciplinary notice to the authorisation holder; or (b) tell the authorisation holder in writing that a disciplinary notice will not be given to the authorisation holder. (6) An immediate suspension notice ends— (a) if the chief health officer decides not to give a disciplinary notice to the authorisation holder—when the chief health officer tells the authorisation holder about the decision under subsection (5) (b); or (b) if a disciplinary notice is given to the authorisation holder— (i) when any disciplinary action takes effect; or (ii) the authorisation holder is given written notice by the chief health officer that no disciplinary action will be taken.

144 Effect of suspension of authorisations (1) If an authorisation to deal with a regulated substance or regulated therapeutic good is suspended, the authorisation does not authorise the authorisation holder to carry on any dealing with the regulated substance or regulated therapeutic good under the authorisation during the suspension. (2) If an authorised dealing with a regulated substance or regulated therapeutic good under an authorisation is suspended, the authorisation— (a) does not authorise the authorisation holder to carry out the dealing under the authorisation during the suspension; and (b) is taken to be amended under this part to the extent necessary to give effect to the suspension.

145 Return of certain licences and approvals (a) the person is the holder of— (i) a licence; or (ii) an approval under section 20 (1) (c) (When authorised to deal with regulated substances) or section 22 (1) (c) (When authorised to deal with regulated therapeutic goods); and (b) the person’s authorisation to deal with a regulated substance or regulated therapeutic good is amended, suspended or cancelled under this part; and (c) the person fails to return the licence or approval to the chief health officer as soon as practicable (but not later than 7 days) after the day the person is told about the amendment, suspension or cancellation. Maximum penalty: 20 penalty units.

146 Action by chief health officer in relation to certain licences and approvals (1) If a licence or approval amended under this part is returned to the chief health officer, the chief health officer must— (a) amend the licence or approval and return it to the authorisation holder; or (b) give the authorisation holder a replacement licence or approval that includes the amendment. Note A licence or approval is taken to be amended if an authorised dealing under the licence or approval is suspended (see s 144 (2)).

(2) If a licence or approval is suspended under this part and the suspension ends before the end of the term of the licence or approval, the chief health officer must— (a) return the licence or approval to the authorisation holder; or (b) give the authorisation holder a replacement licence or approval for the remainder of the term of the licence or approval. approval means an approval under section 20 (1) (c) (When authorised to deal with regulated substances) or section 22 (1) (c) (When authorised to deal with regulated therapeutic goods).

Controlled medicines and prohibited substances—disqualification by courts

Part 8.2 Part 8.2 Controlled medicines and prohibited substances— disqualification by courts

147 Definitions—pt 8.2 drug offence means an offence against— (a) chapter 4 (Offences relating to regulated substances) in relation to a controlled medicine or prohibited substance; or (b) the Criminal Code, chapter 6 (Serious drug offences); or (c) the Drugs of Dependence Act 1989, part 10 (Offences). relevant person means— (a) a person who is authorised to deal with a regulated substance; or (b) a person who is authorised under this Act or another territory law to possess a controlled medicine or prohibited substance.

148 Drug offences—disqualification from dealing (1) This section applies if a relevant person is convicted, or found guilty, of a drug offence. (2) The convicting court may direct that the relevant person must not, during a stated period, deal with a controlled medicine or prohibited substance (or both) in the ways stated in the direction. (3) However, the court must not give the direction unless satisfied that giving the direction is in the interests of the person or the public. (4) The Magistrates Court Act 1930, section 208 (which is about appeals in criminal matters) applies in relation to the direction as if the direction were a penalty imposed by the court in relation to the conviction of a person of an offence.

Part 8.2 Controlled medicines and prohibited substances—disqualification by courts

149 Notice of disqualification from dealing (1) If a court gives a direction under section 148 (2), the court’s registrar must give a copy of the direction to— (a) the relevant person; and (b) the chief health officer. (2) The chief health officer must give a copy of the direction to— (a) the relevant person’s employer (if any); and (b) if the relevant person is a veterinary practitioner—the veterinary practitioners board; and (c) if the relevant person is a health practitioner—the relevant national board for the person under the Health Practitioner Regulation National Law (ACT).

150 Effect of disqualification from dealing (1) This section applies if a direction is given under section 148 (2) (Drug offences—disqualification from dealing) in relation to a relevant (2) The relevant person’s authorisation to deal with a controlled medicine or prohibited substance is taken, to the extent necessary to give effect to the court’s direction, not to be in force for the period stated in the direction.

Surrender of prescribed authorisations Part 8.3 Part 8.3 Surrender of prescribed authorisations

151 Application—pt 8.3 This part applies to a person who is authorised under a regulation to deal with a regulated substance or regulated therapeutic good, other than— (a) a licence-holder; or Note For the surrender of a licence, see s 97. (b) a person who is dealing with a medicine or poison in accordance with an approval by the chief health officer under a regulation; or Note The approval may be revoked by the chief health officer (see Legislation Act, s 46 (1)). (c) a medicines and poisons inspector; or (d) a person prescribed by regulation.

152 Surrender of authorisation under regulation (1) A person to whom this part applies may, by written notice (a surrender notice) given to the chief health officer, declare that the person does not wish to be authorised under a regulation— (a) to deal with a stated regulated substance or regulated therapeutic good; or (b) for stated dealings with a stated regulated substance or regulated therapeutic good.

Part 8.3 Surrender of prescribed authorisations (2) A surrender notice— (a) may state a period during which the declaration is to apply or an event on which the declaration ends; and (b) may be revoked by giving the chief health officer written notice of the revocation at least 7 days before the revocation takes effect. (3) If the chief health officer receives from a person a surrender notice or notice revoking a surrender notice, the chief health officer must give a copy of the notice to— (a) the person’s employer (if any); and (b) if the relevant person is a veterinary practitioner—the veterinary practitioners board; and (c) if the relevant person is a health practitioner—the relevant national board for the person under the Health Practitioner Regulation National Law (ACT).

153 Effect of surrender of authorisation under regulation (1) This section applies while a surrender notice under section 152 relating to a regulated substance or regulated therapeutic good is in force in relation to a person. (2) The person’s authorisation to deal with the regulated substance or regulated therapeutic good is taken, to the extent necessary to give effect to the surrender notice, not to be in force while the notice is in force.

Notification and review of decisions Chapter 9

Chapter 9 Notification and review of decisions

154 Meaning of reviewable decision—ch 9 reviewable decision means a decision mentioned in schedule 1, column 3 under a provision of this Act mentioned in column 2 in relation to the decision.

155 Reviewable decision notices If a person makes a reviewable decision, the person must give a reviewable decision notice to each entity mentioned in schedule 1, column 4 in relation to the decision. Note The person must also take reasonable steps to give a reviewable decision notice to any other person whose interests are affected by the decision (see ACT Civil and Administrative Tribunal Act 2008, s 67A).

155A Applications for review The following may apply to the ACAT for a review of a reviewable decision: (a) an entity mentioned in schedule 1, column 4 in relation to the decision; (b) any other person whose interests are affected by the decision.

Chapter 10 Incorporation of Commonwealth therapeutic