{"id":"a-2008-26","name":"Medicines, Poisons and Therapeutic Goods Act 2008","slug":"medicines-poisons-and-therapeutic-goods-act-2008","collection":"act","jurisdiction":"act","status":"in_force","isInForce":true,"actNumber":"26 of 2008","makingDate":null,"administeringDepartment":null,"currentVersion":{"id":23931,"registerId":"act-a-2008-26-current","compilationNumber":null,"startDate":"2026-04-01","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"26","sectionType":"section","heading":"November 2025. It also includes any commencement, amendment, repeal or expiry affecting","content":"26 November 2025. It also includes any commencement, amendment, repeal or expiry affecting\nthis republished law to 26 November 2025.\nThe legislation history and amendment history of the republished law are set out in endnotes 3\nand 4.\nKinds of republications\nThe Parliamentary Counsel’s Office prepares 2 kinds of republications of ACT laws (see the ACT\nlegislation register at www.legislation.act.gov.au):\n• authorised republications to which the Legislation Act 2001 applies\n• unauthorised republications.\nThe status of this republication appears on the bottom of each page.\nEditorial changes\nThe Legislation Act 2001, part 11.3 authorises the Parliamentary Counsel to make editorial\namendments and other changes of a formal nature when preparing a law for republication.\nEditorial changes do not change the effect of the law, but have effect as if they had been made by\nan Act commencing on the republication date (see Legislation Act 2001, s 115 and s 117). The\nchanges are made if the Parliamentary Counsel considers they are desirable to bring the law into\nline, or more closely into line, with current legislative drafting practice.\nThis republication includes amendments made under part 11.3 (see endnote 1).\nUncommenced provisions and amendments\nIf a provision of the republished law has not commenced, the symbol U appears immediately\nbefore the provision heading. Any uncommenced amendments that affect this republished law\nare accessible on the ACT legislation register (www.legislation.act.gov.au). For more\ninformation, see the home page for this law on the register.\nModifications\nIf a provision of the republished law is affected by a current modification, the\nsymbol M appears immediately before the provision heading. The text of the modifying\nprovision appears in the endnotes. For the legal status of modifications, see the Legislation\nAct 2001, section 95.\nPenalties\nAt the republication date, the value of a penalty unit for an offence against this law is $160 for an\nindividual and $810 for a corporation (see Legislation Act 2001, s 133).\n\ncontents 1\nPage\n1 Name of Act 2\n3 Dictionary 2\n4 Notes 2\n5 Offences against Act—application of Criminal Code etc 2\n6 Objects 3\n7 Appropriate prescription and supply of medicines 4\n8 Obligations under other territory laws 4\n9 Inconsistency between Act and medicines and poisons standard 4\n\nPage\ncontents 2 Medicines, Poisons and Therapeutic Goods Act 2008\n9A Application of Act to certain cannabis use not prohibited under Drugs\nof Dependence Act 1989 5\n10 Meaning of regulated substance—Act 6\n11 Medicine-related definitions 6\n12 Poison-related definitions 7\n13 Meaning of prohibited substance and schedule 10 substance—Act 8\nPart 3.2 Therapeutic goods to which Act applies\n14 Meaning of regulated therapeutic good—Act 9\n15 Meaning of medicines and poisons standard—Act 10\n16 Interpretation provisions in medicines and poisons standard—\napplication to Act 10\n17 When medicines and poisons standard applies to substances 11\n18 Inspection of medicines and poisons standard 12\n19 Meaning of deals with a regulated substance—Act 13\n20 When authorised to deal with regulated substances 14\n21 Meaning of deals with a regulated therapeutic good—Act 17\n22 When authorised to deal with regulated therapeutic goods 17\n23 Meaning of supply authority—Act 18\n24 Meaning of possess, sell and supply—Act 18\nPart 4.1 Dealings with regulated substances—\noffences\n25 Meaning of declared substance—pt 4.1 20\n\nPage\ncontents 3\n26 Supplying declared substances 20\n27 Supplying declared substances on invalid supply authorities—strict\nliability offences 21\n28 Supplying declared substances on invalid supply authorities—\nrecklessness 22\n29 Supplying declared substances on invalid supply authorities—other\noffences 23\n30 Cancellation etc of invalid supply authorities for declared substances 24\n31 Supply of certain declared substances—information for chief health\nofficer 25\n32 Information about invalid supply authorities for chief health officer 26\n33 Manufacturing regulated substances 29\n34 Discarding declared etc substances 29\n35 Obtaining certain declared substances 31\n36 Possessing certain declared substances 31\n37 Administering certain declared substances 32\n38 Issuing purchase orders for declared substances 33\n39 Reporting loss and theft of certain regulated substances 34\n40 Prescribing medicines 35\n41 Issuing requisitions for medicines 36\n42 Issuing standing orders for medicines 36\n43 Medicines for animals not to be prescribed etc for human use 37\n44 Contravening authorisation conditions for regulated substances 38\n45 Pretending to be authorised to deal with regulated substance 39\n46 Accessibility of records 40\n47 Keeping cancelled invalid supply authorities 41\n48 Meaning of must keep register—div 4.2.2 41\n49 Registers—not keeping 42\n\nPage\ncontents 4 Medicines, Poisons and Therapeutic Goods Act 2008\n50 Registers—where to be kept 42\n51 Registers—duty to ensure entries made 43\n52 Registers—signing entries 43\n53 Registers—witnessing administration of medicines 43\n54 Registers—witnessing discarding 44\n55 Registers—changes etc to entries 45\n56 Registers—period to be kept 45\n57 Registers—damage or loss 45\n58 Transferring responsibility for community pharmacies—stocktake etc\nof controlled medicines 47\n59 Packaging of supplied regulated substances 50\n60 Labelling of supplied regulated substances 51\n61 Storing declared substances 52\nDivision 4.3.3 Containers—offences\n62 Permanently named containers—use for other regulated substances 52\n63 Certain containers not to be used for human-use substances 53\n64 False statements to obtain certain regulated substances etc 53\n65 Falsely representing substance is regulated 55\n66 Advertising controlled medicines and prohibited substances 56\n67 Meaning of vending machine—div 4.3.5 57\n68 Vending machines—use for supply of regulated substances 57\n69 Vending machines—use for supply of unscheduled medicines 58\n70 Manufacture, supply and use of paints containing white lead 59\n71 Manufacture, supply and use of paints for certain purposes 60\n72 Manufacture, supply and use of paints for toys 60\n73 Manufacture, supply and use of paints containing pesticides 60\n\nPage\ncontents 5\nChapter 5 Offences relating to regulated therapeutic\n74 Supplying regulated therapeutic goods 62\n75 Contravening authorisation conditions for regulated therapeutic goods 63\n76 Pretending to be authorised to deal with regulated therapeutic goods 63\n77 Falsely representing thing is regulated 63\nChapter 6 Licences for regulated substances and\n78 Meaning of licence etc—ch 6 65\n79 Meaning of close associate—ch 6 65\n80 Meaning of influential person for corporation—ch 6 66\n81 Suitability of individuals for licences 67\n82 Suitability of corporations for licences 69\n83 Power to ask for information etc from applicants and others 70\n84 Applications for licences 72\n85 Decision on applications for licences 72\n86 Term of licences 73\n87 Licences not transferable 73\n88 Form of licences 73\n89 Statutory licence conditions 74\n90 Other licence conditions 74\n91 Amending licence on chief health officer’s initiative 75\n92 Amending licence on application by licence-holder 76\n93 Licensee to keep chief health officer informed 76\n94 Returning licences for amendment 77\n95 Replacing licences 78\nPart 6.3 Licences—other provisions\n96 Contravening licence conditions 79\n\nPage\ncontents 6 Medicines, Poisons and Therapeutic Goods Act 2008\n97 Surrendering licences 79\n97A Meaning of monitored medicine 80\n97B Definitions—ch 6A 80\n97C Monitored medicines database—purposes 81\n97D Monitored medicines database—scope 81\n97E Monitored medicines database—chief health officer functions 82\n97F Monitored medicines database—access and use by relevant health\npractitioners 83\n97G Monitored medicines database—access authority 83\n97H Monitored medicines database—offences 84\n98 Definitions—pt 7.1 86\n99 Meaning of medicines and poisons inspector—Act 86\nDivision 7.1.2 Medicines and poisons inspectors\n100 Appointment of medicines and poisons inspectors 87\n101 Identity cards 87\n102 Power to enter premises 88\n103 Production of identity card 89\n104 Consent to entry 89\n105 General powers on entry to premises 90\n106 Power to seize things 91\n107 Power to destroy unsafe things 92\n108 Power to require name and address 94\n109 Warrants generally 94\n110 Warrants—application made other than in person 96\n\nPage\ncontents 7\n111 Search warrants—announcement before entry 97\n112 Details of search warrant to be given to occupier etc 98\n113 Occupier entitled to be present during search etc 98\n114 Moving things to another place for examination or processing 99\n115 Use of electronic equipment at premises 100\n116 Person with knowledge of computer to assist access etc 101\n117 Securing electronic equipment 102\n118 Copies of seized things to be provided 104\n119 Receipt for things seized 105\n120 Access to things seized 105\n121 Return of things seized 106\n122 Application for order disallowing seizure 107\n123 Order for return of seized thing 108\n124 Adjournment pending hearing of other proceedings 109\n125 Forfeiture of seized things 109\n126 Return of forfeited things 110\n127 Cost of disposal of forfeited things 110\nDivision 7.1.6 Medicines and poisons inspectors—other provisions\n128 Disposal etc of things obtained otherwise than under pt 7.1 111\n129 Damage etc to be minimised 111\n130 Compensation for exercise of enforcement powers 112\nPart 7.2 Taking and analysis of samples of\n131 Inspector may buy samples without complying with pt 7.2 113\n132 Person in charge etc to be told sample to be analysed 113\n133 Payment for samples 114\n134 Samples from packaged substances 114\n135 Procedures for dividing samples 114\n136 Exception to usual procedures for dividing samples 115\n137 Certificates of analysis by authorised analysts 116\n\nPage\ncontents 8 Medicines, Poisons and Therapeutic Goods Act 2008\nChapter 8 Restrictions on dealing with regulated\nsubstances and regulated therapeutic goods\n138 Application—pt 8.1 117\n139 Definitions—pt 8.1 118\n140 Grounds for disciplinary action against authorisation holders 118\n141 Disciplinary action against authorisation holders 120\n142 Taking disciplinary action against authorisation holders 122\n143 Immediate suspension of authorisations 123\n144 Effect of suspension of authorisations 124\n145 Return of certain licences and approvals 125\n146 Action by chief health officer in relation to certain licences and\napprovals 125\nPart 8.2 Controlled medicines and prohibited\nsubstances—disqualification by courts\n147 Definitions—pt 8.2 127\n148 Drug offences—disqualification from dealing 127\n149 Notice of disqualification from dealing 128\n150 Effect of disqualification from dealing 128\nPart 8.3 Surrender of prescribed authorisations\n151 Application—pt 8.3 129\n152 Surrender of authorisation under regulation 129\n153 Effect of surrender of authorisation under regulation 130\nChapter 9 Notification and review of decisions\n154 Meaning of reviewable decision—ch 9 131\n155 Reviewable decision notices 131\n155A Applications for review 131\n\nPage\ncontents 9\nChapter 10 Incorporation of Commonwealth therapeutic\n156 Definitions—ch 10 132\nPart 10.2 Application in ACT of Commonwealth\ntherapeutic goods laws\n157 Application of Commonwealth therapeutic goods laws to ACT 134\n158 Interpretation of Commonwealth therapeutic goods laws 134\nDivision 10.2.2 Functions under applied provisions\n159 Functions of Commonwealth Minister 135\n160 Functions of Commonwealth Secretary 135\n161 Functions of other people 135\n162 Delegations by Commonwealth Minister or Secretary 135\n163 Appointments under Commonwealth therapeutic goods laws 136\nDivision 10.2.3 Applied provisions—administrative law matters\n164 Application of Commonwealth administrative laws to applied\nprovisions 136\n165 Functions given to Commonwealth officers and authorities 137\n166 Object—div 10.2.4 137\n167 Application of Commonwealth criminal laws to offences against\napplied provisions 138\n168 Functions of Commonwealth officers and authorities relating to\noffences 139\n169 No double jeopardy for offences against applied provisions 139\n170 Commonwealth may keep fees paid to Commonwealth Secretary 140\n\nPage\ncontents 10 Medicines, Poisons and Therapeutic Goods Act 2008\nPart 11.1 General provisions about offences against\nAct\n171 Acts and omissions of representatives of individuals 141\n172 Criminal liability of executive officers 143\n173 No defence to claim deterioration of sample 146\n174 Remedial orders by court for offences 146\n175 Court may order costs and expenses 147\n176 Court may order forfeiture 147\n177 Notices of noncompliance by territory entities 147\n178 Evidence—authorisations under Commonwealth and State laws 149\n179 Presumptions 149\n180 Certificate evidence etc 150\n181 Admissibility of analysis of samples taken by inspectors 151\n182 Power of court to order further analysis 151\nChapter 12 Regulations about regulated substances and\n183 Meaning of regulated thing—ch 12 153\n184 Regulation-making power 153\n185 Regulations—regulated things 153\n186 Regulations—authorisations 154\n187 Regulations—records kept electronically 155\n188 Regulations—medicines advisory committee 156\n189 Regulations—application etc of instruments 156\n190 Regulations—exemption of people, dealings etc 156\n191 Directions about dealings with regulated substances and therapeutic\ngoods 158\n\nPage\ncontents 11\n192 Guidelines about dealings with regulated substances and therapeutic\ngoods 159\n193 Approval of non-standard packaging and labelling 159\n194 Establishment of medicines advisory committee 159\n195 Secrecy 159\n196 Protection of officials from liability 161\n197 Determination of fees 161\nSchedule 1 Reviewable decisions 162\nDictionary 165\n1 About the endnotes 173\n2 Abbreviation key 173\n3 Legislation history 174\n4 Amendment history 179\n5 Earlier republications 187\n\nAn Act to consolidate and reform the law relating to regulated substances and\nregulated therapeutic goods, to give effect to the medicines and poisons standard,\nand for other purposes\n\n","sortOrder":0},{"sectionNumber":"1","sectionType":"section","heading":"Name of Act","content":"1 Name of Act\nThis Act is the Medicines, Poisons and Therapeutic Goods Act 2008.\n","sortOrder":1},{"sectionNumber":"3","sectionType":"section","heading":"Dictionary","content":"3 Dictionary\nThe dictionary at the end of this Act is part of this Act.\nNote 1 The dictionary at the end of this Act defines certain terms used in this\nAct, and includes references (signpost definitions) to other terms defined\nelsewhere in this Act.\nFor example, the signpost definition ‘authorisation holder, for part 8.1\n(Authorisations—disciplinary action)—see section 139.’ means that the\nterm ‘authorisation holder’ is defined in that section for part 8.1.\nNote 2 A definition in the dictionary (including a signpost definition) applies to\nthe entire Act unless the definition, or another provision of the Act,\nprovides otherwise or the contrary intention otherwise appears (see\nLegislation Act, s 155 and s 156 (1)).\n","sortOrder":2},{"sectionNumber":"4","sectionType":"section","heading":"Notes","content":"4 Notes\nA note included in this Act is explanatory and is not part of this Act.\nNote See the Legislation Act, s 127 (1), (4) and (5) for the legal status of notes.\n","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Offences against Act—application of Criminal Code etc","content":"5 Offences against Act—application of Criminal Code etc\nOther legislation applies in relation to offences against this Act.\nNote 1 Criminal Code\nThe Criminal Code, ch 2 applies to all offences against this Act (see\nCode, pt 2.1).\nThe chapter sets out the general principles of criminal responsibility\n(including burdens of proof and general defences), and defines terms used\nfor offences to which the Code applies (eg conduct, intention,\nrecklessness and strict liability).\nNote 2 Penalty units\nThe Legislation Act, s 133 deals with the meaning of offence penalties\nthat are expressed in penalty units.\n\nOperation of Act Chapter 2\n","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Objects","content":"6 Objects\n(1) The main object of this Act is to promote and protect public health\nand safety by minimising—\n(a) accidental and deliberate poisonings by regulated substances;\nand\n(b) medicinal misadventures related to regulated substances; and\n(c) the diversion of regulated substances for abuse; and\n(d) the manufacture of regulated substances that are subject to\nabuse; and\n(e) harm from regulated therapeutic goods.\n(2) The objects of this Act also include ensuring that—\n(a) consumers of prescription medicines have adequate information\nand the understanding necessary to allow them to use the\nmedicines safely and effectively; and\n(b) consumers of non-prescription medicines have adequate\ninformation and the understanding to allow them to select the\nmost appropriate medicines for their condition and to use the\nmedicines safely and effectively, taking into account the\ncondition of their health.\n(3) In regulating the dealings of health practitioners or veterinary\npractitioners with regulated substances, the chief health officer may,\nbut need not, choose to take disciplinary action rather than pursuing\nprosecutions under this Act if the chief health officer believes it\nwould be in the public interest to do so.\n\nnon-prescription medicine means a medicine other than a\nprescription medicine.\nprescription medicine means a prescription only medicine or\ncontrolled medicine.\n","sortOrder":5},{"sectionNumber":"7","sectionType":"section","heading":"Appropriate prescription and supply of medicines","content":"7 Appropriate prescription and supply of medicines\n(1) A health practitioner or a veterinary practitioner who prescribes or\nsupplies a medicine must ensure that the prescription or supply of the\nmedicine is for a quantity and purpose that is consistent with the\nrecognised therapeutic standard of what is appropriate in the\ncircumstances.\n(2) Subsection (1) does not apply to wholesale supply.\n","sortOrder":6},{"sectionNumber":"8","sectionType":"section","heading":"Obligations under other territory laws","content":"8 Obligations under other territory laws\nThe obligations under this Act are additional to the obligations under\nany other territory law unless this Act, or the other law, provides\notherwise.\nIf there is an obligation under the Dangerous Substances Act 2004 and under this\nAct in relation to a particular substance, both obligations must be complied with in\nrelation to the substance unless either Act provides otherwise.\n","sortOrder":7},{"sectionNumber":"9","sectionType":"section","heading":"Inconsistency between Act and medicines and poisons","content":"9 Inconsistency between Act and medicines and poisons\nstandard\nThis Act prevails if there is an inconsistency between this Act and the\nmedicines and poisons standard.\n\nOperation of Act Chapter 2\n","sortOrder":8},{"sectionNumber":"9A","sectionType":"section","heading":"Application of Act to certain cannabis use not prohibited","content":"9A Application of Act to certain cannabis use not prohibited\nunder Drugs of Dependence Act 1989\n(1) The defined provisions of this Act do not apply to an adult to the\nextent that the substance is an amount of cannabis that the adult is not\nprohibited from cultivating or possessing under the Drugs of\nDependence Act 1989.\ndefined provisions of this Act means the following:\n(a) section 26 (2) (Supplying declared substances);\n(b) section 33 (Manufacturing regulated substances);\n(c) section 35 (1) (Obtaining certain declared substances);\n(d) section 36 (Possessing certain declared substances);\n(e) section 37 (2) (Administering certain declared substances).\n\n","sortOrder":9},{"sectionNumber":"10","sectionType":"section","heading":"Meaning of regulated substance—Act","content":"10 Meaning of regulated substance—Act\nregulated substance means a medicine, poison, prohibited substance\nor schedule 10 substance.\n","sortOrder":10},{"sectionNumber":"11","sectionType":"section","heading":"Medicine-related definitions","content":"11 Medicine-related definitions\nmedicine means—\n(a) a pharmacy medicine; or\n(b) a pharmacist only medicine; or\n(c) a prescription only medicine; or\n(d) a controlled medicine.\n(2) In this Act:\ncontrolled medicine means a substance to which the medicines and\npoisons standard, schedule 8 applies.\nNote Schedule 8 medicines are prescription medicines that have additional\nrestrictions to reduce misuse or dependence. The schedule includes some\nderivatives of the scheduled medicines (see s 16 (2)).\npharmacist only medicine means a substance to which the medicines\nand poisons standard, schedule 3 applies.\nNote Schedule 3 medicines are medicines that require advice from a\npharmacist to be used safely. The schedule includes some derivatives of\nthe scheduled medicines (see s 16 (2)).\n\nSubstances to which Act applies Part 3.1\npharmacy medicine means a substance to which the medicines and\npoisons standard, schedule 2 applies.\nNote Schedule 2 medicines are medicines that may require advice from a\npharmacist to be used safely. The schedule includes some derivatives of\nthe scheduled medicines (see s 16 (2)).\nprescription only medicine means a substance to which the medicines\nand poisons standard, schedule 4 applies.\nNote Schedule 4 medicines are medicines (including prescription animal\nremedies) that are available from a pharmacy on prescription. The\nschedule includes some derivatives of the scheduled medicines\n","sortOrder":11},{"sectionNumber":"12","sectionType":"section","heading":"Poison-related definitions","content":"12 Poison-related definitions\npoison means—\n(a) a low harm poison; or\n(b) a moderate harm poison; or\n(c) a dangerous poison.\n(2) In this Act:\ndangerous poison means a substance to which the medicines and\npoisons standard, schedule 7 applies.\nNote Schedule 7 applies to substances with a high potential for causing harm.\nThe schedule includes some derivatives of the scheduled substances\nlow harm poison means a substance to which the medicines and\npoisons standard, schedule 5 applies.\nNote Schedule 5 applies to substances with a low potential for causing harm.\nThe schedule includes some derivatives of the scheduled substances\n\nmoderate harm poison means a substance to which the medicines and\npoisons standard, schedule 6 applies.\nNote Schedule 6 applies to substances with a moderate potential for causing\nharm. The schedule includes some derivatives of the scheduled\nsubstances (see s 16 (2)).\n","sortOrder":12},{"sectionNumber":"13","sectionType":"section","heading":"Meaning of prohibited substance and schedule 10","content":"13 Meaning of prohibited substance and schedule 10\nsubstance—Act\nprohibited substance—\n(a) means a substance to which the medicines and poisons standard,\nschedule 9 applies; but\n(b) does not include cannabis food products.\nNote Sch 9 substances are generally illegal substances that are subject to abuse.\nThey include some derivatives of the scheduled substances (see s 16 (2)).\nschedule 10 substance means a substance to which the medicines and\npoisons standard, schedule 10 applies.\nNote Sch 10 substances are substances, other than those in sch 9, the sale,\nsupply and use of which is prohibited because of the degree of danger to\nhealth they represent. The schedule includes some derivatives of the\nsubstances to which the schedule applies (see s 16 (2)).\ncannabis food product—see the Drugs of Dependence Act 1989,\nsection 6.\n\nTherapeutic goods to which Act applies Part 3.2\n","sortOrder":13},{"sectionNumber":"Part 3","sectionType":"part","heading":"2 Therapeutic goods to which Act","content":"Part 3.2 Therapeutic goods to which Act\napplies\n","sortOrder":14},{"sectionNumber":"14","sectionType":"section","heading":"Meaning of regulated therapeutic good—Act","content":"14 Meaning of regulated therapeutic good—Act\nregulated therapeutic good means—\n(a) any of the following within the meaning of the Therapeutic\nGoods Act 1989 (Cwlth) as prescribed by regulation:\n(i) a therapeutic good (other than a regulated substance);\n(ii) a medical device; or\n(b) anything else (other than a regulated substance) prescribed by\n\n","sortOrder":15},{"sectionNumber":"15","sectionType":"section","heading":"Meaning of medicines and poisons standard—Act","content":"15 Meaning of medicines and poisons standard—Act\nmedicines and poisons standard means the poisons standard, as in\nforce from time to time and as modified by regulation (if any).\nNote For the public availability and inspection of a copy of the medicines and\npoisons standard, see s 18.\n(2) For subsection (1), but subject to any modification prescribed by\nregulation, an amendment of a current poisons standard or a new\npoisons standard takes effect in accordance with the Legislation\nAct 2003 (Cwlth), section 12.\ncurrent poisons standard—see the Therapeutic Goods Act 1989\n(Cwlth), section 52A (1), definition of current Poisons Standard.\nnew poisons standard means a document prepared under the\nTherapeutic Goods Act 1989 (Cwlth), section 52D (2) (b).\npoisons standard means a document made under the Therapeutic\nGoods Act 1989 (Cwlth), section 52D (2).\n","sortOrder":16},{"sectionNumber":"16","sectionType":"section","heading":"Interpretation provisions in medicines and poisons","content":"16 Interpretation provisions in medicines and poisons\nstandard—application to Act\n(1) A term defined in the medicines and poisons standard has the same\nmeaning in this Act.\n\nMedicines and poisons standard Part 3.3\n(2) A provision of the medicines and poisons standard relating to the\ninterpretation of the standard applies in the interpretation of this Act.\nIf the medicines and poisons standard provides that, subject to stated exceptions, a\nreference to a substance in a schedule or appendix to the standard includes every\nsalt, active principle or derivative of the substance, then a reference to the substance\nin this Act includes, subject to the exceptions, a reference to each salt, active\nprinciple or derivative of the substance.\n","sortOrder":17},{"sectionNumber":"17","sectionType":"section","heading":"When medicines and poisons standard applies to","content":"17 When medicines and poisons standard applies to\nFor this Act, a schedule or appendix of the medicines and poisons\nstandard applies to a substance in a circumstance if—\n(a) the substance is included in the schedule or appendix; and\n(b) either—\n(i) an exclusion in the standard does not, in the circumstance,\nexclude the substance from the operation of the schedule\nor appendix; or\n(ii) if a restriction is mentioned in the standard for the\nsubstance—the restriction applies in relation to the\nsubstance in the circumstance.\nExample—par (b) (ii)\nSubstance X is included in sch 4 (Prescription only medicine) of the\nmedicines and poisons standard. Its listing is followed by the\nrestriction ‘for human therapeutic use’. Substance X is not included\nin another schedule or an appendix of the standard. The standard\napplies to substance X only for human therapeutic use.\nNote See also s 9 (Inconsistency between Act and medicines and\npoisons standard).\n\n","sortOrder":18},{"sectionNumber":"18","sectionType":"section","heading":"Inspection of medicines and poisons standard","content":"18 Inspection of medicines and poisons standard\nThe chief health officer must ensure that a copy of the medicines and\npoisons standard (including any amendments of the standard) is made\navailable for inspection free of charge to the public on business days\nat reasonable times at an office administered by the chief health\nofficer.\n\n","sortOrder":19},{"sectionNumber":"19","sectionType":"section","heading":"Meaning of deals with a regulated substance—Act","content":"19 Meaning of deals with a regulated substance—Act\n(1) For this Act, a person deals with a regulated substance if the person\ndoes 1 or more of the following:\n(a) manufactures the substance;\n(b) obtains the substance;\n(c) possesses the substance;\n(d) supplies the substance;\n(e) administers the substance;\n(f) discards the substance;\n(g) issues a purchase order for the substance;\n(h) if the substance is a medicine—\n(i) prescribes the medicine; or\n(ii) issues a requisition or standing order for the medicine;\n(i) if the substance is a dangerous poison, prohibited substance or\nschedule 10 substance—gives a written or oral direction to—\n(i) supply the poison or substance for administration to a\nperson; or\n(ii) administer the poison or substance to a person.\n(2) For this Act, a person also deals with a regulated substance if the\nregulated substance otherwise comes into, or goes out of, the person’s\npossession, including, for example, if the person loses or finds the\nregulated substance or the substance is stolen from the person.\n\n","sortOrder":20},{"sectionNumber":"20","sectionType":"section","heading":"When authorised to deal with regulated substances","content":"20 When authorised to deal with regulated substances\n(1) For this Act, a person is authorised to deal with a medicine, low harm\npoison or moderate harm poison if—\n(a) the person has a licence or permit under a Commonwealth Act,\nthis Act or another territory law that authorises the dealing; or\nNote A reference to an Act includes a reference to statutory instruments\nmade or in force under the Act, including any regulation and any\nlaw or instrument applied, adopted or incorporated by the Act (see\nLegislation Act, s 104).\n(b) the person may or must deal with the medicine or poison under\na Commonwealth Act, this Act or another territory law; or\n(c) the chief health officer approves the dealing under a regulation;\nor\n(d) the dealing is otherwise authorised by regulation.\nExamples of Commonwealth Acts—pars (a) and (b)\nCustoms (Prohibited Imports) Regulations 1956, Narcotic Drugs Act 1967 and\nTherapeutic Goods Act 1989\nExamples of when person may or must deal with medicines—par (b)\n1 the person is a dentist and a regulation allows dentists to administer the\nmedicine\n2 the person is authorised under the Health Professionals (Special Events\nExemptions) Act 2000, s 10 (1) to issue a written prescription for the medicine\n3 the person is authorised under the Voluntary Assisted Dying Act 2024, s 66 to\nadminister the medicine\nNote For the supply of a regulated substance by wholesale, see s (4).\n(2) For this Act, a person is authorised to deal with a dangerous poison,\nprohibited substance or schedule 10 substance if—\n(a) the person may or must deal with the poison or substance under\na Commonwealth Act, this Act or another territory law; or\n(b) the person has a licence under this Act that authorises the\ndealing.\n\n(3) However, for subsection (2), a person is authorised for an\nadministration-related dealing with a dangerous poison, prohibited\nsubstance or schedule 10 substance for human use only if—\n(a) the dealing is authorised by a licence for the purposes of research\nat a recognised research institution; and\n(b) the research is approved by a human research ethics committee\nthat is constituted in accordance with, and acting in compliance\nwith, the NHMRC National Statement on Ethical Conduct in\nResearch Involving Humans (1999), as in force from time to\ntime.\nNote Administration-related dealing, NHMRC and recognised research\ninstitution—see s (5).\n(4) Also, for this Act, a person is authorised to supply a regulated\nsubstance by wholesale if—\n(a) the person is authorised (however described) under a\ncorresponding law to supply the substance by wholesale; and\n(b) the person does not have a place of business in the ACT; and\n(c) if a condition or restriction applies to the person under the\ncorresponding law or is prescribed by regulation—the person\ncomplies with each condition or restriction; and\n(d) the chief health officer has not, under part 8.1 (Authorisations—\ndisciplinary action), prohibited the person from supplying the\nsubstance by wholesale in the ACT.\nNote Wholesale—see the dictionary.\n\nadministration-related dealing, in relation to a dangerous poison,\nprohibited substance or schedule 10 substance for human use,\nmeans—\n(a) giving a written or oral direction to administer the poison or\nsubstance, or supply the poison or substance for administration,\nto a person; or\n(b) supplying the poison or substance for administration to a person;\nor\n(c) administering the poison or substance to a person.\nNHMRC means the National Health and Medical Research Council\nunder the National Health and Medical Research Council Act 1992\n(Cwlth).\nrecognised research institution means any of the following:\n(a) the Australian Catholic University;\n(b) the Australian National University;\n(c) a hospital operated by the Territory;\n(d) the Canberra Institute of Technology;\n(e) the Commonwealth Scientific and Industrial Research\nOrganisation;\n(f) the University College within the Australian Defence Force\nAcademy;\n(g) the University of Canberra;\n(h) any other entity prescribed by regulation.\n\n","sortOrder":21},{"sectionNumber":"21","sectionType":"section","heading":"Meaning of deals with a regulated therapeutic good—Act","content":"21 Meaning of deals with a regulated therapeutic good—Act\nFor this Act, a person deals with a regulated therapeutic good if the\nperson supplies the good.\n","sortOrder":22},{"sectionNumber":"22","sectionType":"section","heading":"When authorised to deal with regulated therapeutic","content":"22 When authorised to deal with regulated therapeutic\n(1) For this Act, a person is authorised to deal with a regulated\ntherapeutic good if—\n(a) the person has a licence or permit under a Commonwealth Act,\nthis Act or another territory law that authorises the dealing; or\n(b) the person may or must deal with the good under a\nCommonwealth Act, this Act or another territory law; or\nNote A reference to an Act includes a reference to statutory instruments\nmade or in force under the Act, including any regulation and any\nlaw or instrument applied, adopted or incorporated by the Act (see\nLegislation Act, s 104).\n(c) the chief health officer approves the dealing under a regulation;\nor\n(d) the dealing is otherwise authorised by regulation.\n(2) Also, for this Act, a person is authorised to supply a regulated\ntherapeutic good by wholesale if—\n(a) the person is authorised (however described) under a\ncorresponding law to supply the good by wholesale; and\n(b) the person does not have a place of business in the ACT; and\n(c) if a condition or restriction applies to the person under the\ncorresponding law or is prescribed by regulation—the person\ncomplies with each condition or restriction; and\n\n(d) the chief health officer has not, under part 8.1 (Authorisations—\ndisciplinary action), prohibited the person from supplying the\ngood by wholesale in the ACT.\nNote Wholesale—see the dictionary.\n","sortOrder":23},{"sectionNumber":"23","sectionType":"section","heading":"Meaning of supply authority—Act","content":"23 Meaning of supply authority—Act\nsupply authority—each of the following is a supply authority:\n(a) a written prescription;\n(b) a written requisition;\n(c) a purchase order;\n(d) a standing order;\n(e) a document that purports to be a document mentioned in\nparagraph (a), (b), (c) or (d).\nNote A purchase order and standing order must be in writing (see the\ndefinitions of these terms in the dictionary).\n","sortOrder":24},{"sectionNumber":"24","sectionType":"section","heading":"Meaning of possess, sell and supply—Act","content":"24 Meaning of possess, sell and supply—Act\npossess, for a regulated substance, includes the following:\n(a) receive or obtain possession of the substance;\n(b) have control over the disposition of the substance (whether with\nor without custody of the substance);\n(c) have joint possession of the substance.\nsell includes the following:\n(a) offer or expose for sale;\n\n(b) dispose of by any method for value (or offer or expose for\ndisposal by any method for value);\n(c) possess for sale or disposal for value.\nsupply—\n(a) includes the following:\n(i) sell (or offer or expose for sale);\n(ii) dispense;\nNote Dispense means supply on prescription (see dict).\n(iii) supply under a requisition or standing order;\n(iv) dispose of by any method for free (other than by\ndiscarding); but\n(b) does not include administer.\n\nChapter 4 Offences relating to regulated\nPart 4.1 Dealings with regulated\nsubstances—offences\n25 Meaning of declared substance—pt 4.1\ndeclared substance means—\n(a) a medicine; or\n(b) a dangerous poison; or\n(c) a prohibited substance; or\n(d) a schedule 10 substance; or\n(e) a low harm poison, or moderate harm poison, prescribed by\n26 Supplying declared substances\n(a) the person supplies a declared substance to someone else; and\n(b) the person is not authorised to supply the substance to the other\nNote Supply includes sell or offer to sell (see s 24).\n\n(a) the person supplies a declared substance to themself; and\n(b) the person is not authorised to supply the substance to themself.\n","sortOrder":25},{"sectionNumber":"27","sectionType":"section","heading":"Supplying declared substances on invalid supply","content":"27 Supplying declared substances on invalid supply\nauthorities—strict liability offences\n(a) the person is authorised to supply a declared substance on a\n(b) the person supplies the declared substance on a supply authority;\nand\n(c) 1 or more of the following apply in relation to the supply\n(i) all or part of the authority is illegible;\n(ii) the authority has been changed;\n(iii) the authority has been marked ‘cancelled’;\n(iv) for a supply authority for a declared substance that is a\ncontrolled medicine—the authority is issued more than\n6 months before the date the substance medicine is\nsupplied;\n(v) for a supply authority for a declared substance other than a\ncontrolled medicine—the authority is issued more than 1\nyear before the date the substance is supplied.\n\n(2) Subsection (1) (c) (i) and (ii) do not apply in relation to the supply of\na declared substance by a person if, before the supply, the person\nchecks the content of the supply authority with the person who issued\nthe authority (the issuer) and—\n(a) the supply is in accordance with the authority as confirmed by\nthe issuer; or\n(b) if the authority is a prescription—\n(i) the authority is changed by a pharmacist at the oral\ndirection of the issuer; and\n(ii) the pharmacist notes the change on the authority as\n(iii) the supply is in accordance with the authority as changed.\n(3) Subsection (1) does not apply to an employee or agent of a person\n(the principal) if the employee or agent supplies the declared\nsubstance at the direction of the principal.\n(4) To remove any doubt, subsection (3) does not affect the principal’s\nliability for the offence under section 171 (Acts and omissions of\nrepresentatives of individuals).\n(5) An offence against subsection (1) is a strict liability offence.\n","sortOrder":26},{"sectionNumber":"28","sectionType":"section","heading":"Supplying declared substances on invalid supply","content":"28 Supplying declared substances on invalid supply\nauthorities—recklessness\nA person (the supplier) commits an offence if—\n(a) a supply authority is issued by a person who is not authorised to\nissue the authority; and\n(b) the supplier supplies a declared substance on the supply\nauthority; and\n\n(c) the supplier is reckless about whether the supply authority is\nissued by someone who is not authorised to issue it.\n","sortOrder":27},{"sectionNumber":"29","sectionType":"section","heading":"Supplying declared substances on invalid supply","content":"29 Supplying declared substances on invalid supply\nauthorities—other offences\n(a) the person supplies a declared substance on a supply authority;\nand\n(b) 1 or more of the following apply in relation to the supply\n(i) the person knows the authority was obtained because of\nfalse information given to the person (the issuer) who\nissued the authority;\n(ii) the person could reasonably believe that the authority has\nbeen changed by someone other than the issuer;\n(iii) the person could reasonably believe that the authority is\nfalse in a material particular.\n(2) However, subsection (1) (b) (ii) does not apply to the supply of a\ndeclared substance by a person if—\n(a) before supplying the substance, the person checks whether the\nchange to the supply authority was made by the issuer; and\n(b) the issuer confirms the change.\n\n(3) Further, subsection (1) (b) (ii) does not apply to the supply of a\ndeclared substance on a prescription or requisition if—\n(a) before the substance is supplied by the person, the prescription\nor requisition is changed at the oral direction of the issuer; and\n(b) the person notes the change on the prescription or requisition as\nprescribed by regulation.\n","sortOrder":28},{"sectionNumber":"30","sectionType":"section","heading":"Cancellation etc of invalid supply authorities for declared","content":"30 Cancellation etc of invalid supply authorities for declared\nrelevant circumstance, in relation to a supply authority given to a\nperson to supply a declared substance, means—\n(a) all or part of the authority is illegible; or\n(b) all or part of the authority has been obliterated; or\n(c) 1 or more of the following apply in relation to the supply\n(i) the supply authority was issued by someone who was not\nauthorised to issue it;\n(ii) the person knows the authority was obtained because of\nfalse information given to the person (the issuer) who\nissued the authority;\n(iii) the person could reasonably believe that the authority has\nbeen changed by someone other than the issuer;\n(iv) the person could reasonably believe that the authority is\nfalse in a material particular;\n(v) the person could reasonably believe that the supply\nauthority is a forgery.\n\n(a) the person is authorised to supply a declared substance on a\n(b) the person is given a supply authority for the supply of the\n(c) a relevant circumstance applies in relation to the authority; and\n(d) the person does not cancel the authority as prescribed by\nNote For how long a cancelled supply authority must be kept, see s 47.\n","sortOrder":29},{"sectionNumber":"31","sectionType":"section","heading":"Supply of certain declared substances—information for","content":"31 Supply of certain declared substances—information for\nchief health officer\n(a) the person supplies any of the following on a supply authority:\n(i) a monitored medicine;\n(ii) a declared substance (other than a monitored medicine)\n(b) the person does not give the chief health officer the required\ninformation as prescribed by regulation.\n(a) the person supplies any of the following otherwise than on a\nsupply authority:\n(i) a monitored medicine;\n\n(ii) a declared substance (other than a monitored medicine)\n(b) the person does not give the chief health officer the required\ninformation as prescribed by regulation.\n(3) Strict liability applies to subsection (1) (b) and subsection (2) (b).\nrequired information means the information prescribed by\n","sortOrder":30},{"sectionNumber":"32","sectionType":"section","heading":"Information about invalid supply authorities for chief","content":"32 Information about invalid supply authorities for chief\nhealth officer\n(a) the person cancels a supply authority for a declared substance\nprescribed by regulation for section 30 (Cancellation etc of\ninvalid supply authorities for declared substances); and\n(b) the declared substance is—\n(i) a prescription only medicine; or\n(ii) a controlled medicine; or\n(iii) a dangerous poison; or\n(iv) another declared substance prescribed by regulation; and\n(c) either—\n(i) the person fails to tell the chief health officer and a police\nofficer about the authority and the reason for cancelling the\nauthority immediately after cancelling it; or\n\n(ii) not later than 24 hours after the relevant circumstance\nunder section 30 happens, the person fails to—\n(A) tell the chief health officer, in writing, about the\nreason; and\n(B) give the chief health officer a copy of the cancelled\nauthority.\n(a) the person supplies a declared substance on a supply authority;\nand\n(b) the declared substance is—\n(i) a prescription only medicine; or\n(ii) a controlled medicine; or\n(iii) a dangerous poison; or\n(iv) another declared substance prescribed by regulation; and\n(c) after the person supplies the substance the person becomes\naware of any of the following (the designated circumstance):\n(i) the supply authority was issued by someone who was not\nauthorised to issue it;\n(ii) the supply contravened a provision of—\n(A) section 27 (1) (c) (Supplying declared substances on\ninvalid supply authorities—strict liability offences);\nor\n(B) section 29 (1) (b) (Supplying declared substances on\ninvalid supply authorities—other offences); and\n\n(d) either—\n(i) the person fails to tell the chief health officer and a police\nofficer about the supply authority immediately after the\nperson becomes aware of the designated circumstance; or\n(ii) not later than 24 hours after the person becomes aware of\nthe designated circumstance, the person fails to—\n(A) tell the chief health officer, in writing, about the\n(B) give the chief health officer a copy of the authority.\n(3) A person must not be prosecuted for an offence under subsection (2)\ninvolving a contravention of section 27 (1) (c) or section 29 (1) (b)\nif—\n(a) at the time the person supplied the declared substance on the\nsupply authority the person believed on reasonable grounds that\nno designated circumstance applied in relation to the supply\nauthority; and\n(b) the person does not contravene subsection (2).\n\n","sortOrder":31},{"sectionNumber":"Div 4","sectionType":"division","heading":"1.3 Regulated substances—other","content":"Division 4.1.3 Regulated substances—other\ndealings\n","sortOrder":32},{"sectionNumber":"33","sectionType":"section","heading":"Manufacturing regulated substances","content":"33 Manufacturing regulated substances\n(a) the person manufactures a regulated substance; and\n(b) the person is not authorised to manufacture the substance.\n","sortOrder":33},{"sectionNumber":"34","sectionType":"section","heading":"Discarding declared etc substances","content":"34 Discarding declared etc substances\n(a) a regulation prescribes how a declared substance must be\ndiscarded; and\n(b) the person discards the substance; and\n(c) the person does not discard the substance as prescribed.\n(a) the person possesses a declared substance; and\n(b) the chief health officer gives the person a direction under\nsection 191 (Directions about dealings with regulated\nsubstances and therapeutic goods) in relation to the discarding\nof the substance; and\n(c) the person does not discard the substance as directed.\n\n(3) A person commits an offence if the person discards a declared\nsubstance in a way that—\n(b) is likely to cause damage to property or the environment.\nNote The Dangerous Substances Act 2004, Environment Protection Act 1997\nand Work Health and Safety Act 2011 may also apply to the discarding of\na regulated substance.\n(4) However, subsection (3) does not apply if the declared substance is\ndiscarded in accordance with—\n(a) a regulation about how the substance must be discarded; or\n(b) a direction by the chief health officer under section 191.\n(5) A person commits an offence if—\n(a) the person discards a low harm poison or moderate harm poison;\nand\n(b) the poison is not a declared substance; and\n(c) the discarding—\n(i) puts the health or safety of people at risk; or\n(ii) causes damage to property or the environment.\nNote The Dangerous Substances Act 2004, Environment Protection Act 1997\nand Work Health and Safety Act 2011 may also apply to the discarding of\na regulated substance.\n\n","sortOrder":34},{"sectionNumber":"35","sectionType":"section","heading":"Obtaining certain declared substances","content":"35 Obtaining certain declared substances\n(a) the person obtains a declared substance that is—\n(i) a pharmacy medicine, or pharmacist only medicine,\nprescribed by regulation; or\n(ii) a prescription only medicine; or\n(iii) a controlled medicine; or\n(iv) a dangerous poison; or\n(v) a prohibited substance; and\n(b) the person is not authorised to obtain the substance.\n(a) the person obtains a prescription only medicine; and\n(b) the person is not authorised to obtain the medicine.\n","sortOrder":35},{"sectionNumber":"36","sectionType":"section","heading":"Possessing certain declared substances","content":"36 Possessing certain declared substances\n(a) the person possesses a declared substance that is—\n(i) a pharmacy medicine, or pharmacist only medicine,\nprescribed by regulation; or\n(ii) a prescription only medicine; or\n(iii) a controlled medicine; or\n\n(iv) a dangerous poison; or\n(v) a prohibited substance; and\n(b) the person is not authorised to possess the substance.\n","sortOrder":36},{"sectionNumber":"37","sectionType":"section","heading":"Administering certain declared substances","content":"37 Administering certain declared substances\npharmacy medicine or pharmacist only medicine) to someone\nelse; and\n(b) the person is not authorised to administer the substance to the\nother person.\npharmacy medicine or pharmacist only medicine) to themself;\nand\n(b) the person is not authorised to administer the substance to\nthemself.\n(3) A person does not commit an offence under the Criminal Code,\nsection 45 (Complicity and common purpose) in relation to an\noffence committed by another person under subsection (1) or (2) of\nthis section only because the person supplies sterile injecting\nequipment to the other person for the purpose of preventing the spread\nof blood-borne disease.\n\n(4) A person commits an offence if—\npharmacy medicine or pharmacist only medicine) to an animal;\nand\n(b) the person is not authorised to administer the substance to the\nanimal.\n","sortOrder":37},{"sectionNumber":"38","sectionType":"section","heading":"Issuing purchase orders for declared substances","content":"38 Issuing purchase orders for declared substances\n(a) the person issues a purchase order for a declared substance; and\n(b) the person is not authorised to issue the purchase order for the\n(a) the person is authorised to issue a purchase order for a declared\n(b) the person issues a purchase order for the substance; and\n(c) the purchase order does not comply with the requirements\nprescribed by regulation.\n\n","sortOrder":38},{"sectionNumber":"39","sectionType":"section","heading":"Reporting loss and theft of certain regulated substances","content":"39 Reporting loss and theft of certain regulated substances\nreportable substance means—\n(a) a controlled medicine; or\n(b) a dangerous poison; or\n(c) a prohibited substance; or\n(d) a schedule 10 substance; or\n(e) another regulated substance prescribed by regulation.\n(a) the person is authorised to possess a reportable substance; and\n(b) the person possesses the substance; and\n(c) the substance is lost or the person suspects that the substance has\nbeen lost; and\n(d) the person fails to tell the chief health officer, in writing, about\nthe loss or suspected loss and how it happened as soon as\npracticable (but not later than 7 days) after the day the person\nbecomes aware of the loss or suspected loss.\n(a) the person is authorised to possess a reportable substance; and\n(b) the person possesses the substance; and\n(c) the substance is stolen or the person suspects that the substance\nhas been stolen; and\n\n(d) the person fails to tell the chief health officer and a police officer\nabout the theft or suspected theft—\n(i) orally immediately after the person becomes aware of the\ntheft or suspected theft; and\n(ii) in writing not later than 24 hours after the person becomes\naware of the theft or suspected theft.\n","sortOrder":39},{"sectionNumber":"40","sectionType":"section","heading":"Prescribing medicines","content":"40 Prescribing medicines\nfor someone else; and\n(b) the person is not authorised to prescribe the medicine for the\nother person.\nfor themself; and\n(b) the person is not authorised to prescribe the medicine for\nthemself.\nfor an animal; and\n\n(b) the person is not authorised to prescribe the medicine for the\nanimal.\n","sortOrder":40},{"sectionNumber":"41","sectionType":"section","heading":"Issuing requisitions for medicines","content":"41 Issuing requisitions for medicines\n(a) the person issues a requisition for a medicine (whether orally or\nin writing); and\n(b) the person is not authorised to issue the requisition.\n","sortOrder":41},{"sectionNumber":"42","sectionType":"section","heading":"Issuing standing orders for medicines","content":"42 Issuing standing orders for medicines\n(a) the person issues a standing order for a medicine; and\n(b) the person is not authorised to issue the standing order.\n\n","sortOrder":42},{"sectionNumber":"43","sectionType":"section","heading":"Medicines for animals not to be prescribed etc for human","content":"43 Medicines for animals not to be prescribed etc for human\nuse\n(a) the person prescribes a medicine for human use; and\n(c) the person is not authorised to prescribe the medicine for human\nuse.\n(a) the person supplies a medicine for human use; and\n(c) the person is not authorised to supply the medicine for human\nuse.\nNote Supply includes dispense (see s 24).\n(a) the person administers a medicine to themself or someone else;\nand\n\n(c) the person is not authorised to administer the medicine for\nhuman use.\n","sortOrder":43},{"sectionNumber":"44","sectionType":"section","heading":"Contravening authorisation conditions for regulated","content":"44 Contravening authorisation conditions for regulated\n(a) the person is authorised to deal with a regulated substance; and\n(c) the person is reckless about whether the dealing contravenes the\ncondition.\n(a) the person is authorised to deal with a regulated substance; and\n(c) the person contravenes the condition.\nNote 1 For examples of conditions that might be prescribed by regulation, see\ns 186.\nNote 2 A reference to an Act includes a reference to the statutory instruments\n\nDealings—other offences Division 4.1.4\n","sortOrder":44},{"sectionNumber":"45","sectionType":"section","heading":"Pretending to be authorised to deal with regulated","content":"45 Pretending to be authorised to deal with regulated\nsubstance\n(1) A person commits an offence if the person pretends to be authorised\nto deal with a regulated substance.\n(2) A person commits an offence if the person pretends to be authorised\nto deal with a regulated substance.\n\n","sortOrder":45},{"sectionNumber":"Part 4","sectionType":"part","heading":"2 Records for regulated","content":"Part 4.2 Records for regulated\nsubstances—offences\n","sortOrder":46},{"sectionNumber":"46","sectionType":"section","heading":"Accessibility of records","content":"46 Accessibility of records\n(a) the person is required under this Act to record something in\nrelation to a regulated substance; and\n(b) the person does not record the thing—\n(i) in writing; and\n(ii) in English; and\n(iii) in a way that is easily retrievable.\nNote 1 Written includes in electronic form (see dict).\nNote 2 A reference to an Act includes a reference to statutory instruments made\n\n","sortOrder":47},{"sectionNumber":"47","sectionType":"section","heading":"Keeping cancelled invalid supply authorities","content":"47 Keeping cancelled invalid supply authorities\n(a) the person cancels a supply authority under section 30\n(Cancellation etc of invalid supply authorities for declared\nsubstances); and\n(b) the person fails to ensure that the cancelled supply authority is\nkept for at least 2 years after the day the person cancels the\nsupply authority.\n(2) Subsection (1) does not apply to a person if—\n(a) the person is required under this Act to give the supply authority\nto the chief health officer or a police officer; or\n(b) either the chief health officer or a police officer requires the\nperson to give the supply authority to the chief health officer or\npolice officer.\n(3) An offence against subsection (1) is a strict liability offence.\n","sortOrder":48},{"sectionNumber":"48","sectionType":"section","heading":"Meaning of must keep register—div 4.2.2","content":"48 Meaning of must keep register—div 4.2.2\nFor this division, a person must keep a register for a regulated\nsubstance—\n(a) if the person is prescribed by regulation for the substance; or\n(b) if—\n(i) the person is a pharmacist who is responsible for the\nmanagement of a community pharmacy; and\n(ii) controlled medicines are kept at the pharmacy.\nNote Community pharmacy—see the dictionary.\n\n","sortOrder":49},{"sectionNumber":"49","sectionType":"section","heading":"Registers—not keeping","content":"49 Registers—not keeping\n(b) the person does not keep the register as prescribed by regulation.\n(b) the person does not keep the register as prescribed by regulation.\n","sortOrder":50},{"sectionNumber":"50","sectionType":"section","heading":"Registers—where to be kept","content":"50 Registers—where to be kept\n(b) a regulation prescribes a place to keep the register; and\n(c) the person fails to keep the register at the place prescribed.\n(b) a regulation prescribes a place to keep the register; and\n(c) the person fails to keep the register at the place prescribed.\n\n","sortOrder":51},{"sectionNumber":"51","sectionType":"section","heading":"Registers—duty to ensure entries made","content":"51 Registers—duty to ensure entries made\n(1) A person (the principal) who must keep a register for a regulated\nsubstance commits an offence if—\n(a) the principal, or an employee or agent of the principal, deals with\nthe regulated substance; and\n(b) the principal fails to ensure that the details prescribed by\nregulation for the dealing are entered in the register prescribed\nby regulation as soon as practicable (but not later than 24 hours)\nafter the dealing happens.\n(2) An offence against subsection (1) is a strict liability offence.\n","sortOrder":52},{"sectionNumber":"52","sectionType":"section","heading":"Registers—signing entries","content":"52 Registers—signing entries\n(a) the person makes an entry in a register for a regulated substance;\nand\n(b) the person fails to sign the entry as soon as practicable (but not\nlater than 24 hours) after the entry is made.\n","sortOrder":53},{"sectionNumber":"53","sectionType":"section","heading":"Registers—witnessing administration of medicines","content":"53 Registers—witnessing administration of medicines\n(a) a regulated substance is prescribed by regulation; and\n(b) the person is prescribed by regulation as a witness in relation to\nthe administration of the substance; and\n\n(c) the person witnesses the administration of the medicine; and\n(d) the administration of the medicine is entered in a register for the\nmedicine; and\n(e) the person fails to sign the entry in the register as witness as soon\nas practicable (but not later than 24 hours) after the entry is\nmade.\n","sortOrder":54},{"sectionNumber":"54","sectionType":"section","heading":"Registers—witnessing discarding","content":"54 Registers—witnessing discarding\n(a) a regulated substance is prescribed by regulation; and\n(b) the person is prescribed by regulation as a witness in relation to\nthe discarding of the substance; and\n(c) the person witnesses the discarding of the substance; and\n(d) the discarding of the substance is entered in the register for the\n(e) the person fails to sign the entry in the register as witness as soon\nas practicable (but not later than 24 hours) after the entry is\nmade.\n\n","sortOrder":55},{"sectionNumber":"55","sectionType":"section","heading":"Registers—changes etc to entries","content":"55 Registers—changes etc to entries\n(1) A person commits an offence if the person cancels, changes, deletes\nor obliterates an entry in a register for a regulated substance.\n(2) However, subsection (1) does not apply to a person if the person—\n(a) made the entry in the register; and\n(b) amends the entry as prescribed by regulation.\nNote It is an offence to produce a document in compliance with a territory law\nif the document is false or misleading in a material particular (see\nCriminal Code, s 339).\n","sortOrder":56},{"sectionNumber":"56","sectionType":"section","heading":"Registers—period to be kept","content":"56 Registers—period to be kept\n(b) the person fails to ensure that the register is kept for at least\n2 years after the day when the last entry is made in the register.\nNote For how long a register for a regulated substance kept electronically must\nbe kept, see the Electronic Transactions Act 2001, s 11 and this Act,\ns 187.\n","sortOrder":57},{"sectionNumber":"57","sectionType":"section","heading":"Registers—damage or loss","content":"57 Registers—damage or loss\n(b) the register is damaged in a material respect, stolen, lost or\ndestroyed; and\n\n(c) the person fails to tell the chief health officer, in writing, about\nthe damage, theft, loss or destruction as soon as practicable (but\nnot later than 7 days) after the day it happens.\n(b) the register is damaged in a material respect, stolen, lost or\ndestroyed; and\n(c) the person does not take an inventory as prescribed by regulation\nof each regulated substance in the person’s possession to which\nthe register related.\nNote Possess includes have control over disposition (see s 24).\n(3) This section does not apply to a register for a regulated substance if\nthe most recent entry in the register is made more than 2 years before\nthe day the register is damaged, stolen, lost or destroyed.\nmaterial respect—a register for a regulated substance is damaged in\na material respect if anything required to be entered in the register is\nmissing or cannot be easily read.\n\n","sortOrder":58},{"sectionNumber":"58","sectionType":"section","heading":"Transferring responsibility for community pharmacies—","content":"58 Transferring responsibility for community pharmacies—\nstocktake etc of controlled medicines\n(1) A pharmacist (the responsible pharmacist) who is responsible for the\nmanagement of a community pharmacy commits an offence if—\n(a) the pharmacist proposes to stop being responsible for the\npharmacy for a continuous period of longer than 14 days; and\n(b) before the pharmacist stops being responsible for the pharmacy,\nthe pharmacist fails to—\n(i) take a written inventory of each quantity of each form and\nstrength of a controlled medicine held in the pharmacy; and\n(ii) enter each of the quantities in the controlled medicines\nregister for the pharmacy; and\n(iii) sign and date each entry in the register.\nNote Community pharmacy and signs—see the dictionary.\n(2) A pharmacist commits an offence if—\n(a) the pharmacist intends to take responsibility for a community\npharmacy for a continuous period of more than 14 days; and\n(b) before taking responsibility for the pharmacy, the pharmacist\nfails to—\n(i) check the entries made in the controlled medicines register\nfor the pharmacy under subsection (1) (b) (ii); and\n(ii) for each of the entries in the register, indicate in writing\nwhether the pharmacist agrees that the entry is a correct\nrecord of the quantity of the form and strength of the\ncontrolled medicine held in the pharmacy; and\n\n(iii) sign and date each of the entries in the register.\n(3) The responsible pharmacist for a community pharmacy commits an\noffence if—\n(a) the pharmacist takes an inventory of controlled medicines held\nin the pharmacy; and\n(b) the quantity of a form and strength of a controlled medicine held\nat the pharmacy is not the quantity shown for the form and\nstrength of the medicine in the controlled medicines register for\nthe pharmacy; and\n(c) the pharmacist fails to take reasonable steps to resolve the\ndiscrepancy between—\n(i) the quantity of the form and strength of the controlled\nmedicine held at the pharmacy; and\n(ii) the quantity shown in the register.\n(4) The responsible pharmacist for a community pharmacy commits an\noffence if—\n(a) the pharmacist takes an inventory of controlled medicines held\nin the pharmacy; and\n(b) the quantity of a form and strength of a controlled medicine held\nat the pharmacy is not the quantity shown for the form and\nstrength of the medicine in the controlled medicines register for\nthe pharmacy; and\n\n(c) the pharmacist does not tell the chief health officer about the\ndiscrepancy—\n(i) orally immediately after checking the entries in the\ncontrolled medicines register; and\n(ii) in writing not later than 24 hours after finishing the check.\ncontrolled medicines register, for a community pharmacy, means a\nregister for controlled medicines that a pharmacist must keep for the\npharmacy under section 48 (Meaning of must keep register—\ndiv 4.2.2).\n\nPart 4.3 Regulated substances—other\noffences\n","sortOrder":59},{"sectionNumber":"59","sectionType":"section","heading":"Packaging of supplied regulated substances","content":"59 Packaging of supplied regulated substances\n(b) the person supplies the substance to someone else; and\n(c) the substance is not packaged—\n(ii) in accordance with an approval under section 193\n(Approval of non-standard packaging and labelling).\n(b) the person supplies the substance to someone else; and\n(c) the substance is not packaged—\n(ii) in accordance with an approval under section 193.\n(3) This section does not apply to a regulated substance that is supplied\nfor immediate administration to a person.\n(4) An offence against subsection (2) is a strict liability offence.\n\nPackaging and labelling—offences Division 4.3.1\n","sortOrder":60},{"sectionNumber":"60","sectionType":"section","heading":"Labelling of supplied regulated substances","content":"60 Labelling of supplied regulated substances\n(b) the person supplies a regulated substance to someone else; and\n(c) the substance is not labelled—\n(ii) in accordance with an approval under section 193\n(Approval of non-standard packaging and labelling).\n(b) the person supplies a regulated substance to someone else; and\n(c) the substance is not labelled—\n(ii) in accordance with an approval under section 193.\n(3) This section does not apply to a regulated substance that is supplied\nfor immediate administration to a person.\n(4) An offence against subsection (2) is a strict liability offence.\n\n","sortOrder":61},{"sectionNumber":"61","sectionType":"section","heading":"Storing declared substances","content":"61 Storing declared substances\n(a) the person is authorised to possess a declared substance; and\n(b) the person is prescribed by regulation in relation to the\n(c) the person fails to store the substance as prescribed by\nDivision 4.3.3 Containers—offences\n","sortOrder":62},{"sectionNumber":"62","sectionType":"section","heading":"Permanently named containers—use for other regulated","content":"62 Permanently named containers—use for other regulated\n(a) the person uses a container for a regulated substance; and\n(b) the container is permanently marked with the name of a different\nregulated substance.\n\nRepresentations and advertisements—offences Division 4.3.4\n","sortOrder":63},{"sectionNumber":"63","sectionType":"section","heading":"Certain containers not to be used for human-use","content":"63 Certain containers not to be used for human-use\n(a) the person supplies a human-use substance in a container; and\n(b) the container is of a kind prescribed by regulation.\n(2) For this section, each of the following substances is a human-use\nsubstance:\n(a) food;\n(b) a drink;\n(c) a condiment.\nDivision 4.3.4 Representations and\nadvertisements—offences\n","sortOrder":64},{"sectionNumber":"64","sectionType":"section","heading":"False statements to obtain certain regulated substances","content":"64 False statements to obtain certain regulated substances\netc\nreportable substance—see section 39.\n(a) the person makes a statement to a person (the authorised\nperson) who is authorised to administer or supply a reportable\nNote Supply includes dispense on prescription (see s 24).\n(b) the statement is false or misleading; and\n\n(c) the person knows the statement—\nmisleading; and\n(d) the person makes the statement for the purpose of obtaining the\nsubstance from the authorised person.\n(a) the person makes a statement to a person (the authorised\nperson) who is authorised to issue a prescription or purchase\norder for a reportable substance; and\n(b) the statement is false or misleading; and\n(c) the person is reckless about whether the statement—\nmisleading; and\n(d) the person makes the statement for the purpose of obtaining the\nprescription or purchase order from the authorised person.\n(4) A person commits an offence if—\n(a) the person states a name or home address to—\n(i) a person (the authorised person) authorised to dispense a\nreportable substance; or\n(ii) an employee or agent of an authorised person in the course\nof the employee’s or agent’s employment or agency; and\n\nRepresentations and advertisements—offences Division 4.3.4\n(b) the statement—\nmisleading.\n(5) An offence against subsection (4) is a strict liability offence.\n(6) Subsections (2), (3) and (4) do not apply to the making of a statement\nif the statement is not false or misleading in a material particular.\n(7) Subsections (2), (3) and (4) do not apply to the omission of something\nfrom a statement if the omission does not make the statement not false\nor misleading in a material particular.\n","sortOrder":65},{"sectionNumber":"65","sectionType":"section","heading":"Falsely representing substance is regulated","content":"65 Falsely representing substance is regulated\n(1) A person (the supplier) commits an offence if—\n(a) the supplier supplies a substance as a particular regulated\nsubstance (the purported substance); and\n(b) the supplier knows that the substance is not the purported\n(2) A person (the supplier) commits an offence if—\n(a) the supplier supplies a substance as a particular regulated\nsubstance (the purported substance); and\n(b) the supplier is reckless about whether the substance is the\npurported substance.\n\n","sortOrder":66},{"sectionNumber":"66","sectionType":"section","heading":"Advertising controlled medicines and prohibited","content":"66 Advertising controlled medicines and prohibited\n(a) the person publishes an advertisement; and\n(b) the advertisement promotes or encourages the use of a\ncontrolled medicine or prohibited substance.\n(a) the person publishes an advertisement; and\n(b) the advertisement indicates that someone is willing or authorised\nto supply a controlled medicine or prohibited substance.\n(3) This section does not apply to—\n(a) an advertisement for a controlled medicine in a publication\npublished primarily for dentists, doctors, pharmacists or\nveterinary practitioners; or\n(b) an advertisement by a pharmacist prescribed by regulation; or\n(c) an advertisement prescribed by regulation.\nadvertisement means writing, sound or a picture, symbol, light or\nother visible device, object or sign (or a combination of 2 or more of\nthese) that a reasonable person would consider publicises, or\notherwise promotes, the purchase or use of a controlled medicine or\nprohibited substance.\n\nVending machines—offences Division 4.3.5\n","sortOrder":67},{"sectionNumber":"67","sectionType":"section","heading":"Meaning of vending machine—div 4.3.5","content":"67 Meaning of vending machine—div 4.3.5\nIn this division:\nvending machine means a machine or device from which regulated\nsubstances can be obtained, including by 1 or more of the following:\n(a) electronic funds transfer;\n(b) inserting money, a token or another object.\nExamples of other objects—par (b)\n1 credit card\n2 debit card\n3 key\n","sortOrder":68},{"sectionNumber":"68","sectionType":"section","heading":"Vending machines—use for supply of regulated","content":"68 Vending machines—use for supply of regulated\n(a) the person is the occupier of premises; and\n(b) a vending machine is installed on the premises; and\n(c) the vending machine is used, or available for use, for the supply\nof a regulated substance by a person other than the occupier or\nan employee or agent of the occupier.\n(2) Subsection (1) does not apply if the vending machine was placed on\nthe premises without the occupier’s consent.\n\n","sortOrder":69},{"sectionNumber":"69","sectionType":"section","heading":"Vending machines—use for supply of unscheduled","content":"69 Vending machines—use for supply of unscheduled\nmedicines\nmanufacturer’s pack, of an unscheduled medicine, means a primary\npack of the medicine that has been packaged and labelled by the\nmedicine’s manufacturer as prescribed by regulation.\nunscheduled medicine means a substance mentioned in the\nmedicines and poisons standard, schedules 2, 3, 4 or 8 if none of the\nschedules apply to the substance because of an exception in the\nstandard.\nAspirin is mentioned in several schedules but in small packages is an unscheduled\nmedicine.\n(a) the person is the occupier of premises; and\n(b) a vending machine is installed on the premises; and\n(c) the vending machine is used, or available for use, for the supply\nof an unscheduled medicine.\n(3) Subsection (2) does not apply if the vending machine was placed on\nthe premises without the occupier’s consent.\n(4) Also, subsection (2) does not apply if—\n(a) the unscheduled medicine is supplied in a manufacturer’s pack\ncontaining not more than 2 adult doses of the medicine; and\n(b) the medicine was packed in the manufacturer’s pack by the\nmanufacturer of the medicine; and\n\nPaints—offences Division 4.3.6\n(c) the vending machine is presented and located in a way that\nmakes unsupervised access by children unlikely.\n","sortOrder":70},{"sectionNumber":"70","sectionType":"section","heading":"Manufacture, supply and use of paints containing white","content":"70 Manufacture, supply and use of paints containing white\nlead\n(a) the person manufactures a paint containing basic lead carbonate\n(white lead); and\n(b) the paint is not manufactured as prescribed by regulation.\n(a) the person supplies a paint containing basic lead carbonate\n(white lead); and\n(b) the paint is not supplied as prescribed by regulation.\n(a) the person uses a paint containing basic lead carbonate (white\nlead); and\n(b) the paint is not used as prescribed by regulation.\n\n","sortOrder":71},{"sectionNumber":"71","sectionType":"section","heading":"Manufacture, supply and use of paints for certain","content":"71 Manufacture, supply and use of paints for certain\npurposes\n(1) A person commits an offence if the person manufactures, supplies or\nuses a first group paint as prescribed by regulation.\nMaximum penalty: 40 penalty units.\n(2) A person commits an offence if the person manufactures, supplies or\nuses a second group paint as prescribed by regulation.\n(3) A person commits an offence if the person manufactures, supplies or\nuses a paint or tinter as prescribed by regulation.\n","sortOrder":72},{"sectionNumber":"72","sectionType":"section","heading":"Manufacture, supply and use of paints for toys","content":"72 Manufacture, supply and use of paints for toys\n(a) the person manufactures, supplies or uses a paint for application\nto toys; and\n(b) the paint is not prescribed by regulation.\n","sortOrder":73},{"sectionNumber":"73","sectionType":"section","heading":"Manufacture, supply and use of paints containing","content":"73 Manufacture, supply and use of paints containing\npesticides\n(a) the person manufactures, supplies or uses a paint containing a\npesticide; and\n\nPaints—offences Division 4.3.6\n(b) the pesticide is not prescribed by regulation.\n\nChapter 5 Offences relating to regulated therapeutic goods\nChapter 5 Offences relating to regulated\n74 Supplying regulated therapeutic goods\n(a) the person supplies a regulated therapeutic good to someone\nelse; and\n(b) the person is not authorised to supply the good to the other\nNote 1 Supply includes sell or offer to sell (see s 24).\nNote 2 Regulated therapeutic good—see s 14.\n(2) Subsection (1) does not apply if the person supplies sterile injecting\nequipment to someone else for the purpose of preventing the spread\nof blood-borne disease.\n(a) the person supplies a regulated therapeutic good to themself; and\n(b) the person is not authorised to supply the good to themself.\n(4) A person does not commit an offence under the Criminal Code,\nsection 45 (Complicity and common purpose) in relation to an\noffence committed by another person under subsection (3) of this\nsection only because the person supplies sterile injecting equipment\nto the other person for the purpose of preventing the spread of blood-\nborne disease.\n\nOffences relating to regulated therapeutic goods Chapter 5\n","sortOrder":74},{"sectionNumber":"75","sectionType":"section","heading":"Contravening authorisation conditions for regulated","content":"75 Contravening authorisation conditions for regulated\n(a) the person is authorised to deal with a regulated therapeutic\ngood; and\n(c) the person contravenes the condition.\n","sortOrder":75},{"sectionNumber":"76","sectionType":"section","heading":"Pretending to be authorised to deal with regulated","content":"76 Pretending to be authorised to deal with regulated\nA person commits an offence if the person pretends to be authorised\nto deal with a regulated therapeutic good.\n","sortOrder":76},{"sectionNumber":"77","sectionType":"section","heading":"Falsely representing thing is regulated","content":"77 Falsely representing thing is regulated\n(1) A person (the supplier) commits an offence if—\n(a) the supplier supplies a thing as a particular regulated therapeutic\ngood (the purported therapeutic good); and\n(b) the supplier knows that the thing is not the purported therapeutic\n\n","sortOrder":77},{"sectionNumber":"Part 5","sectionType":"part","heading":"Offences relating to regulated therapeutic goods","content":"Chapter 5 Offences relating to regulated therapeutic goods\n(2) A person (the supplier) commits an offence if—\n(a) the supplier supplies a thing as a particular regulated therapeutic\ngood (the purported therapeutic good); and\n(b) the supplier is reckless about whether the thing is the purported\ntherapeutic good.\n\n","sortOrder":78},{"sectionNumber":"Part 6","sectionType":"part","heading":"Licences for regulated","content":"Chapter 6 Licences for regulated\nsubstances and regulated\n","sortOrder":79},{"sectionNumber":"78","sectionType":"section","heading":"Meaning of licence etc—ch 6","content":"78 Meaning of licence etc—ch 6\nlicence means a licence that authorises the licence-holder to deal with\na regulated substance or regulated therapeutic good.\n(2) A regulation may prescribe the licences that may be issued under this\nAct.\n(3) To remove any doubt, the chief health officer may issue a licence to\na person to deal with a regulated substance or regulated therapeutic\ngood even if the licence is not prescribed by regulation for\nsubsection (2).\n","sortOrder":80},{"sectionNumber":"79","sectionType":"section","heading":"Meaning of close associate—ch 6","content":"79 Meaning of close associate—ch 6\nclose associate—a person is a close associate of someone (the related\nperson) if—\n(a) the person holds or will hold an executive position (however\ndescribed) in the related person’s business; or\n(b) the chief health officer is satisfied that the person is or will be\nable to exercise a significant influence in relation to the conduct\nof the related person’s business because the person holds or will\nhold a financial interest, or is entitled to exercise a relevant\npower, in the business.\nNote Business—see the dictionary.\n\nexecutive position—a position (however described) in the related\nperson’s business is an executive position if the holder of the position\nis concerned with, or takes part in, the management of the business.\nexercise a power includes exercise the power on behalf of someone\nelse.\nfinancial interest, in a business, means—\n(a) a share in the capital of the business; or\n(b) an entitlement to receive income derived from the business,\nhowever the entitlement arises.\nhold a position includes hold the position on behalf of someone else.\npower means a power exercisable—\n(a) by voting or otherwise; and\n(b) alone or with others.\nrelevant power, in a business, means a power—\n(a) to take part in a directorial, managerial or executive decision for\nthe business; or\n(b) to elect or appoint a person as an executive officer in the\nbusiness.\n","sortOrder":81},{"sectionNumber":"80","sectionType":"section","heading":"Meaning of influential person for corporation—ch 6","content":"80 Meaning of influential person for corporation—ch 6\ninfluential person, for a corporation, means any of the following:\n(a) an executive officer of the corporation;\n(b) a person who may exercise a relevant power in relation to the\ncorporation;\n(c) a related corporation;\n\n(d) an executive officer of a related corporation.\nrelated corporation means a related body corporate under the\nCorporations Act.\nrelevant power, for a corporation, means a power—\n(a) to take part in a directorial, managerial or executive decision for\nthe corporation; or\n(b) to elect or appoint a person as an executive officer in the\ncorporation; or\n(c) to exercise a significant influence in relation to the conduct of\nthe corporation.\n","sortOrder":82},{"sectionNumber":"81","sectionType":"section","heading":"Suitability of individuals for licences","content":"81 Suitability of individuals for licences\n(1) In deciding whether an individual is a suitable person to hold a\nlicence, the chief health officer must have regard to the following:\n(a) the knowledge, experience and training of the individual in\nrelation to the regulated substances or regulated therapeutic\ngoods to which the licence relates;\n(b) the dealings with regulated substances or regulated therapeutic\ngoods to which the licence relates;\n(c) whether the individual or a close associate of the individual, or\na corporation of which the individual was at the relevant time an\nexecutive officer, has—\n(i) supplied information or a document in relation to this Act\nthat is false or misleading in a material particular; or\n(ii) contravened this Act or a corresponding law, whether or\nnot the individual, associate or corporation has been\nconvicted or found guilty of an offence for the\ncontravention; or\n\n(iii) failed to comply with a condition of a licence under this\nAct or a licence (however described) under a\ncorresponding law, whether or not the individual, associate\nor corporation has been convicted or found guilty of an\noffence for the failure;\n(d) anything prescribed by regulation.\nNote A reference to an Act includes a reference to statutory instruments made\n(2) However, an individual is not a suitable person to hold a licence if—\n(a) the individual, a close associate of the individual, or a\ncorporation of which the individual was at the relevant time an\nexecutive officer, has been convicted or found guilty of any of\nthe following in the 5-year period before the day the application\nfor the licence is made:\n(i) an offence against this Act;\n(ii) an offence in Australia or elsewhere in relation to a\nregulated substance or regulated therapeutic good; or\n(b) the individual, or a close associate of the individual, is, or was\nat any time in the 5-year period before the day the application\nfor the licence is made, bankrupt or personally insolvent; or\nNote Bankrupt or personally insolvent—see the Legislation Act,\ndictionary, pt 1.\n(c) at any time in the 5-year period before the day the application\nfor the licence is made, the individual, or a close associate of the\nindividual, was involved in the management of a corporation\nwhen—\n(i) the corporation became the subject of a winding-up order;\nor\n(ii) an administrator was appointed for the corporation; or\n\n(d) a circumstance prescribed by regulation applies in relation to the\nindividual or a close associate of the individual.\n(3) Despite subsection (2), the chief health officer may decide that an\nindividual is a suitable person to hold a licence if satisfied that—\n(a) the individual’s dealings with regulated substances or regulated\ntherapeutic goods authorised, or to be authorised, by the licence\nwould not be inconsistent with the objects of this Act if the chief\nhealth officer decided that the individual is a suitable person;\nand\n(b) it is otherwise in the public interest that the individual be treated\nas a suitable person.\n","sortOrder":83},{"sectionNumber":"82","sectionType":"section","heading":"Suitability of corporations for licences","content":"82 Suitability of corporations for licences\n(1) For this Act, a corporation is a suitable person for a licence if—\n(a) each influential person of the corporation is a suitable person to\nhold a licence; and\n(b) the corporation is not the subject of a winding-up order, and has\nnot been the subject of a winding-up order in the 5-year period\nbefore the day the application for the licence is made; and\n(c) an administrator has not been appointed for the corporation in\nthe 5-year period before the day the application for the licence\nis made.\n(2) However, if a corporation is not a suitable person for a licence under\nsubsection (1), the chief health officer may decide that the corporation\nis a suitable person to hold a licence if satisfied that—\n(a) the corporation’s dealings with regulated substances or\nregulated therapeutic goods authorised, or to be authorised, by\nthe licence would not be inconsistent with the objects of this Act\nif the chief health officer decided that the corporation is a\nsuitable person; and\n\n(b) it is otherwise in the public interest that the corporation be\ntreated as a suitable person.\n","sortOrder":84},{"sectionNumber":"83","sectionType":"section","heading":"Power to ask for information etc from applicants and","content":"83 Power to ask for information etc from applicants and\nothers\napplication means—\n(a) an application for a licence; or\n(b) an application to amend a licence.\ndesignated person, in relation to an applicant or licence means—\n(a) the applicant or licence-holder; or\n(b) a close associate of, or influential person for, the applicant or\nlicence-holder.\n(2) The chief health officer may, in writing, ask a designated person in\nrelation to an application or licence to do 1 or more of the following:\n(a) give the chief health officer stated information relevant to the\napplication or licence;\n(b) produce for the chief health officer’s inspection a stated\ndocument relevant to the application or licence;\n(c) allow the chief health officer to examine, copy or take extracts\nfrom a stated document relevant to the application or licence\n(including a document produced for the chief health officer’s\ninspection under paragraph (b));\n(d) verify, by a statement or otherwise, information given or a\ndocument produced to the chief health officer;\n(e) authorise a stated person to do anything mentioned in\nparagraphs (a) to (d);\n\n(f) give the chief health officer the authorities and consents that the\nchief health officer asks for to allow the chief health officer to\nobtain from other people information (including financial and\nother confidential information) that is—\n(i) about the designated person; and\n(ii) relevant to—\n(A) the consideration of the application; or\n(B) a consideration of whether the licence-holder\ncontinues to be a suitable person for a licence.\nExamples—par (a)\n1 The notice may ask the designated person to give information by preparing a\ndocument in a stated way or by completing a document provided by the chief\nhealth officer.\n","sortOrder":85},{"sectionNumber":"2","sectionType":"section","heading":"The notice may ask the designated person to give the chief health officer","content":"2 The notice may ask the designated person to give the chief health officer\ninformation about a close associate because of a change of the kind to which\nsection 93 (Licensee to keep chief health officer informed) applies.\nExample—par (b)\na statement supplied by a police officer about the applicant’s criminal history\n(if any)\nExample—par (c)\nThe notice may ask the applicant to authorise the applicant’s accountant, or a former\nclose associate, to give the chief health officer stated information or documents\nabout the applicant.\n(3) A request under subsection (2) must state a reasonable time within\nwhich the request must be complied with.\n\n","sortOrder":86},{"sectionNumber":"84","sectionType":"section","heading":"Applications for licences","content":"84 Applications for licences\n(1) A person may apply to the chief health officer for a licence.\n(2) The applicant must give the chief health officer a written statement\n(a change statement) if, before the application is decided, a change\nhappens in relation to—\n(a) something mentioned in the application; or\n(b) a document, or something mentioned in a document, that\naccompanied the application.\n(3) A change statement must—\n(a) set out the details of the change; and\n(b) ask the chief health officer to amend the application to include\nthe change; and\n(c) be signed by the applicant.\n","sortOrder":87},{"sectionNumber":"85","sectionType":"section","heading":"Decision on applications for licences","content":"85 Decision on applications for licences\n(1) On application under section 84, the chief health officer must issue\nthe licence to the applicant if satisfied that—\n(a) no restriction on the issue of the licence prescribed by regulation\napplies in relation to the applicant; and\n(b) the applicant is a suitable person to hold the licence; and\n(c) the applicant can comply with this Act in relation to the\nregulated substances or regulated therapeutic goods to which the\napplication relates.\n(2) The chief health officer must refuse to issue the licence if not satisfied\nabout the matters mentioned in subsection (1).\n\n(3) However, the chief health officer need not decide the application if\nthe chief health officer has asked for something under section 83 and\nthe request has not been complied with.\n","sortOrder":88},{"sectionNumber":"86","sectionType":"section","heading":"Term of licences","content":"86 Term of licences\n(1) A licence is issued for the period stated in the licence.\n(2) A licence must not be issued for longer than 3 years, or any shorter\nperiod prescribed by regulation.\n","sortOrder":89},{"sectionNumber":"87","sectionType":"section","heading":"Licences not transferable","content":"87 Licences not transferable\nA licence is not transferable.\n","sortOrder":90},{"sectionNumber":"88","sectionType":"section","heading":"Form of licences","content":"88 Form of licences\n(1) A licence must be in writing and include the following information:\n(a) what licence it is or the dealings with regulated substances or\nregulated therapeutic goods authorised by the licence;\n(b) the regulated substances or regulated therapeutic goods to which\nthe licence relates;\n(c) the full name of the licence-holder;\n(d) the licence-holder’s ABN (if any);\n(e) if the licence-holder is a corporation—the corporation’s ACN;\n(f) if applicable, the location of the premises where the\nlicence-holder is authorised to deal with a regulated substance\nor regulated therapeutic good under the licence;\n(g) if applicable, the name of each individual who is to supervise\nthe dealings authorised under the licence;\n(h) any conditions included in the licence by the chief health officer;\nNote See s 90 to s 92 for conditions included in a licence by the chief\nhealth officer.\n\n(i) a unique identifying number;\n(j) when the term of the licence ends;\n(k) any other information prescribed by regulation.\n(2) For this Act, the conditions mentioned in subsection (1) (h) may be\nincluded in a separate document and, if they are, the separate\ndocument forms part of the licence.\n","sortOrder":91},{"sectionNumber":"89","sectionType":"section","heading":"Statutory licence conditions","content":"89 Statutory licence conditions\nA licence is subject to the following conditions:\n(a) the licence-holder must comply with any written request by the\nchief health officer under section 83 (Power to ask for\ninformation etc from applicants and others) in relation to the\namendment of the licence;\n(b) if section 93 (Licensee to keep chief health officer informed)\napplies in relation to the licence-holder, the licence-holder must\ncomply with the section;\n(c) a condition prescribed by regulation.\n","sortOrder":92},{"sectionNumber":"90","sectionType":"section","heading":"Other licence conditions","content":"90 Other licence conditions\n(1) A licence is subject to any condition the chief health officer includes\nin the licence when giving the licence or at any other time.\n(2) For subsection (1), the chief health officer may include a condition in\na licence to ensure that regulated substances and regulated therapeutic\ngoods are properly dealt with under the licence, including, for\nexample—\n(a) a condition about—\n(i) the supervision of the dealings; and\n\n(ii) the security of regulated substances and regulated\ntherapeutic goods and of premises where regulated\nsubstances and regulated therapeutic goods are stored; and\n(iii) the keeping of records about the dealings; and\n(b) for a regulated substance—a condition recommended by the\nmedicines and poisons standard for dealing with the regulated\n","sortOrder":93},{"sectionNumber":"91","sectionType":"section","heading":"Amending licence on chief health officer’s initiative","content":"91 Amending licence on chief health officer’s initiative\n(1) The chief health officer may, by written notice (an amendment\nnotice) given to a licence-holder, amend the licence to change a\nlicence condition.\n(2) However, the chief health officer may amend the licence to change a\nlicence condition only if—\n(a) the chief health officer has given the licence-holder written\nnotice (a proposal notice) of the proposed amendment; and\n(b) the notice states that written comments on the proposal may be\nmade to the chief health officer before the end of a stated period\nof at least 14 days after the day the proposal notice is given to\nthe licence-holder; and\n(c) after the end of the stated period, the chief health officer has\nconsidered any comments made in accordance with the notice.\n(3) The amendment takes effect on the day the amendment notice is given\nto the licence-holder or any later day stated in the notice.\nchange, for a licence condition, means—\n(a) amend an existing licence condition; or\n(b) impose a new licence condition; or\n(c) remove an existing licence condition.\n\ncondition does not include a condition mentioned in section 89\n(Statutory licence conditions).\n","sortOrder":94},{"sectionNumber":"92","sectionType":"section","heading":"Amending licence on application by licence-holder","content":"92 Amending licence on application by licence-holder\n(1) A licence-holder may apply to the chief health officer to amend the\nlicence (including by changing a licence condition).\n(2) In deciding whether to amend the licence, the chief health officer may\nconsider anything that may be considered under section 85 (Decision\non applications for licences) in relation to an application for a licence.\n(3) If the chief health officer receives an application under subsection (1),\nthe chief health officer must—\n(a) amend the licence in accordance with the application; or\n(b) amend the licence in terms different to the application; or\n(c) refuse to amend the licence.\n(4) However, the chief health officer need not decide the application if\nthe chief health officer has asked for something under section 83\n(Power to ask for information etc from applicants and others) and the\nrequest has not been complied with.\nchange, for a licence condition—see section 91 (4).\ncondition—see section 91 (4).\n","sortOrder":95},{"sectionNumber":"93","sectionType":"section","heading":"Licensee to keep chief health officer informed","content":"93 Licensee to keep chief health officer informed\n(1) This section applies if a licence-holder believes that there will be a\nchange (the anticipated change) to anything stated in—\n(a) the licence; or\n(b) the application for the licence; or\n\n(c) an application to amend the licence.\nNote Failure to comply with this section contravenes a condition of the licence\n(see s 89 (b)).\n(2) The licence-holder must—\n(a) give the chief health officer written notice of the anticipated\nchange not later than 7 days before the day the change is\nexpected to happen; and\n(b) if the change affects the information shown on the licence—\napply under section 92 to amend the licence to take account of\nthe change.\nExamples of changes\n1 a change of the person who, under the licence that authorises the supply by\nwholesale of a controlled medicine, must supervise the supply of the medicine\n2 a change in a close associate of, or influential person for, the licence-holder\n3 a structural change in premises relevant to dealing with a regulated substance\n","sortOrder":96},{"sectionNumber":"94","sectionType":"section","heading":"Returning licences for amendment","content":"94 Returning licences for amendment\n(1) A licence-holder commits an offence if—\n(a) the licence-holder’s licence is amended under section 91\n(Amending licence on chief health officer’s initiative) or\nsection 92 (Amending licence on application by licence-holder);\nand\n(b) the licence-holder fails to return the licence to the chief health\nofficer as soon as practicable (but not later than 7 days) after the\nday the licence-holder is told about the chief health officer’s\naction or decision.\nMaximum penalty: 20 penalty units.\n\n","sortOrder":97},{"sectionNumber":"95","sectionType":"section","heading":"Replacing licences","content":"95 Replacing licences\n(1) The chief health officer may issue a replacement licence to a\nlicence-holder if satisfied that the licence-holder’s original licence\nhas been lost, stolen or destroyed.\n(2) For subsection (1), the chief health officer may require the\nlicence-holder to give the chief health officer a statement verifying\nthat the original licence has been lost, stolen or destroyed.\n\nLicences—other provisions Part 6.3\nPart 6.3 Licences—other provisions\n","sortOrder":98},{"sectionNumber":"96","sectionType":"section","heading":"Contravening licence conditions","content":"96 Contravening licence conditions\n(a) the person is a licence-holder; and\n(b) the licence is subject to a condition; and\n(c) the person is reckless about whether an act or omission by the\nperson contravenes the condition.\n(2) A licence-holder commits an offence if the licence-holder\ncontravenes a condition of the licence.\n","sortOrder":99},{"sectionNumber":"97","sectionType":"section","heading":"Surrendering licences","content":"97 Surrendering licences\n(1) A licence-holder may surrender the licence by giving written notice\nof the surrender to the chief health officer.\n(2) The licence-holder must, with the notice—\n(a) return the licence to the chief health officer; or\n(b) if the licence has been lost, stolen or destroyed—give the chief\nhealth officer a statement verifying that the licence has been lost,\nstolen or destroyed.\n\n","sortOrder":100},{"sectionNumber":"97A","sectionType":"section","heading":"Meaning of monitored medicine","content":"97A Meaning of monitored medicine\nmonitored medicine means—\n(a) a controlled medicine; or\n(b) a medicine declared by the Minister to be a monitored medicine.\n(2) For the definition of monitored medicine, paragraph (b), the Minister\nmay declare a medicine to be a monitored medicine if satisfied that\nthe declaration is consistent with the purposes of the monitored\nmedicines database.\n(3) A declaration under this section is a disallowable instrument.\n","sortOrder":101},{"sectionNumber":"97B","sectionType":"section","heading":"Definitions—ch 6A","content":"97B Definitions—ch 6A\nanother jurisdiction—\n(a) means the Commonwealth or a State; and\n(b) includes an entity established under a law of the Commonwealth\nor a State.\nNote State includes the Northern Territory (see Legislation Act, dict, pt 1).\napproved data source entity means an entity engaged by another\njurisdiction to collect, access, store or otherwise deal with\ninformation about monitored medicines.\nmonitored medicines database—see section 97D.\n\nrelevant health practitioner means a health practitioner authorised\nby regulation to prescribe or supply a monitored medicine.\nrequired information, about the supply of a monitored medicine—\nsee section 31 (4).\n","sortOrder":102},{"sectionNumber":"97C","sectionType":"section","heading":"Monitored medicines database—purposes","content":"97C Monitored medicines database—purposes\n(1) The main purpose of the monitored medicines database is to promote\nand protect public health and safety by ensuring that information is\navailable to—\n(a) monitor and evaluate the supply of monitored medicines to a\nperson; and\n(b) support the exercise of the chief health officer’s functions.\n(2) A regulation may prescribe additional purposes for the monitored\nmedicines database.\n","sortOrder":103},{"sectionNumber":"97D","sectionType":"section","heading":"Monitored medicines database—scope","content":"97D Monitored medicines database—scope\n(1) The chief health officer may keep a database (the monitored\nmedicines database) to record information relating to monitored\nmedicines.\n(2) The monitored medicines database may be kept in any form,\nincluding electronically, that the chief health officer decides.\n(3) The chief health officer may—\n(a) correct an error or omission in the monitored medicines\n(b) change information included in the database to keep the\ndatabase accurate and up-to-date.\n(4) The monitored medicines database may include the following:\n(a) required information about the supply of a monitored medicine\nunder a supply authority;\n\n(b) information about the approval to prescribe a monitored\nmedicine;\n(c) information from another jurisdiction in relation to the supply or\nprescription of a monitored medicine in the other jurisdiction;\n(d) information in relation to a monitored medicine from an\napproved data source entity;\n(e) any other information prescribed by regulation.\n","sortOrder":104},{"sectionNumber":"97E","sectionType":"section","heading":"Monitored medicines database—chief health officer","content":"97E Monitored medicines database—chief health officer\nfunctions\nThe chief health officer has the following functions in relation to the\nmonitored medicines database:\n(a) to collect and store required information about monitored\nmedicines;\n(b) to enter into an arrangement with another jurisdiction or an\napproved data source entity to—\n(i) collect and store information for the database; and\n(ii) allow access to information on the database; and\n(iii) allow the use and disclosure of information on the\ndatabase;\n(c) to access and use the database to—\n(i) monitor, promote and protect public health and safety; and\n(ii) facilitate research into the provision of healthcare; and\n(iii) administer, develop and operate the database; and\n(iv) ensure compliance with the Act;\n(d) to allow access to, and the use and disclosure of, information on\nthe database by a person mentioned in section 97F or\nsection 97G (Monitored medicines database—access authority);\n\n(e) any other function under this Act or another territory law.\nNote A provision of a law that gives an entity (including a person) a function\nalso gives the entity powers necessary and convenient to exercise the\nfunction (see Legislation Act, s 196 and dict, pt 1, def entity).\n","sortOrder":105},{"sectionNumber":"97F","sectionType":"section","heading":"Monitored medicines database—access and use by","content":"97F Monitored medicines database—access and use by\nrelevant health practitioners\n(1) A relevant health practitioner may access and use the monitored\nmedicines database for 1 or more of the following purposes:\n(a) to inform decisions in relation to the prescription or supply of a\nmonitored medicine to a person under the relevant health\npractitioner’s care;\n(b) to inform decisions in relation to the treatment or care of a\nperson under the relevant health practitioner’s care;\n(c) to disclose information about a person under the relevant health\npractitioner’s care to that person;\n(d) to disclose information about a person under the relevant health\npractitioner’s care to another health practitioner involved in the\nperson’s treatment or care;\n(e) a purpose prescribed by regulation.\n(2) The chief health officer must make the monitored medicines database\navailable to a relevant health practitioner at no cost.\n","sortOrder":106},{"sectionNumber":"97G","sectionType":"section","heading":"Monitored medicines database—access authority","content":"97G Monitored medicines database—access authority\n(1) A person, other than a relevant health practitioner, may apply to the\nchief health officer for authorisation to access and use the monitored\nmedicines database (an access authority).\n\n(2) The chief health officer may issue the access authority only if\nsatisfied that giving the access authority to the person is—\n(a) consistent with a purpose of the monitored medicines database;\nand\n(b) otherwise in the public interest.\n(3) An access authority must—\n(a) be in writing; and\n(b) include the following information:\n(i) the name of the person to whom the authority is issued;\n(ii) the purpose for which the authority is issued;\n(iii) any conditions applying to the authority;\n(iv) the expiry date of the authority.\n","sortOrder":107},{"sectionNumber":"97H","sectionType":"section","heading":"Monitored medicines database—offences","content":"97H Monitored medicines database—offences\n(b) the access is not authorised under this chapter.\nMaximum penalty: 30 penalty units.\n(b) the person uses the accessed information; and\n(c) the use is not authorised under this chapter.\n\n(b) the person discloses the accessed information to someone else;\nand\n(c) the disclosure is not authorised under this chapter.\n(4) Strict liability applies to subsections (1) (a), (2) (a) and (3) (a).\ndisclose, in relation to information accessed from the monitored\nmedicines database, includes—\n(a) communicate the information; or\n(b) publish the information.\nuse, in relation to information accessed from the monitored medicines\ndatabase, includes make a record of the information.\n\n","sortOrder":108},{"sectionNumber":"98","sectionType":"section","heading":"Definitions—pt 7.1","content":"98 Definitions—pt 7.1\nconnected—a thing is connected with an offence if—\n(a) the offence has been committed in relation to it; or\n(b) it will provide evidence of the commission of the offence; or\n(c) it was used, is being used, or is intended to be used, to commit\nthe offence.\noccupier, of premises, includes—\n(a) a person believed on reasonable grounds to be an occupier of the\npremises; and\n(b) a person apparently in charge of the premises.\noffence includes an offence that there are reasonable grounds for\nbelieving has been, is being, or will be, committed.\n","sortOrder":109},{"sectionNumber":"99","sectionType":"section","heading":"Meaning of medicines and poisons inspector—Act","content":"99 Meaning of medicines and poisons inspector—Act\nmedicines and poisons inspector means—\n(a) a police officer; or\n(b) a person appointed under section 100.\n\nMedicines and poisons inspectors Division 7.1.2\n","sortOrder":110},{"sectionNumber":"Div 7","sectionType":"division","heading":"1.2 Medicines and poisons inspectors","content":"Division 7.1.2 Medicines and poisons inspectors\n","sortOrder":111},{"sectionNumber":"100","sectionType":"section","heading":"Appointment of medicines and poisons inspectors","content":"100 Appointment of medicines and poisons inspectors\nThe chief health officer may appoint a public servant to be a\nmedicines and poisons inspector for this Act.\nNote 1 For the making of appointments (including acting appointments), see the\nLegislation Act, pt 19.3.\nNote 2 In particular, a person may be appointed for a particular provision of a\nlaw (see Legislation Act, s 7 (3)) and an appointment may be made by\nnaming a person or nominating the occupant of a position (see Legislation\nAct, s 207).\n","sortOrder":112},{"sectionNumber":"101","sectionType":"section","heading":"Identity cards","content":"101 Identity cards\n(1) The chief health officer must give a medicines and poisons inspector\n(other than a police officer) an identity card stating the person’s name\nand that the person is a medicines and poisons inspector.\n(2) The identity card must show—\n(a) a recent photograph of the person; and\n(b) the card’s date of issue and expiry; and\n(c) anything else prescribed by regulation.\n(a) the person stops being a medicines and poisons inspector; and\n(b) the person does not return the person’s identity card to the chief\nhealth officer as soon as practicable (but not later than 7 days)\nafter the day the person stops being a medicines and poisons\ninspector.\nMaximum penalty: 1 penalty unit.\n(4) An offence against this section is a strict liability offence.\n\nDivision 7.1.3 Powers of medicines and poisons\ninspectors\n","sortOrder":113},{"sectionNumber":"102","sectionType":"section","heading":"Power to enter premises","content":"102 Power to enter premises\n(1) For this Act, a medicines and poisons inspector may—\n(a) at any reasonable time, enter premises that the public is entitled\nto use or that are open to the public (whether or not on payment);\nor\n(b) at any time, enter premises with the occupier’s consent; or\n(c) enter premises in accordance with a search warrant; or\n(d) at any time, enter premises if the inspector believes on\nreasonable grounds that the circumstances are so serious and\nurgent that immediate entry to the premises without the\nauthority of a search warrant is necessary.\n(2) However, subsection (1) (a) does not authorise entry into a part of\npremises that is being used only for residential purposes.\n(3) A medicines and poisons inspector may, without the consent of the\noccupier of premises, enter land around the premises to ask for\nconsent to enter the premises.\n(4) To remove any doubt, a medicines and poisons inspector may enter\npremises under subsection (1) without payment of an entry fee or\nother charge.\nat any reasonable time includes at any time when the public is\nentitled to use the premises, or when the premises are open to or used\nby the public (whether or not on payment).\n\n","sortOrder":114},{"sectionNumber":"103","sectionType":"section","heading":"Production of identity card","content":"103 Production of identity card\nA medicines and poisons inspector must not remain at premises\nentered under this part if the inspector does not produce their identity\ncard when asked by the occupier.\n","sortOrder":115},{"sectionNumber":"104","sectionType":"section","heading":"Consent to entry","content":"104 Consent to entry\n(1) When seeking the consent of an occupier of premises to enter the\npremises under section 102 (1) (b), a medicines and poisons inspector\nmust—\n(a) produce their identity card; and\n(b) tell the occupier—\n(i) the purpose of the entry; and\n(ii) that anything found and seized under this part may be used\nin evidence in court; and\n(iii) that consent may be refused.\n(2) If the occupier consents, the medicines and poisons inspector must\nask the occupier to sign a written acknowledgment\n(an acknowledgment of consent)—\n(a) that the occupier was told—\n(i) the purpose of the entry; and\n(ii) that anything found and seized under this part may be used\nin evidence in court; and\n(iii) that consent may be refused; and\n(b) that the occupier consented to the entry; and\n(c) stating the time and date when consent was given.\n(3) If the occupier signs an acknowledgment of consent, the medicines\nand poisons inspector must immediately give a copy to the occupier.\n\n(4) A court must find that the occupier did not consent to entry to the\npremises by the medicines and poisons inspector under this division\nif—\n(a) the question arises in a proceeding in the court whether the\noccupier consented to the entry; and\n(b) an acknowledgment of consent is not produced in evidence; and\n(c) it is not proved that the occupier consented to the entry.\n","sortOrder":116},{"sectionNumber":"105","sectionType":"section","heading":"General powers on entry to premises","content":"105 General powers on entry to premises\n(1) A medicines and poisons inspector who enters premises under this\npart may, for this Act, do 1 or more of the following in relation to the\npremises or anything on the premises:\n(a) inspect or examine;\n(b) examine and copy, or take extracts from, documents relating to\na regulated substance or regulated therapeutic good;\n(c) examine and copy, or take extracts from, any packaging,\nlabelling or advertising material;\n(d) take measurements or conduct tests;\n(e) take samples;\n(f) subject to part 7.2 (Taking and analysis of samples of\nsubstances), take for analysis samples of anything else\n(including any substance) at the premises;\n(g) open (or require to be opened) any container or package that the\ninspector believes on reasonable grounds contains a regulated\nsubstance or regulated therapeutic good;\n(h) take photographs, films, or audio, video or other recordings;\n\n(i) require the occupier, or anyone at the premises, to give\ninformation, answer questions, or produce documents or\nanything else, reasonably needed to exercise the inspector’s\nfunctions under this Act.\nNote The Legislation Act, s 170 and s 171 deal with the application of\nthe privilege against self-incrimination and client legal privilege.\n(2) A person must take all reasonable steps to comply with a requirement\nmade of the person under subsection (1) (g) or (i).\n","sortOrder":117},{"sectionNumber":"106","sectionType":"section","heading":"Power to seize things","content":"106 Power to seize things\n(1) A medicines and poisons inspector who enters premises under this\npart with the occupier’s consent may seize anything at the premises\nif—\n(a) the inspector is satisfied on reasonable grounds that the thing is\nconnected with an offence against this Act; and\n(b) seizure of the thing is consistent with the purpose of the entry\ntold to the occupier when seeking the occupier’s consent.\n(2) A medicines and poisons inspector who enters premises under a\nwarrant under this part may seize anything at the premises that the\ninspector is authorised to seize under the warrant.\n(3) A medicines and poisons inspector who enters premises under this\npart (whether with the occupier’s consent, under a warrant or\notherwise) may seize anything at the premises if satisfied on\nreasonable grounds that—\n(a) the thing is connected with an offence against this Act; and\n(b) the seizure is necessary to prevent the thing from being—\n(i) concealed, lost or destroyed; or\n(ii) used to commit, continue or repeat the offence.\n\n(4) Also, a medicines and poisons inspector who enters premises under\nthis part (whether with the occupier’s consent or otherwise) may seize\nanything at the premises if satisfied on reasonable grounds that the\nthing—\n(b) may cause damage to property or the environment.\n(5) The powers of a medicines and poisons inspector under\nsubsections (3) and (4) are additional to any powers of the inspector\nunder subsection (1) or any other territory law.\n(6) Having seized a thing, a medicines and poisons inspector may—\n(a) remove the thing from the premises where it was seized (the\nplace of seizure) to another place; or\n(b) leave the thing at the place of seizure but restrict access to it.\n(7) A person commits an offence if—\n(a) the person interferes with a seized thing, or anything containing\na seized thing, to which access has been restricted under\nsubsection (6); and\n(b) the person does not have a medicines and poisons inspector’s\napproval to interfere with the thing.\n(8) An offence against this section is a strict liability offence.\n","sortOrder":118},{"sectionNumber":"107","sectionType":"section","heading":"Power to destroy unsafe things","content":"107 Power to destroy unsafe things\n(1) This section applies to anything inspected or seized under this part by\na medicines and poisons inspector if the inspector is satisfied on\nreasonable grounds that the thing—\n(b) is likely to cause damage to property or the environment.\n\n(2) The medicines and poisons inspector may direct an occupier of the\npremises where the thing is to destroy or otherwise dispose of the\nthing.\n(3) The direction may state 1 or more of the following:\n(a) how the thing must be destroyed or otherwise disposed of;\n(b) how the thing must be kept until it is destroyed or otherwise\ndisposed of;\n(c) the period within which the thing must be destroyed or otherwise\ndisposed of.\n(4) A person given a direction under subsection (2) commits an offence\nif the person contravenes a direction given to the person under\nsubsection (2).\nMaximum penalty: 100 penalty units.\n(5) Alternatively, if the thing has been seized under this part, the\nmedicines and poisons inspector may destroy or otherwise dispose of\nthe thing.\n(6) Costs incurred by the Territory in relation to the disposal of a thing\nunder subsection (5) are a debt owing to the Territory by, and are\nrecoverable together and separately from, the following people:\n(a) the person who owned the thing;\n(b) each person in charge of the premises where the thing was.\n(7) An offence against this section is a strict liability offence.\n\n","sortOrder":119},{"sectionNumber":"108","sectionType":"section","heading":"Power to require name and address","content":"108 Power to require name and address\n(1) A medicines and poisons inspector may require a person to state the\nperson’s name and home address if the inspector believes on\nreasonable grounds that the person is committing or has just\ncommitted an offence against this Act.\n(2) The medicines and poisons inspector must tell the person the reason\nfor the requirement and, as soon as practicable, record the reason.\n(3) The person may ask the medicines and poisons inspector to produce\nthe inspector’s identity card for inspection by the person.\n(4) A person must comply with a requirement under subsection (1) if the\nmedicines and poisons inspector—\n(a) tells the person the reason for the requirement; and\n(b) complies with any request made by the person under\nsubsection (3).\nMaximum penalty: 10 penalty units.\n","sortOrder":120},{"sectionNumber":"109","sectionType":"section","heading":"Warrants generally","content":"109 Warrants generally\n(1) A medicines and poisons inspector may apply to a magistrate for a\nwarrant to enter premises.\n(2) The application must be sworn and state the grounds on which the\nwarrant is sought.\n(3) The magistrate may refuse to consider the application until the\nmedicines and poisons inspector gives the magistrate all the\ninformation the magistrate requires about the application in the way\nthe magistrate requires.\n\n(4) The magistrate may issue a warrant only if satisfied there are\nreasonable grounds for suspecting—\n(a) there is a particular thing or activity connected with an offence\nagainst this Act; and\n(b) the thing or activity is, or is being engaged in, at the premises,\nor may be, or may be engaged in, at the premises within the next\n14 days.\nNote At premises includes in or on the premises (see dict).\n(5) The warrant must state—\n(a) that a medicines and poisons inspector may, with any necessary\nassistance and force, enter the premises and exercise the\ninspector’s powers under this part; and\n(b) the offence for which the warrant is issued; and\n(c) the things that may be seized under the warrant; and\n(d) the hours when the premises may be entered; and\n(e) the date, within 14 days after the day of the warrant’s issue, that\nthe warrant ends.\n(6) In this section:\nconnected—an activity is connected with an offence if—\n(a) the offence has been committed by engaging or not engaging in\nit; or\n(b) it will provide evidence of the commission of the offence.\n\n","sortOrder":121},{"sectionNumber":"110","sectionType":"section","heading":"Warrants—application made other than in person","content":"110 Warrants—application made other than in person\n(1) A medicines and poisons inspector may apply for a warrant by phone,\nfax, radio or other form of communication if the inspector considers\nit necessary because of—\n(a) urgent circumstances; or\n(b) other special circumstances.\n(2) Before applying for the warrant, the medicines and poisons inspector\nmust prepare an application stating the grounds on which the warrant\nis sought.\n(3) The medicines and poisons inspector may apply for the warrant\nbefore the application is sworn.\n(4) After issuing the warrant, the magistrate must immediately provide a\nwritten copy to the medicines and poisons inspector if it is practicable\nto do so.\n(5) If it is not practicable to provide a written copy to the medicines and\npoisons inspector—\n(a) the magistrate must—\n(i) tell the inspector what the terms of the warrant are; and\n(ii) tell the inspector the date and time the warrant was issued;\nand\n(b) the inspector must complete a form of warrant (the warrant\nform) and write on it—\n(i) the magistrate’s name; and\n(ii) the date and time the magistrate issued the warrant; and\n(iii) the warrant’s terms.\n(6) The written copy of the warrant, or the warrant form properly\ncompleted by the medicines and poisons inspector, authorises the\nentry and exercise of the inspector’s powers under this part.\n\n(7) The medicines and poisons inspector must, at the first reasonable\nopportunity, send to the magistrate—\n(a) the sworn application; and\n(b) if the inspector completed a warrant form—the completed\nwarrant form.\n(8) On receiving the documents, the magistrate must attach them to the\nwarrant.\n(9) A court must find that a power exercised by a medicines and poisons\ninspector was not authorised by a warrant under this section if—\n(a) the question arises in a proceeding before the court whether the\nexercise of power was authorised by a warrant; and\n(b) the warrant is not produced in evidence; and\n(c) it is not proved that the exercise of power was authorised by a\nwarrant under this section.\n","sortOrder":122},{"sectionNumber":"111","sectionType":"section","heading":"Search warrants—announcement before entry","content":"111 Search warrants—announcement before entry\n(1) A medicines and poisons inspector must, before anyone enters\npremises under a search warrant—\n(a) announce that the inspector is authorised to enter the premises;\nand\n(b) give anyone at the premises an opportunity to allow entry to the\npremises; and\n(c) if an occupier of the premises, or someone else who apparently\nrepresents the occupier, is present at the premises—identify\nthemself to the person.\n\n(2) The medicines and poisons inspector is not required to comply with\nsubsection (1) if the inspector believes on reasonable grounds that\nimmediate entry to the premises is required to ensure—\n(a) the safety of anyone (including the inspector or any person\nassisting); or\n(b) that the effective execution of the warrant is not frustrated.\n","sortOrder":123},{"sectionNumber":"112","sectionType":"section","heading":"Details of search warrant to be given to occupier etc","content":"112 Details of search warrant to be given to occupier etc\nIf an occupier of premises, or someone else who apparently represents\nthe occupier, is present at the premises while a search warrant is being\nexecuted, the medicines and poisons inspector or a person assisting\nmust make available to the person—\n(a) a copy of the warrant; and\n(b) a document setting out the rights and obligations of the person.\n","sortOrder":124},{"sectionNumber":"113","sectionType":"section","heading":"Occupier entitled to be present during search etc","content":"113 Occupier entitled to be present during search etc\n(1) If an occupier of premises, or someone else who apparently represents\nthe occupier, is present at the premises while a search warrant is being\nexecuted, the occupier or the other person is entitled to observe the\nsearch being conducted.\n(2) However, the person is not entitled to observe the search if—\n(a) to do so would impede the search; or\n(b) the person is under arrest, and allowing the person to observe\nthe search being conducted would interfere with the objectives\nof the search.\n(3) This section does not prevent 2 or more areas of the premises being\nsearched at the same time.\n\n","sortOrder":125},{"sectionNumber":"114","sectionType":"section","heading":"Moving things to another place for examination or","content":"114 Moving things to another place for examination or\nprocessing\n(1) A thing found at premises entered under a search warrant may be\nmoved to another place for examination or processing to decide\nwhether it may be seized under the warrant if—\n(a) both of the following apply:\n(i) there are reasonable grounds for believing that the thing is\nor contains something to which the warrant relates;\n(ii) it is significantly more practicable to do so having regard\nto the timeliness and cost of examining or processing the\nthing at another place and the availability of expert\nassistance; or\n(b) the occupier of the premises agrees in writing.\n(2) The thing may be moved to another place for examination or\nprocessing for not longer than 72 hours.\n(3) A medicines and poisons inspector may apply to a magistrate for an\nextension of time if the inspector believes on reasonable grounds that\nthe thing cannot be examined or processed within 72 hours.\n(4) The medicines and poisons inspector must give notice of the\napplication to the occupier of the premises, and the occupier is\nentitled to be heard on the application.\n(5) If a thing is moved to another place under this section, the medicines\nand poisons inspector must, if practicable—\n(a) tell the occupier of the premises the address of the place where,\nand time when, the examination or processing will be carried\nout; and\n(b) allow the occupier or the occupier’s representative to be present\nduring the examination or processing.\n\n(6) The provisions of this part relating to the issue of search warrants\napply, with any necessary changes, to the giving of an extension\nunder this section.\n","sortOrder":126},{"sectionNumber":"115","sectionType":"section","heading":"Use of electronic equipment at premises","content":"115 Use of electronic equipment at premises\n(1) A medicines and poisons inspector or a person assisting may operate\nelectronic equipment at premises entered under a search warrant to\naccess data (including data not held at the premises) if the inspector\nor person believes on reasonable grounds that—\n(a) the data might be something to which the warrant relates; and\n(b) the equipment can be operated without damaging the data.\n(2) If the medicines and poisons inspector or person assisting believes on\nreasonable grounds that any data accessed by operating the electronic\nequipment might be something to which the warrant relates, the\ninspector or person may—\n(a) copy the data to a data storage device brought to the premises;\nor\n(b) if the occupier of the premises agrees in writing—copy the data\nto a data storage device at the premises.\n(3) The medicines and poisons inspector or person assisting may take the\ndevice from the premises.\n(4) The medicines and poisons inspector or person assisting may do the\nfollowing things if the inspector or person finds that anything (the\nmaterial) to which the warrant relates is accessible using the\nequipment:\n(a) seize the equipment and any data storage device;\n(b) if the material can, by using facilities at the premises, be put in\ndocumentary form—operate the facilities to put the material in\ndocumentary form and seize the documents produced.\n\n(5) A medicines and poisons inspector may seize equipment under\nsubsection (4) (a) only if—\n(a) it is not practicable to copy the data as mentioned in\nsubsection (2) or to put the material in documentary form as\nmentioned in subsection (4) (b); or\n(b) possession of the equipment by the occupier of the premises or\nsomeone else could be an offence.\n","sortOrder":127},{"sectionNumber":"116","sectionType":"section","heading":"Person with knowledge of computer to assist access etc","content":"116 Person with knowledge of computer to assist access etc\n(1) A medicines and poisons inspector may apply to a magistrate for an\norder requiring a stated person to provide any information or\nassistance that is reasonably necessary to allow the inspector or a\nperson assisting to do 1 or more of the following:\n(a) access data held in or accessible from a computer that is at the\npremises;\n(b) copy the data to a data storage device;\n(c) convert the data into documentary form.\n(2) The magistrate may make an order if satisfied that—\n(a) there are reasonable grounds for suspecting that something to\nwhich the warrant relates is accessible from the computer; and\n(b) the stated person is—\n(i) reasonably suspected of possessing, or having under the\nperson’s control, something to which the warrant relates;\nor\n(ii) the owner or lessee of the computer; or\n(iii) an employee or agent of the owner or lessee of the\ncomputer; and\n\n(c) the stated person has knowledge of—\n(i) the computer or a computer network of which the computer\nforms a part; or\n(ii) measures applied to protect data held in or accessible from\nthe computer.\n(3) A person commits an offence if the person contravenes an order under\nthis section.\n(4) The provisions of this part relating to the issue of search warrants\napply, with any necessary changes, to the making of an order under\nthis section.\n","sortOrder":128},{"sectionNumber":"117","sectionType":"section","heading":"Securing electronic equipment","content":"117 Securing electronic equipment\n(1) This section applies if the medicines and poisons inspector or a person\nassisting believes on reasonable grounds that—\n(a) something (the material) to which the warrant relates may be\naccessible by operating electronic equipment at the premises;\nand\n(b) expert assistance is required to operate the equipment; and\n(c) the material may be destroyed, altered or otherwise interfered\nwith if the inspector or person does not take action.\n(2) The medicines and poisons inspector or person assisting may do\nwhatever is necessary to secure the equipment, whether by locking it\nup, placing a guard or otherwise.\n\n(3) The medicines and poisons inspector or a person assisting must give\nwritten notice to an occupier of the premises of—\n(a) the inspector’s or person’s intention to secure the equipment;\nand\n(b) the fact that the equipment may be secured for up to 24 hours.\n(4) The equipment may be secured until the earlier of the following\nevents happens:\n(a) the end of the 24-hour period;\n(b) the equipment is operated by the expert.\n(5) If the medicines and poisons inspector or a person assisting believes\non reasonable grounds that the expert assistance will not be available\nwithin the 24-hour period, the inspector or person may apply to a\nmagistrate to extend the period.\n(6) The medicines and poisons inspector or a person assisting must tell\nan occupier of the premises of the intention to apply for an extension,\nand the occupier is entitled to be heard on the application.\n(7) The provisions of this part relating to the issue of search warrants\napply, with any necessary changes, to the giving of an extension\nunder this section.\n\n","sortOrder":129},{"sectionNumber":"118","sectionType":"section","heading":"Copies of seized things to be provided","content":"118 Copies of seized things to be provided\n(a) an occupier of premises, or someone else who apparently\nrepresents the occupier, is present at the premises while a search\nwarrant is executed; and\n(b) the medicines and poisons inspector seizes—\n(i) a document, film, computer file or something else that can\nbe readily copied; or\n(ii) a data storage device containing information that can be\nreadily copied.\n(2) The occupier or other person may ask the medicines and poisons\ninspector to give the person a copy of the thing or information.\n(3) The medicines and poisons inspector must give the person the copy\nas soon as practicable after the seizure.\n(4) However, the medicines and poisons inspector is not required to give\nthe copy if—\n(a) the thing was seized under section 115 (Use of electronic\nequipment at premises); or\n(b) possession of the thing or information by an occupier of the\npremises or someone else would be an offence.\n\n","sortOrder":130},{"sectionNumber":"119","sectionType":"section","heading":"Receipt for things seized","content":"119 Receipt for things seized\n(1) As soon as practicable after a medicines and poisons inspector seizes\na thing under this part, the inspector must give a receipt for it to the\nperson from whom it was seized.\n(2) If, for any reason, it is not practicable to comply with subsection (1),\nthe medicines and poisons inspector must leave the receipt, secured\nconspicuously, at the place of seizure under section 106 (Power to\nseize things).\n(3) A receipt under this section must include the following:\n(a) a description of the thing seized;\n(b) an explanation of why the thing was seized;\n(c) the medicines and poisons inspector’s name, and how to contact\nthe inspector;\n(d) if the thing is moved from the premises where it is seized—\nwhere the thing is to be taken.\n","sortOrder":131},{"sectionNumber":"120","sectionType":"section","heading":"Access to things seized","content":"120 Access to things seized\n(1) A person who would, apart from the seizure, be entitled to inspect a\nthing seized under this part may—\n(a) inspect it; and\n(b) if it is a document—take extracts from it or make copies of it.\n(2) This section does not apply to—\n(a) a thing seized under section 106 (4) (which is about the seizure\nof a thing that poses a risk to the health or safety of people or of\ndamage to property or the environment); or\n\n(b) a thing or information if possession of it by the person otherwise\nentitled to inspect it would be an offence.\n","sortOrder":132},{"sectionNumber":"121","sectionType":"section","heading":"Return of things seized","content":"121 Return of things seized\n(1) A thing seized under this part must be returned to its owner, or\nreasonable compensation must be paid by the Territory to the owner\nfor the loss of the thing, if—\n(a) an infringement notice for an offence relating to the thing is not\nserved on the owner within 90 days after the day of seizure and\na prosecution for an offence relating to the thing—\n(i) is not started within the 90-day period; or\n(ii) is started within the 90-day period but the court does not\nfind the offence proved; or\n(b) an infringement notice for an offence relating to the thing is\nserved on the owner within 90 days after the day of seizure, the\ninfringement notice is withdrawn and a prosecution for an\noffence relating to the thing—\n(i) is not started within the 90-day period; or\n(ii) is started within the 90-day period but the court does not\nfind the offence proved; or\n(c) an infringement notice for an offence relating to the thing is\nserved on the owner and not withdrawn within 90 days after the\nday of seizure, liability for the offence is disputed in accordance\nwith the Magistrates Court Act 1930, section 132 (Disputing\nliability for infringement notice offence) and an information—\n(i) is not laid in the Magistrates Court against the person for\nthe offence within 60 days after the day notice is given\nunder section 132 that liability is disputed; or\n\n(ii) is laid in the Magistrates Court against the person for the\noffence within the 60-day period, but the Magistrates Court\ndoes not find the offence proved.\n(2) However, this section does not apply—\n(a) to a thing seized under section 106 (4) (which is about the\nseizure of things that pose a risk to the health or safety of people\nor of damage to property or the environment); or\n(b) to a thing if the chief health officer believes on reasonable\ngrounds that the only practical use of the thing in relation to the\npremises where it was seized would be an offence against this\nAct or another territory law; or\n(c) to a thing if possession of it by its owner would be an offence.\nNote See also section 125 (Forfeiture of seized things).\n","sortOrder":133},{"sectionNumber":"122","sectionType":"section","heading":"Application for order disallowing seizure","content":"122 Application for order disallowing seizure\n(1) A person claiming to be entitled to anything seized under this part\nmay apply to the Magistrates Court within 10 days after the day of\nthe seizure for an order disallowing the seizure.\n(2) However, this section does not apply to a thing seized under\nsection 106 (4) (which is about the seizure of things that pose a risk\nto the health or safety of people or of damage to property or the\nenvironment).\n(3) The application may be heard only if the applicant has served a copy\nof the application on the chief health officer.\n(4) The chief health officer is entitled to appear as respondent at the\nhearing of the application.\n\n","sortOrder":134},{"sectionNumber":"123","sectionType":"section","heading":"Order for return of seized thing","content":"123 Order for return of seized thing\n(1) This section applies if a person claiming to be entitled to anything\nseized under this part applies to the Magistrates Court under\nsection 122 for an order disallowing the seizure.\n(2) The Magistrates Court must make an order disallowing the seizure if\nsatisfied that—\n(a) the applicant would, apart from the seizure, be entitled to the\nreturn of the seized thing; and\n(b) the thing is not connected with an offence against this Act; and\n(c) possession of the thing by the person would not be an offence.\n(3) The Magistrates Court may also make an order disallowing the\nseizure if satisfied there are exceptional circumstances justifying the\nmaking of the order.\n(4) If the Magistrates Court makes an order disallowing the seizure, the\ncourt may make 1 or more of the following ancillary orders:\n(a) an order directing the chief health officer to return the thing to\nthe applicant or someone else that appears to be entitled to it;\n(b) if the thing cannot be returned or has depreciated in value\nbecause of the seizure—an order directing the Territory to pay\nreasonable compensation;\n(c) an order about the payment of costs in relation to the application.\n\n","sortOrder":135},{"sectionNumber":"124","sectionType":"section","heading":"Adjournment pending hearing of other proceedings","content":"124 Adjournment pending hearing of other proceedings\n(1) This section applies to the hearing of an application under section 122\n(Application for order disallowing seizure).\n(2) If it appears to the Magistrates Court that the seized thing is required\nto be produced in evidence in a pending proceeding in relation to an\noffence against a territory law, the court may, on the application of\nthe chief health officer or its own initiative, adjourn the hearing until\nthe end of the pending proceeding.\n","sortOrder":136},{"sectionNumber":"125","sectionType":"section","heading":"Forfeiture of seized things","content":"125 Forfeiture of seized things\n(a) anything seized under this part has not been returned under\nsection 121 (Return of things seized); and\n(b) an application for disallowance of the seizure under section 122\n(Application for order disallowing seizure)—\n(i) has not been made within 10 days after the day of seizure;\nor\n(ii) has been made within the 10-day period, but the\napplication has been refused or has been withdrawn before\na decision in relation to the application had been made.\n(2) If this section applies to the seized thing—\n(a) it is forfeited to the Territory; and\n(b) it may be sold, destroyed or otherwise disposed of as the chief\nhealth officer directs.\n\n","sortOrder":137},{"sectionNumber":"126","sectionType":"section","heading":"Return of forfeited things","content":"126 Return of forfeited things\n(1) This section applies to something forfeited under section 125 that has\nnot been disposed of in a way that would prevent its return.\n(2) If the chief health officer becomes satisfied that there has been no\noffence against this Act with which the thing is connected, the chief\nhealth officer must, as soon as practicable, return the thing to the\nperson from whom it was seized or someone else who appears to the\nchief health officer to be entitled to it.\n(3) On its return, any proprietary and other interests in the thing that\nexisted immediately before its forfeiture are restored.\n","sortOrder":138},{"sectionNumber":"127","sectionType":"section","heading":"Cost of disposal of forfeited things","content":"127 Cost of disposal of forfeited things\n(a) a person is convicted, or found guilty, of an offence against this\nAct in relation to something forfeited to the Territory under this\npart; and\n(b) the thing is connected with an offence against this Act; and\n(c) the person was the owner of the thing immediately before its\nforfeiture.\nNote Found guilty—see the Legislation Act, dict, pt 1.\n(2) If this section applies, costs incurred by or on behalf of the Territory\nin relation to the lawful disposal of the thing (including storage costs)\nare a debt owing to the Territory by the person.\n\nMedicines and poisons inspectors—other provisions Division 7.1.6\nDivision 7.1.6 Medicines and poisons inspectors—\nother provisions\n","sortOrder":139},{"sectionNumber":"128","sectionType":"section","heading":"Disposal etc of things obtained otherwise than under","content":"128 Disposal etc of things obtained otherwise than under\npt 7.1\n(1) This section applies if the chief health officer comes into possession\nof a regulated substance or regulated therapeutic good otherwise than\nunder this part.\n(2) The chief health officer may dispose of the regulated substance or\nregulated therapeutic good as prescribed by regulation.\n","sortOrder":140},{"sectionNumber":"129","sectionType":"section","heading":"Damage etc to be minimised","content":"129 Damage etc to be minimised\n(1) In the exercise, or purported exercise, of a function under this part, a\nmedicines and poisons inspector must take all reasonable steps to\nensure that the inspector, and any person assisting the inspector,\ncauses as little inconvenience, detriment and damage as practicable.\n(2) If a medicines and poisons inspector, or a person assisting a medicines\nand poisons inspector, damages anything in the exercise or purported\nexercise of a function under this part, the inspector must give written\nnotice of the particulars of the damage to the person the inspector\nbelieves on reasonable grounds is the owner of the thing.\n(3) If the damage happens at premises entered under this part in the\nabsence of the occupier, the notice may be given by leaving it, secured\nconspicuously, at the premises.\n\nDivision 7.1.6 Medicines and poisons inspectors—other provisions\n","sortOrder":141},{"sectionNumber":"130","sectionType":"section","heading":"Compensation for exercise of enforcement powers","content":"130 Compensation for exercise of enforcement powers\n(1) A person may claim compensation from the Territory if the person\nsuffers loss or expense because of the exercise, or purported exercise,\nof a function under this part by a medicines and poisons inspector or\na person assisting the inspector.\n(2) Compensation may be claimed and ordered in a proceeding for—\n(a) compensation brought in a court of competent jurisdiction; or\n(b) an offence against this Act brought against the person making\nthe claim for compensation.\n(3) A court may order the payment of reasonable compensation for the\nloss or expense only if satisfied it is just to make the order in the\ncircumstances of the particular case.\n(4) A regulation may prescribe matters that may, must or must not be\ntaken into account by the court in considering whether it is just to\nmake the order.\n(5) To remove any doubt, this section does not authorise a court to order\nthe payment of compensation for regulated substances or regulated\ntherapeutic goods seized by a medicines and poisons inspector if the\nsubstance or good was recalled under the Therapeutic Goods\nAct 1989 (Cwlth).\n\nTaking and analysis of samples of substances Part 7.2\n","sortOrder":142},{"sectionNumber":"Part 7","sectionType":"part","heading":"2 Taking and analysis of samples","content":"Part 7.2 Taking and analysis of samples\nof substances\n","sortOrder":143},{"sectionNumber":"131","sectionType":"section","heading":"Inspector may buy samples without complying with pt 7.2","content":"131 Inspector may buy samples without complying with pt 7.2\nThis part does not stop a medicines and poisons inspector from\nbuying a sample of a substance for analysis for the routine monitoring\nof compliance with this Act without complying with the requirements\nof this part.\nNote For the admissibility of the analysis of a sample of a substance taken by\na medicines and poisons inspector, see s 181.\n","sortOrder":144},{"sectionNumber":"132","sectionType":"section","heading":"Person in charge etc to be told sample to be analysed","content":"132 Person in charge etc to be told sample to be analysed\n(1) This section applies if a medicines and poisons inspector proposes to\ntake, or takes, a sample of a substance for analysis from premises\nwhere a regulated substance is dealt with.\n(2) Before or as soon as practicable after taking the sample, the medicines\nand poisons inspector must tell a person in charge of the premises of\nthe inspector’s intention to have the sample analysed.\n(3) If a person in charge is not present or readily available, the medicines\nand poisons inspector must instead tell the person from whom the\nsample was obtained of the inspector’s intention to have the sample\nanalysed.\n\nPart 7.2 Taking and analysis of samples of substances\n","sortOrder":145},{"sectionNumber":"133","sectionType":"section","heading":"Payment for samples","content":"133 Payment for samples\n(1) This section applies if a medicines and poisons inspector takes a\nsample of a substance for analysis from premises where a regulated\nsubstance is dealt with.\n(2) The medicines and poisons inspector must pay, or offer to pay, the\nperson from whom the sample is taken—\n(a) the amount (if any) prescribed by regulation as the amount\npayable for the sample; or\n(b) if no amount is prescribed—the current market value of the\nsample.\n","sortOrder":146},{"sectionNumber":"134","sectionType":"section","heading":"Samples from packaged substances","content":"134 Samples from packaged substances\nIf a package of a substance contains 2 or more smaller packages of\nthe same substance, the medicines and poisons inspector may take\n1 of the smaller packages for analysis.\n","sortOrder":147},{"sectionNumber":"135","sectionType":"section","heading":"Procedures for dividing samples","content":"135 Procedures for dividing samples\n(1) This section—\n(a) applies to a sample of a substance being taken by a medicines\nand poisons inspector for analysis; and\n(b) is subject to section 136.\n(2) The medicines and poisons inspector must—\n(a) divide the sample into 3 parts, and mark and either seal or fasten\neach part; and\n(b) leave 1 part with the person told under section 132 (Person in\ncharge etc to be told sample to be analysed) of the inspector’s\nintention to have the sample analysed; and\n(c) keep 1 part for analysis; and\n(d) keep 1 part for future comparison with the other parts.\n\nTaking and analysis of samples of substances Part 7.2\n(3) If a sample of a substance taken by a medicines and poisons inspector\nis in the form of separate or severable objects, the inspector—\n(a) may take a number of the objects; and\n(b) if the inspector takes a number of the objects, must—\n(i) divide them into 3 parts each consisting of 1 or more of the\nobjects, or of the severable parts of the objects, and mark\nand either seal or fasten each part; and\n(ii) deal with the sample under subsection (2) (b) to (d).\n","sortOrder":148},{"sectionNumber":"136","sectionType":"section","heading":"Exception to usual procedures for dividing samples","content":"136 Exception to usual procedures for dividing samples\n(1) This section applies to a sample of a substance being taken by a\nmedicines and poisons inspector for analysis if dividing the substance\ninto 3 parts would, in the inspector’s opinion—\n(a) so affect or impair the composition or quality of the sample as\nto make the parts unsuitable for accurate analysis; or\n(b) result in the parts being too small for accurate analysis; or\n(c) otherwise make the sample unsuitable for analysis (including a\nmethod of analysis prescribed by regulation for the substance in\nrelation to which the sample is taken).\n(2) The medicines and poisons inspector may take as many samples as\nthe inspector considers necessary to allow an accurate analysis to be\nmade, and may deal with each sample in any way that is appropriate\nin the circumstances, instead of complying with section 135.\n\nPart 7.2 Taking and analysis of samples of substances\n","sortOrder":149},{"sectionNumber":"137","sectionType":"section","heading":"Certificates of analysis by authorised analysts","content":"137 Certificates of analysis by authorised analysts\n(1) The analysis of a sample of a substance for the chief health officer\nmust be carried out by, or under the supervision of, an authorised\nanalyst.\n(2) An authorised analyst who analyses the sample must give to the chief\nhealth officer a certificate of analysis that—\n(a) is signed and dated by the analyst; and\n(b) contains a written report of the analysis that sets out the findings;\nand\n(c) identifies the method of analysis.\nNote For evidentiary certificates by authorised analysts, see the Public Health\nAct 1997, s 135A.\nauthorised analyst means an analyst appointed under the Public\nHealth Act 1997, section 15 who is authorised under that Act to\nexercise a function under this Act.\n\nChapter 8 Restrictions on dealing with\nregulated substances and\nPart 8.1 Authorisations—disciplinary\naction\n138 Application—pt 8.1\n(1) This part does not apply in relation to a dealing by a person with a\nregulated substance or regulated therapeutic good if the dealing is—\n(a) authorised by a licence or permit under a Commonwealth Act;\nor\n(b) the dealing is otherwise in accordance with a Commonwealth\nAct.\n(2) To remove any doubt, this part does not limit the power of anyone\nexercising a function under this Act to—\n(a) make a notification under the Health Practitioner Regulation\nNational Law (ACT) about a health practitioner; or\n(b) make a complaint under the Veterinary Practice Act 2018, part 5\nabout a veterinary practitioner.\nNote Function includes authority, duty and power (see Legislation Act, dict,\npt 1).\n\n","sortOrder":150},{"sectionNumber":"139","sectionType":"section","heading":"Definitions—pt 8.1","content":"139 Definitions—pt 8.1\nauthorisation holder means a person who is, or has been, authorised\nto deal with a regulated substance or regulated therapeutic good.\ndisciplinary action—see section 141.\ndisciplinary notice—see section 142.\nground for disciplinary action, against an authorisation holder—see\nsection 140.\ninterstate wholesaler means a person who is or has been authorised\nunder—\n(a) section 20 (4) (When authorised to deal with regulated\nsubstances) to supply a regulated substance by wholesale; or\n(b) section 22 (2) (When authorised to deal with regulated\ntherapeutic goods) to supply a regulated therapeutic good by\nwholesale.\n","sortOrder":151},{"sectionNumber":"140","sectionType":"section","heading":"Grounds for disciplinary action against authorisation","content":"140 Grounds for disciplinary action against authorisation\nholders\n(1) Each of the following is a ground for disciplinary action against an\nauthorisation holder:\n(a) the authorisation holder has given information to the chief health\nofficer that was false or misleading in a material particular;\n(b) the authorisation holder has failed to give information required\nto be given under this Act;\n(c) the authorisation holder has contravened a condition of the\nauthorisation;\n\n(d) the authorisation holder, or an agent or employee of the\nauthorisation holder, has contravened this Act (whether or not\nthe authorisation holder or employee is convicted, or found\nguilty, of the offence);\nNote A reference to an Act includes a reference to the statutory\ninstruments made or in force under the Act, including any\nregulation (see Legislation Act, s 104).\n(e) if the authorisation holder is or has been a licence-holder—\n(i) when the chief health officer issued the licence, grounds\nexisted to refuse the application for the licence but the chief\nhealth officer was not aware of them; or\n(ii) the licence-holder is not, or is no longer, a suitable person\nfor a licence; or\n(iii) the licence-holder no longer carries out the dealing to\nwhich the licence relates; or\n(iv) a ground mentioned in paragraph (a), (b), (c) or (d) applies\nin relation to a close associate of, or influential person for,\nthe licence-holder; or\n(v) a close associate of, or influential person for, the\nlicence-holder is not, or is no longer, a suitable person for\nthe licence;\n(f) if the person is or was an interstate wholesaler—\n(i) the person, or an agent or employee of the person, supplied\na regulated substance or regulated therapeutic good to\nsomeone not authorised to obtain it; or\n(ii) the person, or an agent or employee of the person,\ncontravened a condition or restriction that applies or\napplied to the person under a corresponding law or a\n\n(2) In subsection (1) (d), a reference to a contravention of this Act\nincludes a reference to the following:\n(a) a contravention of the Criminal Code in relation to a document\ncompleted, kept or given, or required to be completed, kept or\ngiven, under this Act;\n(b) a contravention of the Criminal Code in relation to anything else\ndone, or not done, under this Act.\nNote See also the Criminal Code, pt 2.4 (Extensions of criminal responsibility)\nand pt 2.5 (Corporate criminal responsibility).\nclose associate—see section 79.\ninfluential person—see section 80.\n","sortOrder":152},{"sectionNumber":"141","sectionType":"section","heading":"Disciplinary action against authorisation holders","content":"141 Disciplinary action against authorisation holders\n(1) Each of the following is disciplinary action when taken against an\nauthorisation holder (other than a former authorisation holder):\n(a) reprimanding the authorisation holder;\n(b) requiring the authorisation holder, or an employee of the\nauthorisation holder, to complete a stated course of training to\nthe satisfaction of the chief health officer or another stated\nperson;\n(c) imposing a condition on the authorisation holder’s authority to\ndeal with a regulated substance or regulated therapeutic good;\n(d) amending the authorisation holder’s authority to deal with a\nregulated substance or regulated therapeutic good;\n\n(e) suspending the authorisation holder’s authority to deal with a\nregulated substance or regulated therapeutic good, or a\nparticular authorised dealing under the authorisation—\n(i) for a stated period; or\n(ii) until the authorisation holder, or an employee of the\nauthorisation holder, completes a stated course of training\nto the satisfaction of the chief health officer or someone\nelse; or\n(iii) until a stated event happens;\n(f) cancelling the authorisation holder’s authority to deal with a\nregulated substance or regulated therapeutic good;\n(g) if the authorisation holder is an interstate wholesaler—\nprohibiting the authorisation holder from supplying a regulated\nsubstance or regulated therapeutic good by wholesale in the\nACT;\n(h) if the authorisation holder is authorised to access and use the\nmonitored medicines database—amending, suspending or\ncancelling the authority to access and use the database.\n(2) Each of the following is disciplinary action when taken against a\nformer authorisation holder:\n(a) reprimanding the former authorisation holder;\n(b) disqualifying the former authorisation holder from being\nauthorised, or authorised in a particular way, to deal with a\nregulated substance or regulated therapeutic good—\n(i) for a stated period; or\n(ii) until the former authorisation holder, or an employee of the\nformer authorisation holder, completes a stated course of\ntraining to the satisfaction of the chief health officer or\nsomeone else; or\n\n(iii) until a stated event happens;\n(c) if the former authorisation holder was an interstate wholesaler—\nprohibiting the former authorisation holder from supplying a\nregulated substance or regulated therapeutic good by wholesale\nin the ACT.\n","sortOrder":153},{"sectionNumber":"142","sectionType":"section","heading":"Taking disciplinary action against authorisation holders","content":"142 Taking disciplinary action against authorisation holders\n(1) If the chief health officer is satisfied that a ground for disciplinary\naction exists, or may exist, in relation to an authorisation holder, the\nchief health officer may give the authorisation holder a notice (a\ndisciplinary notice).\n(2) The disciplinary notice must—\n(a) state the ground for disciplinary action; and\n(b) tell the authorisation holder that they may, not later than 3 weeks\nafter the day the authorisation holder is given the notice, give a\nwritten response to the chief health officer about the notice.\n(3) If, after considering any response given not later than the end of the\n3-week period, the chief health officer is satisfied that a ground for\ndisciplinary action exists in relation to the authorisation holder, the\nchief health officer may take disciplinary action against the\nauthorisation holder.\n(4) To remove any doubt, the disciplinary action may consist of 2 or more\nof the actions mentioned in section 141.\n(5) The disciplinary action takes effect when the authorisation holder\nreceives written notice of the action or, if the notice states a later time\nof effect, at the stated time.\n\n","sortOrder":154},{"sectionNumber":"143","sectionType":"section","heading":"Immediate suspension of authorisations","content":"143 Immediate suspension of authorisations\n(1) This section applies if the chief health officer has given, or is\nconsidering whether to give, a disciplinary notice to an authorisation\nholder.\n(2) The chief health officer may give the authorisation holder a written\nnotice (an immediate suspension notice) suspending—\n(a) the authorisation holder’s authority to deal with a regulated\nsubstance or regulated therapeutic good; or\n(b) a particular authorised dealing under the authorisation.\n(3) However, the chief health officer may suspend the authorisation\nunder subsection (2) only if—\n(a) the chief health officer has taken into account the circumstances\nleading to the decision to give or consider giving the disciplinary\nnotice and the grounds stated, or that may be stated, in the\ndisciplinary notice; and\n(b) the chief health officer believes on reasonable grounds that it is\nin the public interest that the authorisation be suspended before\na decision is made whether or not to take action against the\nauthorisation holder under section 142.\n(4) If an immediate suspension notice is given to the authorisation holder,\nthe authorisation holder’s authority to deal with the regulated\nsubstance or regulated therapeutic good to which the authorisation\nrelates is suspended when the notice is given to the authorisation\nholder.\nNote If the authorisation is a licence or approval, the licence or approval must\nbe returned to the chief health officer, see s 145.\n\n(5) If the authorisation holder is given an immediate suspension notice\nbecause the chief health officer is considering whether to give a\ndisciplinary notice to the authorisation holder, the chief health officer\nmust, as soon as practicable—\n(a) give a disciplinary notice to the authorisation holder; or\n(b) tell the authorisation holder in writing that a disciplinary notice\nwill not be given to the authorisation holder.\n(6) An immediate suspension notice ends—\n(a) if the chief health officer decides not to give a disciplinary notice\nto the authorisation holder—when the chief health officer tells\nthe authorisation holder about the decision under subsection (5)\n(b); or\n(b) if a disciplinary notice is given to the authorisation holder—\n(i) when any disciplinary action takes effect; or\n(ii) the authorisation holder is given written notice by the chief\nhealth officer that no disciplinary action will be taken.\n","sortOrder":155},{"sectionNumber":"144","sectionType":"section","heading":"Effect of suspension of authorisations","content":"144 Effect of suspension of authorisations\n(1) If an authorisation to deal with a regulated substance or regulated\ntherapeutic good is suspended, the authorisation does not authorise\nthe authorisation holder to carry on any dealing with the regulated\nsubstance or regulated therapeutic good under the authorisation\nduring the suspension.\n(2) If an authorised dealing with a regulated substance or regulated\ntherapeutic good under an authorisation is suspended, the\nauthorisation—\n(a) does not authorise the authorisation holder to carry out the\ndealing under the authorisation during the suspension; and\n(b) is taken to be amended under this part to the extent necessary to\ngive effect to the suspension.\n\n","sortOrder":156},{"sectionNumber":"145","sectionType":"section","heading":"Return of certain licences and approvals","content":"145 Return of certain licences and approvals\n(a) the person is the holder of—\n(i) a licence; or\n(ii) an approval under section 20 (1) (c) (When authorised to\ndeal with regulated substances) or section 22 (1) (c) (When\nauthorised to deal with regulated therapeutic goods); and\n(b) the person’s authorisation to deal with a regulated substance or\nregulated therapeutic good is amended, suspended or cancelled\nunder this part; and\n(c) the person fails to return the licence or approval to the chief\nhealth officer as soon as practicable (but not later than 7 days)\nafter the day the person is told about the amendment, suspension\nor cancellation.\nMaximum penalty: 20 penalty units.\n","sortOrder":157},{"sectionNumber":"146","sectionType":"section","heading":"Action by chief health officer in relation to certain","content":"146 Action by chief health officer in relation to certain\nlicences and approvals\n(1) If a licence or approval amended under this part is returned to the\nchief health officer, the chief health officer must—\n(a) amend the licence or approval and return it to the authorisation\nholder; or\n(b) give the authorisation holder a replacement licence or approval\nthat includes the amendment.\nNote A licence or approval is taken to be amended if an authorised dealing\nunder the licence or approval is suspended (see s 144 (2)).\n\n(2) If a licence or approval is suspended under this part and the\nsuspension ends before the end of the term of the licence or approval,\nthe chief health officer must—\n(a) return the licence or approval to the authorisation holder; or\n(b) give the authorisation holder a replacement licence or approval\nfor the remainder of the term of the licence or approval.\napproval means an approval under section 20 (1) (c) (When\nauthorised to deal with regulated substances) or section 22 (1) (c)\n(When authorised to deal with regulated therapeutic goods).\n\nControlled medicines and prohibited substances—disqualification by\ncourts\n","sortOrder":158},{"sectionNumber":"Part 8","sectionType":"part","heading":"2","content":"Part 8.2\nPart 8.2 Controlled medicines and\nprohibited substances—\ndisqualification by courts\n","sortOrder":159},{"sectionNumber":"147","sectionType":"section","heading":"Definitions—pt 8.2","content":"147 Definitions—pt 8.2\ndrug offence means an offence against—\n(a) chapter 4 (Offences relating to regulated substances) in relation\nto a controlled medicine or prohibited substance; or\n(b) the Criminal Code, chapter 6 (Serious drug offences); or\n(c) the Drugs of Dependence Act 1989, part 10 (Offences).\nrelevant person means—\n(a) a person who is authorised to deal with a regulated substance; or\n(b) a person who is authorised under this Act or another territory\nlaw to possess a controlled medicine or prohibited substance.\n","sortOrder":160},{"sectionNumber":"148","sectionType":"section","heading":"Drug offences—disqualification from dealing","content":"148 Drug offences—disqualification from dealing\n(1) This section applies if a relevant person is convicted, or found guilty,\nof a drug offence.\n(2) The convicting court may direct that the relevant person must not,\nduring a stated period, deal with a controlled medicine or prohibited\nsubstance (or both) in the ways stated in the direction.\n(3) However, the court must not give the direction unless satisfied that\ngiving the direction is in the interests of the person or the public.\n(4) The Magistrates Court Act 1930, section 208 (which is about appeals\nin criminal matters) applies in relation to the direction as if the\ndirection were a penalty imposed by the court in relation to the\nconviction of a person of an offence.\n\nPart 8.2 Controlled medicines and prohibited substances—disqualification by\ncourts\n","sortOrder":161},{"sectionNumber":"149","sectionType":"section","heading":"Notice of disqualification from dealing","content":"149 Notice of disqualification from dealing\n(1) If a court gives a direction under section 148 (2), the court’s registrar\nmust give a copy of the direction to—\n(a) the relevant person; and\n(b) the chief health officer.\n(2) The chief health officer must give a copy of the direction to—\n(a) the relevant person’s employer (if any); and\n(b) if the relevant person is a veterinary practitioner—the veterinary\npractitioners board; and\n(c) if the relevant person is a health practitioner—the relevant\nnational board for the person under the Health Practitioner\nRegulation National Law (ACT).\n","sortOrder":162},{"sectionNumber":"150","sectionType":"section","heading":"Effect of disqualification from dealing","content":"150 Effect of disqualification from dealing\n(1) This section applies if a direction is given under section 148 (2) (Drug\noffences—disqualification from dealing) in relation to a relevant\n(2) The relevant person’s authorisation to deal with a controlled medicine\nor prohibited substance is taken, to the extent necessary to give effect\nto the court’s direction, not to be in force for the period stated in the\ndirection.\n\nSurrender of prescribed authorisations Part 8.3\nPart 8.3 Surrender of prescribed\nauthorisations\n","sortOrder":163},{"sectionNumber":"151","sectionType":"section","heading":"Application—pt 8.3","content":"151 Application—pt 8.3\nThis part applies to a person who is authorised under a regulation to\ndeal with a regulated substance or regulated therapeutic good, other\nthan—\n(a) a licence-holder; or\nNote For the surrender of a licence, see s 97.\n(b) a person who is dealing with a medicine or poison in accordance\nwith an approval by the chief health officer under a regulation;\nor\nNote The approval may be revoked by the chief health officer (see\nLegislation Act, s 46 (1)).\n(c) a medicines and poisons inspector; or\n(d) a person prescribed by regulation.\n","sortOrder":164},{"sectionNumber":"152","sectionType":"section","heading":"Surrender of authorisation under regulation","content":"152 Surrender of authorisation under regulation\n(1) A person to whom this part applies may, by written notice\n(a surrender notice) given to the chief health officer, declare that the\nperson does not wish to be authorised under a regulation—\n(a) to deal with a stated regulated substance or regulated therapeutic\ngood; or\n(b) for stated dealings with a stated regulated substance or regulated\ntherapeutic good.\n\nPart 8.3 Surrender of prescribed authorisations\n(2) A surrender notice—\n(a) may state a period during which the declaration is to apply or an\nevent on which the declaration ends; and\n(b) may be revoked by giving the chief health officer written notice\nof the revocation at least 7 days before the revocation takes\neffect.\n(3) If the chief health officer receives from a person a surrender notice or\nnotice revoking a surrender notice, the chief health officer must give\na copy of the notice to—\n(a) the person’s employer (if any); and\n(b) if the relevant person is a veterinary practitioner—the veterinary\npractitioners board; and\n(c) if the relevant person is a health practitioner—the relevant\nnational board for the person under the Health Practitioner\nRegulation National Law (ACT).\n","sortOrder":165},{"sectionNumber":"153","sectionType":"section","heading":"Effect of surrender of authorisation under regulation","content":"153 Effect of surrender of authorisation under regulation\n(1) This section applies while a surrender notice under section 152\nrelating to a regulated substance or regulated therapeutic good is in\nforce in relation to a person.\n(2) The person’s authorisation to deal with the regulated substance or\nregulated therapeutic good is taken, to the extent necessary to give\neffect to the surrender notice, not to be in force while the notice is in\nforce.\n\nNotification and review of decisions Chapter 9\n","sortOrder":166},{"sectionNumber":"Part 9","sectionType":"part","heading":"Notification and review of","content":"Chapter 9 Notification and review of\ndecisions\n","sortOrder":167},{"sectionNumber":"154","sectionType":"section","heading":"Meaning of reviewable decision—ch 9","content":"154 Meaning of reviewable decision—ch 9\nreviewable decision means a decision mentioned in\nschedule 1, column 3 under a provision of this Act mentioned in\ncolumn 2 in relation to the decision.\n","sortOrder":168},{"sectionNumber":"155","sectionType":"section","heading":"Reviewable decision notices","content":"155 Reviewable decision notices\nIf a person makes a reviewable decision, the person must give a\nreviewable decision notice to each entity mentioned in schedule 1,\ncolumn 4 in relation to the decision.\nNote The person must also take reasonable steps to give a reviewable decision\nnotice to any other person whose interests are affected by the decision\n(see ACT Civil and Administrative Tribunal Act 2008, s 67A).\n","sortOrder":169},{"sectionNumber":"155A","sectionType":"section","heading":"Applications for review","content":"155A Applications for review\nThe following may apply to the ACAT for a review of a reviewable\ndecision:\n(a) an entity mentioned in schedule 1, column 4 in relation to the\ndecision;\n(b) any other person whose interests are affected by the decision.\n\n","sortOrder":170},{"sectionNumber":"Part 10","sectionType":"part","heading":"Incorporation of","content":"Chapter 10 Incorporation of\nCommonwealth therapeutic\n","sortOrder":171},{"sectionNumber":"156","sectionType":"section","heading":"Definitions—ch 10","content":"156 Definitions—ch 10\napplied provisions means the Commonwealth therapeutic goods laws\nthat apply as a law of the Territory under section 157.\nCommonwealth administrative laws means—\n(a) the Administrative Review Tribunal Act 2024 (Cwlth); and\n(b) the Freedom of Information Act 1982 (Cwlth); and\n(c) the Ombudsman Act 1976 (Cwlth); and\n(d) the Privacy Act 1988 (Cwlth).\nCommonwealth Minister means the Minister responsible for\nadministering the Commonwealth therapeutic goods laws.\nCommonwealth Secretary means the Secretary of the\nCommonwealth department that is—\n(a) administered by the Commonwealth Minister; and\n(b) responsible for the Commonwealth therapeutic goods laws.\n\nPreliminary Part 10.1\nCommonwealth therapeutic goods laws means the Therapeutic\nGoods Act 1989 (Cwlth) (including the statutory instruments under\nthe Act) as modified by this Act.\nNote 1 A reference to an Act includes a reference to the statutory instruments\nNote 2 A reference to a law includes a reference to the law as originally made\nand as in force from time to time (see Legislation Act, s 102).\nNote 3 Commonwealth legislation is available at www.legislation.gov.au.\n\nPart 10.2 Application in ACT of\nCommonwealth therapeutic\n","sortOrder":172},{"sectionNumber":"157","sectionType":"section","heading":"Application of Commonwealth therapeutic goods laws to","content":"157 Application of Commonwealth therapeutic goods laws to\nACT\n(1) The Commonwealth therapeutic goods laws apply as a law of the\nNote Commonwealth therapeutic goods laws—see s 156.\n(2) This Act may modify the applied provisions.\n(3) The Commonwealth therapeutic goods laws also apply as if they\nextended to—\n(a) an act done or omitted to be done by a person who is not a\ncorporation; and\n(b) an act done or omitted to be done in the course of trade or\ncommerce within the limits of the Territory.\n","sortOrder":173},{"sectionNumber":"158","sectionType":"section","heading":"Interpretation of Commonwealth therapeutic goods laws","content":"158 Interpretation of Commonwealth therapeutic goods laws\n(1) The Acts Interpretation Act 1901 (Cwlth) applies as a law of the\nTerritory in relation to the interpretation of the applied provisions as\nif the applied provisions were Commonwealth laws.\nNote 1 The Acts Interpretation Act 1901 (Cwlth) is available at\nwww.legislation.gov.au.\nNote 2 A reference to a law includes a reference to the law as originally made\nand as in force from time to time (see Legislation Act, s 102).\n\nFunctions under applied provisions Division 10.2.2\n(2) The Legislation Act does not apply to the applied provisions.\n","sortOrder":174},{"sectionNumber":"Div 10","sectionType":"division","heading":"2.2 Functions under applied provisions","content":"Division 10.2.2 Functions under applied provisions\n","sortOrder":175},{"sectionNumber":"159","sectionType":"section","heading":"Functions of Commonwealth Minister","content":"159 Functions of Commonwealth Minister\nThe Commonwealth Minister has the same functions under the\napplied provisions as the Commonwealth Minister has under the\nCommonwealth therapeutic goods laws as those laws apply to the\n","sortOrder":176},{"sectionNumber":"160","sectionType":"section","heading":"Functions of Commonwealth Secretary","content":"160 Functions of Commonwealth Secretary\nThe Commonwealth Secretary has the same functions under the\napplied provisions as the Commonwealth Secretary has under the\nCommonwealth therapeutic goods laws as those laws apply to the\n","sortOrder":177},{"sectionNumber":"161","sectionType":"section","heading":"Functions of other people","content":"161 Functions of other people\nA medicines and poisons inspector or Commonwealth officer under\nthe Commonwealth therapeutic goods laws has the same functions\nunder the applied provisions as the inspector or officer has under the\nCommonwealth therapeutic goods laws as the laws apply to the\n","sortOrder":178},{"sectionNumber":"162","sectionType":"section","heading":"Delegations by Commonwealth Minister or Secretary","content":"162 Delegations by Commonwealth Minister or Secretary\nA delegation by the Commonwealth Minister or the Commonwealth\nSecretary under the Therapeutic Goods Act 1989 (Cwlth), section 57\nis taken to extend to, and have effect for the purposes of, the\ncorresponding provision of the applied provisions.\n\nDivision 10.2.3 Applied provisions—administrative law matters\n","sortOrder":179},{"sectionNumber":"163","sectionType":"section","heading":"Appointments under Commonwealth therapeutic goods","content":"163 Appointments under Commonwealth therapeutic goods\nlaws\nThe appointment of a person to a position under a provision of the\nCommonwealth therapeutic goods laws is taken to extend to, and\nhave effect for the purposes of, the applied provisions.\nDivision 10.2.3 Applied provisions—administrative\nlaw matters\n","sortOrder":180},{"sectionNumber":"164","sectionType":"section","heading":"Application of Commonwealth administrative laws to","content":"164 Application of Commonwealth administrative laws to\napplied provisions\n(1) The Commonwealth administrative laws apply as laws of the\nTerritory to any matter arising in relation to the applied provisions as\nif those provisions were a law of the Commonwealth and not a\nterritory law.\nNote Subsection (4) contains an exception to s (1).\n(2) For the purposes of a territory law, a matter arising in relation to the\napplied provisions—\n(a) is taken to be a matter arising in relation to the laws of the\nCommonwealth in the same way as it would if the applied\nprovisions were a law of the Commonwealth; and\n(b) is taken not to be a matter arising in relation to the laws of the\n(3) However, a regulation may modify the operation of subsection (2).\n(4) A provision of a Commonwealth administrative law applied under\nsubsection (1) that purports to give jurisdiction to a federal court is\ntaken not to have that effect.\n\nApplied provisions—offences Division 10.2.4\n","sortOrder":181},{"sectionNumber":"165","sectionType":"section","heading":"Functions given to Commonwealth officers and","content":"165 Functions given to Commonwealth officers and\nauthorities\n(1) A Commonwealth administrative law applying as a territory law\nunder section 164 that gives a Commonwealth officer or\nCommonwealth authority a function also gives the officer or authority\nthe same function in relation to a matter arising in relation to the\napplied provisions.\n(2) In exercising a function given by this section, the Commonwealth\nofficer or Commonwealth authority must act as nearly as practicable\nas the officer or authority would act in exercising the same function\nunder the Commonwealth administrative law.\n(3) A function given to a Commonwealth officer or Commonwealth\nauthority because of this section cannot be exercised by a territory\nofficer or territory authority.\n","sortOrder":182},{"sectionNumber":"166","sectionType":"section","heading":"Object—div 10.2.4","content":"166 Object—div 10.2.4\n(1) The object of this division is to further the object of this chapter by\nproviding for an offence against the applied provisions to be treated\nas if it were an offence against a law of the Commonwealth.\n(2) For subsection (1), the purposes for which an offence is to be treated\nas if it were an offence against a law of the Commonwealth include,\nfor example—\n(a) the investigation and prosecution of offences; and\n(b) the arrest, custody, bail, trial and conviction of offenders or\npeople charged with offences; and\n\n(c) proceedings relating to matters mentioned in paragraph (a)\nor (b); and\n(d) appeals and review relating to criminal proceedings and to\nproceedings of the kind mentioned in paragraph (c); and\n(e) the sentencing, punishment and release of people convicted of\noffences; and\n(f) fines, penalties and forfeitures; and\n(g) liability to make reparation in connection with offences; and\n(h) proceeds of crime; and\n(i) spent convictions.\n","sortOrder":183},{"sectionNumber":"167","sectionType":"section","heading":"Application of Commonwealth criminal laws to offences","content":"167 Application of Commonwealth criminal laws to offences\nagainst applied provisions\n(1) The relevant Commonwealth laws apply as laws of the Territory in\nrelation to an offence against the applied provisions as if the applied\nprovisions were a law of the Commonwealth and not a law of the\n(2) For the purposes of a territory law, an offence against the applied\nprovisions—\n(a) is taken to be an offence against the laws of the Commonwealth\nin the same way as it would be if the applied provisions were a\nlaw of the Commonwealth; and\n(b) is taken not to be an offence against the laws of the Territory.\n(3) However, a regulation may modify the operation of subsection (2).\n\nApplied provisions—offences Division 10.2.4\nrelevant Commonwealth laws means—\n(a) the Commonwealth laws that would apply in relation to an\noffence against the applied provisions if it were an offence\nagainst a law of the Commonwealth; and\n(b) includes any Commonwealth law in relation to a matter\nmentioned in section 166 (2) (a) to (i).\n","sortOrder":184},{"sectionNumber":"168","sectionType":"section","heading":"Functions of Commonwealth officers and authorities","content":"168 Functions of Commonwealth officers and authorities\nrelating to offences\n(1) A provision of a Commonwealth law applying under section 167 that\ngives a Commonwealth officer or Commonwealth authority a\nfunction in relation to an offence against the Commonwealth\ntherapeutic goods laws also gives the officer or authority the same\nfunction in relation to an offence against the corresponding provision\nof the applied provisions.\n(2) In exercising a function given by subsection (1), the Commonwealth\nofficer or Commonwealth authority must act as nearly as practicable\nas the officer or authority would act in exercising the same function\nin relation to an offence against the corresponding provision of the\nCommonwealth therapeutic goods laws.\n","sortOrder":185},{"sectionNumber":"169","sectionType":"section","heading":"No double jeopardy for offences against applied","content":"169 No double jeopardy for offences against applied\nprovisions\n(a) an act or omission is an offence against both the applied\nprovisions and the Commonwealth therapeutic goods laws; and\n(b) the offender has been punished for the offence under the\nCommonwealth laws.\n\n(2) The offender is not liable to be punished for the offence under the\napplied provisions.\n","sortOrder":186},{"sectionNumber":"170","sectionType":"section","heading":"Commonwealth may keep fees paid to Commonwealth","content":"170 Commonwealth may keep fees paid to Commonwealth\nSecretary\nThe Commonwealth may keep fees paid to, or recovered by, the\nCommonwealth Secretary in relation to the exercise of functions\ngiven to the Secretary by the applied provisions.\n\nChapter 11 Procedural and evidentiary\nprovisions\nPart 11.1 General provisions about\noffences against Act\n171 Acts and omissions of representatives of individuals\nfault element includes intention, knowledge, recklessness, opinion,\nbelief or purpose but does not include negligence.\noffence against this Act includes an offence against the Criminal\nCode in relation to—\n(a) a document completed, kept or given, or required to be\ncompleted, kept or given, under this Act; and\n(b) anything else done, or not done, under this Act.\nperson means an individual.\nNote See the Criminal Code, pt 2.5 for provisions about corporate criminal\nresponsibility.\nrepresentative, of a person, means an employee or agent of the\n(2) This section applies to a prosecution for an offence against—\n(a) a provision of—\n(i) chapter 4 (Offences relating to regulated substances); or\n(ii) chapter 5 (Offences relating to regulated therapeutic\ngoods); or\n(b) section 96 (Contravening licence conditions).\n\n(3) Conduct engaged in by a representative of a person within the scope\nof the representative’s actual or apparent authority is also taken to\nhave been engaged in by the person.\n(4) However, subsection (3) does not apply if the person establishes that\nthe person took all reasonable steps to prevent the conduct.\n(5) In deciding whether the person took all reasonable steps to prevent\nthe conduct, a court must consider—\n(a) any action the person took to ensure that the representative had\na reasonable knowledge and understanding of the requirement\nto comply with the contravened provision; and\n(b) the level of management, control or supervision that was\nappropriate for the person to exercise over the representative.\n(6) Subsection (5) does not limit the matters that the court may consider.\n(7) If it is relevant to prove that a person had a fault element or was\nnegligent in relation to a physical element of an offence, it is enough\nto show that—\n(a) the conduct relevant to the physical element was engaged in by\na representative of the person within the scope of the\nrepresentative’s actual or apparent authority; and\n(b) the representative had the fault element or was negligent in\nrelation to the physical element.\n(8) A person may rely on the Criminal Code, section 36 (Mistake of\nfact—strict liability) in relation to conduct by a representative that\nwould be an offence by the person only if—\n(a) the representative was under a mistaken but reasonable belief\nabout the facts that, had they existed, would have meant that the\nconduct would not have been an offence; and\n(b) the person proves that the person exercised appropriate diligence\nto prevent the conduct.\n\n(9) A person may not rely on the Criminal Code, section 39 (Intervening\nconduct or event) in relation to a physical element of an offence\nbrought about by someone else if the other person is a representative\nof the person.\n(10) A person who is convicted of an offence cannot be punished by\nimprisonment for the offence if the person would not have been\nconvicted of the offence without subsection (3) or subsection (7).\n","sortOrder":187},{"sectionNumber":"172","sectionType":"section","heading":"Criminal liability of executive officers","content":"172 Criminal liability of executive officers\n(1) An executive officer of a corporation commits an offence if—\n(a) the corporation commits a relevant offence; and\n(b) the officer was reckless about whether the relevant offence\nwould be committed; and\n(c) the officer was in a position to influence the conduct of the\ncorporation in relation to the commission of the relevant\noffence; and\n(d) the officer failed to take reasonable steps to prevent the\ncommission of the relevant offence.\nMaximum penalty: The maximum penalty that may be imposed for\nthe commission of the relevant offence by an individual.\n(2) In deciding whether the executive officer took (or failed to take)\nreasonable steps to prevent the commission of the relevant offence, a\ncourt must consider the following:\n(a) any action the officer took directed towards ensuring the\nfollowing (to the extent that the action is relevant to the act or\nomission):\n(i) that the corporation arranges regular professional\nassessments of the corporation’s compliance with the\nprovision to which the relevant offence relates;\n\n(ii) that the corporation implements any appropriate\nrecommendation arising from such an assessment;\n(iii) that the corporation’s employees, agents and contractors\nhave a reasonable knowledge and understanding of the\nrequirement to comply with the provision to which the\nrelevant offence relates;\n(b) any action the officer took when the officer became aware that\nthe relevant offence was, or might be, about to be committed.\n(3) Subsection (2) does not limit the matters the court may consider.\n(4) Subsection (1) does not apply if the corporation would have a defence\nto a prosecution for the relevant offence.\nNote The defendant has an evidential burden in relation to the matters\nmentioned in s (4) (see Criminal Code, s 58).\n(5) This section applies whether or not the corporation is prosecuted for,\nor convicted of, the relevant offence.\n(6) In this section:\nrelevant offence means an offence against any of the following:\n(a) section 26 (1) (Supplying declared substances);\n(b) section 28 (Supplying declared substances on invalid supply\nauthorities—recklessness);\n(c) section 29 (Supplying declared substances on invalid supply\nauthorities—other offences);\n(d) section 30 (Cancellation etc of invalid supply authorities for\ndeclared substances);\n(e) section 34 (1), (2) or (3) (Discarding declared etc substances);\n(f) section 35 (1) (Obtaining certain declared substances);\n(g) section 36 (Possessing certain declared substances);\n\n(h) section 37 (1) or (4) (Administering certain declared\n(i) section 38 (1) (Issuing purchase orders for declared substances);\n(j) section 40 (1) or (3) (Prescribing medicines);\n(k) section 41 (Issuing requisitions for medicines);\n(l) section 42 (Issuing standing orders for medicines);\n(m) section 43 (1) or (2) (Medicines for animals not to be prescribed\netc for human use);\n(n) section 44 (Contravening authorisation conditions for regulated\n(o) section 45 (1) (Pretending to be authorised to deal with regulated\nsubstance);\n(p) section 55 (Registers—changes etc to entries);\n(q) section 59 (1) (Packaging of supplied regulated substances);\n(r) section 60 (1) (Labelling of supplied regulated substances);\n(s) section 61 (Storing declared substances);\n(t) section 64 (2) (False statements to obtain certain regulated\nsubstances etc);\n(u) section 65 (Falsely representing substance is regulated);\n(v) section 68 (Vending machines—use for supply of regulated\n(w) section 69 (Vending machines—use for supply of unscheduled\nmedicines);\n(x) section 70 (Manufacture, supply and use of paints containing\nwhite lead);\n(y) section 71 (3) (Manufacture, supply and use of paints for certain\npurposes);\n\n(z) section 72 (Manufacture, supply and use of paints for toys);\n(za) section 73 (Manufacture, supply and use of paints containing\npesticides);\n(zb) section 74 (1) (Supplying regulated therapeutic goods);\n(zc) section 76 (Pretending to be authorised to deal with regulated\ntherapeutic goods);\n(zd) section 77 (Falsely representing thing is regulated);\n(ze) section 96 (1) (Contravening licence conditions).\n","sortOrder":188},{"sectionNumber":"173","sectionType":"section","heading":"No defence to claim deterioration of sample","content":"173 No defence to claim deterioration of sample\nIt is not a defence in a proceeding for an offence against this Act for\na defendant to claim that any part of a sample kept for future\ncomparison with a sample that has been analysed has, from natural\ncauses, deteriorated, perished or undergone material change.\n","sortOrder":189},{"sectionNumber":"174","sectionType":"section","heading":"Remedial orders by court for offences","content":"174 Remedial orders by court for offences\n(a) a person is convicted, or found guilty, of an offence against this\nAct; and\n(b) the prosecutor asks the court to make an order under this section;\nand\n(c) it appears to the court that the person could partly or completely\nrectify a state of affairs that arose as a direct or indirect result of\nthe conduct that was the subject of the offence.\nNote Found guilty—see the Legislation Act, dict, pt 1.\n\n(2) The court may order the person to take any steps that it considers are\nnecessary and appropriate to rectify the state of affairs and that are\nwithin the person’s power to take.\n(3) If a court makes an order under this section, it may also make any\nother consequential orders (including orders about costs) that it\nconsiders appropriate.\n","sortOrder":190},{"sectionNumber":"175","sectionType":"section","heading":"Court may order costs and expenses","content":"175 Court may order costs and expenses\n(1) A court that hears a proceeding for an offence against this Act may\nmake any order it considers appropriate in relation to costs and\nexpenses in relation to the examination, seizure, detention, storage,\nanalysis (including further analysis), destruction or other disposition\nof anything the subject of the proceeding.\n(2) This section does not affect any other power of the court to award\ncosts.\n","sortOrder":191},{"sectionNumber":"176","sectionType":"section","heading":"Court may order forfeiture","content":"176 Court may order forfeiture\nA court that convicts a person, or finds a person guilty, of an offence\nagainst this Act may order the forfeiture to the Territory of anything\nthat was used in the commission of the offence.\n","sortOrder":192},{"sectionNumber":"177","sectionType":"section","heading":"Notices of noncompliance by territory entities","content":"177 Notices of noncompliance by territory entities\n(1) This section applies if a territory entity (other than a territory-owned\ncorporation) commits an offence against this Act and the offence is\nan infringement notice offence.\nNote A reference to an Act includes a reference to statutory instruments made\n\n(2) An authorised person for the infringement notice offence may serve\na notice of noncompliance on the responsible director-general for the\nterritory entity.\nNote For how documents may be served, see the Legislation Act, pt 19.5.\nauthorised person, for an infringement notice offence, means an\nauthorised person for the infringement notice offence under the\nMagistrates Court Act 1930, section 134A.\nresponsible director-general—see the Auditor-General Act 1996,\ndictionary.\nterritory entity means—\n(a) an administrative unit; or\n(b) a territory entity under the Auditor-General Act 1996.\n\nEvidentiary provisions Part 11.2\n","sortOrder":193},{"sectionNumber":"178","sectionType":"section","heading":"Evidence—authorisations under Commonwealth and","content":"178 Evidence—authorisations under Commonwealth and\nState laws\n(1) This section applies to the prosecution of a person for an offence\nagainst chapter 4 (Offences relating to regulated substances) or\nchapter 5 (Offences relating to regulated therapeutic goods) if, to\nprove the offence, it is necessary to prove that at a particular time the\nperson was not authorised to deal with a regulated substance or\ntherapeutic good in a particular way.\n(2) Without evidence to the contrary, the person is taken not to have been\nauthorised under a Commonwealth or State law to deal with the\nregulated substance or regulated therapeutic good in that way at the\nparticular time.\n(3) To remove any doubt, a reference in subsection (2) to a State law does\nnot include a territory law.\n","sortOrder":194},{"sectionNumber":"179","sectionType":"section","heading":"Presumptions","content":"179 Presumptions\nIn a proceeding for an offence against this Act, it is presumed until\nthe contrary is proved on the balance of probabilities, that—\n(a) a regulated substance or regulated therapeutic good that is part\nof a batch, lot or consignment of the substance of the same kind\nor description is representative of all the substance or good in\nthe batch, lot or consignment; and\n(b) each part of a sample of a regulated substance divided for\nanalysis for this Act is of uniform composition with every other\npart of the sample; and\n(c) a person manufactured, packed or supplied a regulated\nsubstance or regulated therapeutic good if the person appears to\nhave done so from any marking or label on an article, container\nor package containing the substance or therapeutic good for sale;\nand\n\n(d) a thing that is labelled with the name of—\n(i) a regulated substance is the regulated substance; and\n(ii) a regulated therapeutic good is the regulated therapeutic\n","sortOrder":195},{"sectionNumber":"180","sectionType":"section","heading":"Certificate evidence etc","content":"180 Certificate evidence etc\n(1) This section applies in relation to a proceeding for an offence against\nthis Act.\n(2) A document that appears to be a copy of a licence, authorisation or\napproval under this Act is evidence of the issue or giving of a licence,\nauthorisation or approval.\n(3) A certificate that appears to be signed by or on behalf of the chief\nhealth officer, and that states any of the following matters, is evidence\nof the matters:\n(a) that there was, or was not, in force a licence, authorisation or\napproval in relation to a stated person or premises;\n(b) that a licence, authorisation or approval authorised or required\nor did not authorise or require a stated dealing at a particular\ntime and place;\n(c) that a licence, authorisation or approval was or was not subject\nto stated conditions;\n(d) that a substance is or is not a regulated substance;\n(e) that a regulated substance belongs to or does not belong to a\nparticular kind of regulated substances;\n(f) a thing is or is not a regulated therapeutic good;\n(g) the receipt or otherwise of a notice, application or payment;\n\nEvidentiary provisions Part 11.2\n(h) that an amount of fees or another amount is or was payable under\nthis Act by a stated person.\nNote For evidentiary certificates by authorised analysts, see the Public Health\nAct 1997, s 135A.\n(4) A certificate that appears to be signed by or on behalf of the chief\nhealth officer, and states anything prescribed by regulation, is\nevidence of the thing.\n(5) A certificate mentioned in subsection (3) or subsection (4) may state\nanything by reference to a date or period.\n(6) A court must accept a certificate or other document mentioned in this\nsection as proof of the matters stated in it if there is no evidence to\nthe contrary.\n","sortOrder":196},{"sectionNumber":"181","sectionType":"section","heading":"Admissibility of analysis of samples taken by inspectors","content":"181 Admissibility of analysis of samples taken by inspectors\nThe analysis of a sample of a substance taken by a medicines and\npoisons inspector is admissible in evidence in a proceeding for an\noffence against this Act only if the sample was taken as required or\nallowed under part 7.2 (Taking and analysis of samples of\nsubstances).\n","sortOrder":197},{"sectionNumber":"182","sectionType":"section","heading":"Power of court to order further analysis","content":"182 Power of court to order further analysis\n(1) This section applies if the court before which a person is being\nprosecuted for an offence against this Act is satisfied that there is a\ndisagreement between the evidence of the analysts for the parties to\nthe proceeding.\n(2) The court may order that the part of a sample kept for comparison\nunder section 135 (Procedures for dividing samples) be sent by the\nchief health officer to an independent analyst.\n(3) For subsection (2), the order may require the sample to be sent to a\nparticular analyst or to an analyst agreed to by the parties.\n\n(4) An analysis of a sample under this section is for the information of\nthe court.\n(5) Subject to section 175 (Court may order costs and expenses), the cost\nof an analysis under this section is payable by the Territory.\n\nChapter 12 Regulations about regulated\nsubstances and regulated\n183 Meaning of regulated thing—ch 12\nregulated thing means a regulated substance or regulated therapeutic\n184 Regulation-making power\n(1) The Executive may make regulations for this Act.\n(2) A regulation may create offences and fix maximum penalties of not\nmore than 30 penalty units for the offences.\n","sortOrder":198},{"sectionNumber":"185","sectionType":"section","heading":"Regulations—regulated things","content":"185 Regulations—regulated things\n(1) A regulation may make provision in relation to regulated things,\nincluding, for example—\n(a) the methods and equipment for examining and testing things to\ndecide whether they are regulated things; and\n(b) the methods and equipment for classifying regulated things; and\n(c) the storage and display, including requirements about security\nand accessibility, of regulated things; and\n(d) the advertising and supply of regulated things; and\n(e) the safe dealing with regulated things; and\n(f) the use of regulated things; and\n(g) the authorisation, control, notification and prohibition of\ndealings with regulated things; and\n\n","sortOrder":199},{"sectionNumber":"Part 12","sectionType":"part","heading":"Regulations about regulated substances and regulated therapeutic","content":"Chapter 12 Regulations about regulated substances and regulated therapeutic\n(h) the plant, premises and systems for dealing with regulated\nthings; and\n(i) the security requirements for premises used to deal with\nregulated things; and\n(j) the packing, marking, labelling and packaging of regulated\nthings, including the maximum sizes and packages of regulated\nthings; and\n(k) the making and keeping of records in relation to regulated things\n(including plant and premises for dealing with regulated things)\nand their inspection and auditing.\n(2) A regulation may also make provision in relation to regulated things,\nand other things, that can be used to manufacture regulated things.\n","sortOrder":200},{"sectionNumber":"186","sectionType":"section","heading":"Regulations—authorisations","content":"186 Regulations—authorisations\n(1) A regulation may make provision in relation to authorisations for\ndealing with regulated things, including, for example—\n(a) the circumstances in which an authorisation is required for\ndealing with, or doing something else in relation to, regulated\nthings, including the kind of regulated thing, the kind of\ndealings, the circumstances of the dealings and the amount that\nmay be dealt with; and\n(b) the requirements for an application for an authorisation; and\n(c) the suitability of people to hold an authorisation to deal with\nregulated things, including—\n(i) the knowledge, experience and training of people; and\n(ii) the testing or examination of people to decide whether they\nare, or continue to be, suitable people to hold an\nauthorisation; and\n(d) the circumstances in which authorisations may or must not be\ngiven; and\n\n(e) the suitability of premises (including vehicles) in relation to\ndealings with regulated things; and\n(f) the supervision of dealings with regulated things; and\n(g) the authorisations that may be issued and the authority given to\npeople by particular authorisations; and\n(h) the conditions of authorisations; and\n(i) the creation and publication of registers in relation to\nauthorisations; and\n(j) authorising people to deal with regulated things for research,\neducation or any other purpose.\nExamples of conditions—par (h)\n1 how dispensed medicines are to be labelled\n2 the recording of the supply of regulated things\n3 the packaging of dangerous poisons\n4 how long documents relating to dealings with regulated things must be kept\n(2) A regulation may also make provision in relation to the recognition\nof authorisations (however described) under corresponding laws and\nthe circumstances in which an authorisation to deal with a regulated\nthing under a corresponding law authorises people to deal with the\nregulated thing in the ACT.\n","sortOrder":201},{"sectionNumber":"187","sectionType":"section","heading":"Regulations—records kept electronically","content":"187 Regulations—records kept electronically\n(1) If a document that is required to be kept under this Act is kept in\nelectronic form, a regulation may require that the electronic form of\nthe document be recorded or retained on a particular kind of data\nstorage device.\n(2) Subsection (1) applies despite the Electronic Transactions Act 2001,\nsection 11 (1) (c) and (2) (d) (Retention of information and\ndocuments).\nNote Section 11 (1) (c) and (2) (d) provide for regulations under the Electronic\nTransactions Act 2001 to prescribe data storage devices.\n\nChapter 12 Regulations about regulated substances and regulated therapeutic\n(3) For the Electronic Transactions Act 2001, a regulation under\nsubsection (1) is taken to be a regulation under that Act.\ndata storage device—see the Electronic Transactions Act 2001,\ndictionary.\n","sortOrder":202},{"sectionNumber":"188","sectionType":"section","heading":"Regulations—medicines advisory committee","content":"188 Regulations—medicines advisory committee\nA regulation may make provision in relation to the appointment of\nmembers to, and the procedures of, the medicines advisory\ncommittee.\nNote The committee is established under s 194.\n","sortOrder":203},{"sectionNumber":"189","sectionType":"section","heading":"Regulations—application etc of instruments","content":"189 Regulations—application etc of instruments\n(1) A regulation may apply, adopt or incorporate a law of another\njurisdiction or an instrument, or a provision of a law of another\njurisdiction or instrument, as in force from time to time.\nNote The text of an applied, adopted or incorporated law or instrument,\nwhether applied as in force from time to time or at a particular time, is\ntaken to be a notifiable instrument if the operation of the Legislation Act,\ns 47 (5) or (6) is not disapplied (see s 47 (7)).\nlaw of another jurisdiction—see the Legislation Act, section 47 (10).\n","sortOrder":204},{"sectionNumber":"190","sectionType":"section","heading":"Regulations—exemption of people, dealings etc","content":"190 Regulations—exemption of people, dealings etc\n(1) A regulation may—\n(a) exempt a person, regulated thing, premises or dealing with a\nregulated thing, or anything else, prescribed by regulation from\nthis Act; or\n\n(b) authorise the Minister to exempt a person, regulated thing,\npremises or dealing with a regulated thing, or anything else,\nprescribed by regulation from this Act.\nNote A reference to an Act includes a reference to a provision of an Act (see\nLegislation Act, s 7 (3)).\n(2) An exemption under subsection (1) may be conditional.\n(3) A regulation may provide for the Minister to suspend the operation\nof—\n(a) a regulation mentioned in subsection (1) (a) in the way and\ncircumstances prescribed by regulation; or\n(b) an exemption given under subsection (1) (b) in the way and\ncircumstances prescribed by regulation.\n(4) An exemption under subsection (1) (b) is a disallowable instrument.\n\n","sortOrder":205},{"sectionNumber":"191","sectionType":"section","heading":"Directions about dealings with regulated substances and","content":"191 Directions about dealings with regulated substances and\n(1) For this Act, the chief health officer may give a direction about\ndealing with a regulated substance or regulated therapeutic good to a\nperson who is authorised to deal with the substance or good.\n(2) Without limiting subsection (1), the chief health officer may give a\ndirection that the chief health officer considers necessary for any of\nthe following:\n(a) discarding a regulated substance or regulated therapeutic good;\n(b) safe dealing with a regulated substance or regulated therapeutic\ngood;\n(c) ensuring compliance with any requirement under this Act or any\nother territory law in relation to a regulated substance or\nregulated therapeutic good.\n(3) A direction may be given orally or in writing.\n(4) A direction under subsection (2) (a)—\n(a) must state a reasonable period within which the regulated\nsubstance or regulated therapeutic good must be discarded; and\n(b) may include requirements for the storage of the substance or\ngood until discarded.\n\nMiscellaneous Chapter 13\n","sortOrder":206},{"sectionNumber":"192","sectionType":"section","heading":"Guidelines about dealings with regulated substances and","content":"192 Guidelines about dealings with regulated substances and\n(1) The chief health officer may issue guidelines about dealings with\nregulated substances and regulated therapeutic goods.\n(2) Without limiting subsection (1), a guideline may make provision\nabout the circumstances in which a regulated substance or regulated\ntherapeutic good may be dealt with.\n(3) A guideline is a notifiable instrument.\n","sortOrder":207},{"sectionNumber":"193","sectionType":"section","heading":"Approval of non-standard packaging and labelling","content":"193 Approval of non-standard packaging and labelling\n(1) The chief health officer may approve the packaging or labelling of a\nregulated substance that does not comply with the medicines and\npoisons standard if satisfied that the use of the packaging or labelling\nis as safe as using the packaging or labelling allowed under the\nstandard for the substance.\n(2) The chief health officer may approve a form of packaging or labelling\nfor a regulated therapeutic good if satisfied that the use of the\npackaging or labelling is safe.\n(3) An approval may be conditional.\n(4) An approval is a notifiable instrument.\n","sortOrder":208},{"sectionNumber":"194","sectionType":"section","heading":"Establishment of medicines advisory committee","content":"194 Establishment of medicines advisory committee\nThe Medicines Advisory Committee is established.\n","sortOrder":209},{"sectionNumber":"195","sectionType":"section","heading":"Secrecy","content":"195 Secrecy\ncourt includes any tribunal or other entity having power to require the\nproduction of documents or the answering of questions.\nproduce includes permit access to.\n\nprotected information means information about a person that is\ndisclosed to, or obtained by, a person to whom this section applies\nbecause of the exercise of a function under this Act.\n(2) This section applies to—\n(a) a person who is or has been a member of the medicines advisory\ncommittee; or\n(b) anyone else who has exercised, or purported to exercise, a\nfunction under this Act.\n(3) A person to whom this section applies commits an offence if the\nperson—\n(a) makes a record of protected information; or\n(b) directly or indirectly discloses or communicates to a person\nprotected information about someone else.\n(4) Subsection (3) does not apply if the record is made, or the information\nis disclosed or communicated—\n(a) under this or any other Act; or\n(b) in relation to the exercise of a function of the person to whom\nthis section applies under this or any other Act; or\n(c) about a person if the giving of the information is necessary to\nremove a threat to the life or health of the person; or\n(d) to a person administering or enforcing a corresponding law; or\n(e) to a law enforcement authority; or\n(f) to a national board under the Health Practitioner Regulation\nNational Law (ACT) or the veterinary practitioners board; or\n\nMiscellaneous Chapter 13\n(g) to a court under a summons or subpoena.\n(5) Subsection (3) does not prevent a person to whom this section applies\nfrom communicating protected information to a person about\nsomeone else with the consent of the other person.\n","sortOrder":210},{"sectionNumber":"196","sectionType":"section","heading":"Protection of officials from liability","content":"196 Protection of officials from liability\nofficial means—\n(a) a member of the medicines advisory committee; or\n(b) anyone else who exercises a function under this Act.\n(2) An official, or anyone engaging in conduct under the direction of an\nofficial, is not personally liable for anything done or omitted to be\ndone honestly and without recklessness—\n(a) in the exercise of a function under this Act; or\n(b) in the reasonable belief that the conduct was in the exercise of a\nfunction under this Act.\n(3) Any civil liability that would, apart from subsection (2), attach to an\nofficial attaches instead to the Territory.\n","sortOrder":211},{"sectionNumber":"197","sectionType":"section","heading":"Determination of fees","content":"197 Determination of fees\n(1) The Minister may determine fees for this Act.\n(2) A determination is a disallowable instrument.\n\n(see ch 9)\nitem\n1 85 issue licence for less than\nmaximum period\napplicant for licence\n2 85 (2) refuse to issue licence applicant for licence\n3 90 (1) issue licence subject to condition\nincluded by chief health officer\napplicant for licence\n4 91 amend licence licence-holder\n5 92 amend licence in terms different\nfrom application or refuse to\namend licence\nlicence-holder\n6 142 (3) • reprimand authorisation\nholder\n• require authorisation holder\nor employee to complete\ntraining\n• impose condition on\nauthorisation holder’s\nauthority to deal with\n• amend authorisation\nauthorisation holder\n\nReviewable decisions Schedule 1\nitem\n• suspend authorisation\ntherapeutic good or deal\ntherapeutic good in\nparticular way\n• period of suspension/course\nof training/stated event\n• cancel authorisation\n• prohibit interstate\nwholesaler from supplying\ntherapeutic good by\nwholesale in ACT\n7 142 (3) • reprimand former\nauthorisation holder\n• disqualify former\nauthorisation holder from\nbeing authorised to deal\ntherapeutic good or deal\ntherapeutic good in\nparticular way\n• period of\ndisqualification/course of\ntraining/stated event\nformer authorisation\nholder\n\nitem\n• prohibit former interstate\nwholesaler from supplying\ntherapeutic good by\nwholesale in ACT\n8 191 give direction person to whom\ndirection is given\n\n(see s 3)\nNote 1 The Legislation Act contains definitions and other provisions relevant to\nthis Act.\nNote 2 For example, the Legislation Act, dict, pt 1, defines the following terms:\n• ACAT\n• bankrupt or personally insolvent\n• chief health officer\n• contravene\n• corporation\n• dentist\n• doctor\n• found guilty\n• function\n• health practitioner\n• home address\n• midwife\n• Minister (see s 162)\n• optometrist\n• pharmacist\n• reviewable decision notice\n• territory-owned corporation\n• under\n• veterinary practitioner.\nanother jurisdiction, for chapter 6A (Monitored medicines\napplied provisions, for chapter 10 (Incorporation of Commonwealth\ntherapeutic goods laws)—see section 156.\napplies, in relation to a substance for a schedule or appendix of the\nmedicines and poisons standard—see section 17.\n\napproved data source entity, for chapter 6A (Monitored medicines\nat premises includes in or on the premises.\nauthorisation holder, for part 8.1 (Authorisations—disciplinary\naction)—see section 139.\nauthorised—\n(a) to deal with a regulated substance—see section 20; and\n(b) to deal with a regulated therapeutic good—see section 22.\nbusiness includes—\n(a) a business not carried on for profit; and\n(b) a trade or profession.\nclose associate, of someone, for chapter 6 (Licences for regulated\nsubstances and regulated therapeutic goods)—see section 79.\nCommonwealth administrative laws, for chapter 10 (Incorporation\nof Commonwealth therapeutic goods laws)—see section 156.\nCommonwealth Minister, for chapter 10 (Incorporation of\nCommonwealth therapeutic goods laws)—see section 156.\nCommonwealth Secretary, for chapter 10 (Incorporation of\nCommonwealth therapeutic goods laws)—see section 156.\nCommonwealth therapeutic goods laws, for chapter 10\n(Incorporation of Commonwealth therapeutic goods laws)—see\nsection 156.\ncommunity pharmacy means a pharmacy at a place other than an\ninstitution.\nconnected, with an offence, for part 7.1 (Inspection and seizure\npowers)—see section 98.\ncontrolled medicine—see section 11.\n\ncorresponding law means—\n(a) a law of a State corresponding, or substantially corresponding,\nto this Act; or\n(b) a law of the Commonwealth, a State or New Zealand that is\ndeclared by regulation to be a corresponding law, whether or not\nthe law corresponds, or substantially corresponds, to this Act.\nNote State includes a territory (see Legislation Act, dict, pt 1).\ndangerous poison—see section 12.\nday hospital means a facility where a person is admitted for surgical\nor medical treatment and discharged on the same day.\ndeals—\n(a) with a regulated substance—see section 19; and\n(b) with a regulated therapeutic good—see section 21.\ndeclared substance, for part 4.1 (Dealings with regulated\nsubstances—offences)—see section 25.\ndisciplinary action, for part 8.1 (Authorisations—disciplinary\naction)—see section 141.\ndisciplinary notice, for part 8.1 (Authorisations—disciplinary\naction)—see section 142 (1).\ndispense means supply on prescription.\ndosage unit means an individual dose of a medicine or poison for\ntherapeutic use and includes a tablet, capsule, cachet, single-dose\npowders or single-dose sachet or powders or granules.\ndrug offence, for part 8.2 (Controlled medicines and prohibited\nsubstances—disqualification by courts)—see section 147.\nexecutive officer, of a corporation, means a person, however\ndescribed and whether or not the person is a director of the\ncorporation, who is concerned with, or takes part in, the corporation’s\nmanagement.\n\nground for disciplinary action, against an authorisation holder, for\npart 8.1 (Authorisations—disciplinary action)—see section 140 (1).\nhospital—\n(a) means a public hospital, private hospital or day hospital; and\nNote A hospice is a hospital (see The Macquarie Dictionary, 3rd ed,\ndef hospice).\n(b) includes a body prescribed by regulation as a hospital.\ninfluential person, for a corporation, for chapter 6 (Licences for\nregulated substances and regulated therapeutic goods)—see\nsection 80.\ninstitution—\n(a) means a hospital, residential aged care facility, residential\ndisability care facility or other institution used for the\naccommodation, treatment and care of people suffering from\nmental or physical conditions; and\nNote Hospital, residential aged care facility and residential disability\ncare facility are defined in this dictionary.\n(b) includes a body prescribed by regulation as an institution.\ninterstate wholesaler, for part 8.1 (Authorisations—disciplinary\naction)—see section 139.\nlicence, for chapter 6 (Licences for regulated substances and\nregulated therapeutic goods)—see section 78.\nlow harm poison—see section 12.\nmanufacture, for a regulated substance, means do 1 or more of the\nfollowing in relation to the substance:\n(a) carry out a process to produce the substance;\n(b) refine the substance;\n(c) convert the substance into another regulated substance;\n\n(d) make or prepare an ampoule, capsule, tablet, vial or other dosage\nform that consists of, or contains, the substance;\n(e) mix, compound or formulate the substance with another\nregulated substance or any other substance;\n(f) pack or repack the substance for sale by wholesale or for use in\nconnection with a business, industry, profession or trade.\nmedicine—see section 11.\nmedicines advisory committee means the Medicines Advisory\nCommittee established under section 194.\nmedicines and poisons inspector—see section 99.\nmedicines and poisons standard—see section 15.\nmoderate harm poison—see section 12.\nmonitored medicine—see section 97A.\nmonitored medicines database, for chapter 6A (Monitored medicines\nmust keep, a register for a regulated substance, for division 4.2.2\n(Registers for regulated substances)—see section 48.\noccupier, of premises, for part 7.1 (Inspection and seizure powers)—\nsee section 98.\noffence, for part 7.1 (Inspection and seizure powers)—see section 98.\nopioid dependency treatment centre means a facility—\n(a) licensed under this Act to treat opioid dependency; or\n(b) operated by the Territory where treatment, including the supply\nand administration of controlled medicines, is provided to\ndrug-dependent people for their drug dependency.\npharmacist only medicine—see section 11.\npharmacy medicine—see section 11.\n\npoison—see section 12.\npossess, for a regulated substance—see section 24.\npremises includes land or a structure or vehicle and any part of an\narea of land or a structure or vehicle.\nprescribe a medicine means issue a prescription for the medicine.\nprescription, in relation to a medicine, means an oral or written\ndirection (other than a purchase order, requisition or standing order)\nto a person—\n(a) who is authorised to administer the medicine to administer the\nmedicine; or\n(b) who is authorised to dispense the medicine to dispense the\nmedicine.\nprescription only medicine—see section 11.\nprohibited substance—see section 13.\npurchase order means a written order for the supply of a regulated\nregister, for a regulated substance, means a register that a person is\nrequired to keep under section 48 for the substance.\nregulated substance—see section 10.\nregulated therapeutic good—see section 14.\nregulated thing, for chapter 12 (Regulations about regulated\nsubstances and regulated therapeutic goods)—see section 183.\nrelevant health practitioner, for chapter 6A (Monitored medicines\nrelevant person, for part 8.2 (Controlled medicines and prohibited\nsubstances—disqualification by courts)—see section 147.\nrequired information, about the supply of a monitored medicine, for\nchapter 6A (Monitored medicines database)—see section 31 (4).\n\nrequisition means an oral or written request for the supply of a\nmedicine—\n(a) from a pharmacy in an institution to a ward or another pharmacy\nin the institution; or\n(b) to a pharmacy in an institution from a ward in the institution; or\n(c) to a ward in an institution from another ward in the institution;\nor\n(d) from a pharmacy in an institution to a pharmacy in another\ninstitution.\nresidential aged care facility means a residential care home within\nthe meaning of the Aged Care Act 2024 (Cwlth), section 10.\nresidential disability care facility—\n(a) means a residential facility that provides disability care to\npeople with disabilities; but\n(b) does not include a residential aged care facility.\nreviewable decision, for chapter 9 (Notification and review of\ndecisions)—see section 154.\nschedule 10 substance—see section 13.\nsell—see section 24.\nsigns—a person signs something if the person signs with the person’s\nusual signature, whether electronically or otherwise.\nstanding order means a written order authorising the supply or\nadministration of medicines as stated in the order, in stated clinical\ncircumstances.\nsuitable person—\n(a) for an individual—see section 81; and\n(b) for a corporation—see section 82.\nsupply—see section 24.\n\nsupply authority—see section 23.\nvending machine, for division 4.3.5 (Vending machines—\noffences)—see section 67.\nveterinary practitioners board means the veterinary practitioners\nboard established under the Veterinary Practice Act 2018, section 90.\nward means an area of an institution used to accommodate or treat\npeople, including an operating theatre and an opioid dependency\ntreatment centre.\nwholesale means supply—\n(a) for retail sale; or\n(b) for use in connection with a business, industry, profession or\ntrade.\nwritten includes in electronic form.\n\nAbout the endnotes 1\n1 About the endnotes\nAmending and modifying laws are annotated in the legislation history and the\namendment history. Current modifications are not included in the republished law\nbut are set out in the endnotes.\nNot all editorial amendments made under the Legislation Act 2001, part 11.3 are\nannotated in the amendment history. Full details of any amendments can be\nobtained from the Parliamentary Counsel’s Office.\nUncommenced amending laws are not included in the republished law. The details\nof these laws are underlined in the legislation history. Uncommenced expiries are\nunderlined in the legislation history and amendment history.\nIf all the provisions of the law have been renumbered, a table of renumbered\nprovisions gives details of previous and current numbering.\nThe endnotes also include a table of earlier republications.\n2 Abbreviation key\nA = Act NI = Notifiable instrument\nAF = Approved form o = order\nam = amended om = omitted/repealed\namdt = amendment ord = ordinance\nAR = Assembly resolution orig = original\nch = chapter par = paragraph/subparagraph\nCN = Commencement notice pres = present\ndef = definition prev = previous\nDI = Disallowable instrument (prev...) = previously\ndict = dictionary pt = part\ndisallowed = disallowed by the Legislative r = rule/subrule\nAssembly reloc = relocated\ndiv = division renum = renumbered\nexp = expires/expired R[X] = Republication No\nGaz = gazette RI = reissue\nhdg = heading s = section/subsection\nIA = Interpretation Act 1967 sch = schedule\nins = inserted/added sdiv = subdivision\nLA = Legislation Act 2001 SL = Subordinate law\nLR = legislation register sub = substituted\nLRA = Legislation (Republication) Act 1996 underlining = whole or part not commenced\nmod = modified/modification or to be expired\n\nMedicines, Poisons and Therapeutic Goods Act 2008 A2008-26\nnotified LR 14 August 2008\ns 1, s 2 commenced 14 August 2008 (LA s 75 (1))\nremainder commenced 14 February 2009 (s 2 and LA s 79)\nas amended by\nACT Civil and Administrative Tribunal Legislation Amendment\nAct 2008 A2008-36 sch 1 pt 1.37\nnotified LR 4 September 2008\ns 1, s 2 commenced 4 September 2008 (LA s 75 (1))\nsch 1 pt 1.37 commenced 14 February 2009 (s 2 (5) and see A2008-26\ns 2 and LA s 79)\nas modified by\nMedicines, Poisons and Therapeutic Goods Regulation 2008\nSL2008-42 (as am by SL2009-27 s 6)\nnotified LR 15 September 2008\ns 1, s 2 commenced 15 September 2008 (LA s 75 (1))\nremainder commenced 14 February 2009 (s 2 and see Medicines,\nPoisons and Therapeutic Goods Act 2008 A2008-26, s 2 and LA s 79)\nMedicines, Poisons and Therapeutic Goods Amendment\nRegulation 2009 (No 1) SL2009-27 s 6\nnotified LR 5 June 2009\ns 1, s 2 commenced 5 June 2009 (LA s 75 (1))\ns 6 commenced 6 June 2009 (s 2)\nNote This regulation only amends the Medicines, Poisons and\nTherapeutic Goods Regulation 2008 SL2008-42.\nas amended by\nStatute Law Amendment Act 2009 A2009-20 sch 3 pt 3.52\nnotified LR 1 September 2009\ns 1, s 2 commenced 1 September 2009 (LA s 75 (1))\nsch 3 pt 3.52 commenced 22 September 2009 (s 2)\n\nLegislation history 3\nStatute Law Amendment Act 2009 (No 2) A2009-49 sch 1 pt 1.8, sch 3\npt 3.50\nnotified LR 26 November 2009\ns 1, s 2 commenced 26 November 2009 (LA s 75 (1))\nsch 1 pt 1.8, sch 3 pt 3.50 commenced 17 December 2009 (s 2)\nHealth Practitioner Regulation National Law (ACT) Act 2010 A2010-10\nsch 2 pt 2.14\nnotified LR 31 March 2010\ns 1, s 2 commenced 31 March 2010 (LA s 75 (1))\nsch 2 pt 2.14 commenced 1 July 2010 (s 2 (1) (a))\nAdministrative (One ACT Public Service Miscellaneous Amendments)\nAct 2011 A2011-22 sch 1 pt 1.113\nnotified LR 30 June 2011\ns 1, s 2 commenced 30 June 2011 (LA s 75 (1))\nsch 1 pt 1.113 commenced 1 July 2011 (s 2 (1))\nStatute Law Amendment Act 2011 (No 3) A2011-52 sch 1 pt 1.4\nnotified LR 28 November 2011\ns 1, s 2 commenced 28 November 2011 (LA s 75 (1))\nsch 1 pt 1.4 commenced 12 December 2011 (s 2)\nDirectors Liability Legislation Amendment Act 2013 A2013-4 sch 1\npt 1.6\nnotified LR 21 February 2013\ns 1, s 2 commenced 21 February 2013 (LA s 75 (1))\nsch 1 pt 1.6 commenced 22 February 2013 (s 2)\nStatute Law Amendment Act 2013 (No 2) A2013-44 sch 3 pt 3.14\nnotified LR 11 November 2013\ns 1, s 2 commenced 11 November 2013 (LA s 75 (1))\nsch 3 pt 3.14 commenced 25 November 2013 (s 2)\nAnnual Reports (Government Agencies) Amendment Act 2015\nA2015-16 sch 1 pt 1.16\nnotified LR 27 May 2015\ns 1, s 2 commenced 27 May 2015 (LA s 75 (1))\nsch 1 pt 1.16 commenced 3 June 2015 (s 2)\n\nVeterinary Surgeons Act 2015 A2015-29 sch 2 pt 2.9\nnotified LR 20 August 2015\ns 1, s 2 commenced 20 August 2015 (LA s 75 (1))\nsch 2 pt 2.9 commenced 1 December 2015 (s 2 (1) and CN2015-22)\nStatute Law Amendment Act 2015 (No 2) A2015-50 sch 1 pt 1.2\nnotified LR 25 November 2015\ns 1, s 2 commenced 25 November 2015 (LA s 75 (1))\nsch 1 pt 1.2 commenced 9 December 2015 (s 2)\nRed Tape Reduction Legislation Amendment Act 2016 A2016-18\nsch 3 pt 3.30\nnotified LR 13 April 2016\ns 1, s 2 commenced 13 April 2016 (LA s 75 (1))\nsch 3 pt 3.30 commenced 27 April 2016 (s 2)\nJustice and Community Safety Legislation Amendment Act 2016\nA2016-37 sch 1 pt 1.15\nnotified LR 22 June 2016\ns 1, s 2 commenced 22 June 2016 (LA s 75 (1))\nsch 1 pt 1.15 commenced 29 June 2016 (s 2)\nWork Health and Safety Legislation Amendment Act 2018 A2018-8\nsch 1 pt 1.6\nnotified LR 5 March 2018\ns 1, s 2 commenced 5 March 2018 (LA s 75 (1))\nsch 1 pt 1.6 commenced 29 March 2018 (s 2)\nMedicines, Poisons and Therapeutic Goods Amendment Act 2018\nA2018-23 pt 2\nnotified LR 14 June 2018\ns 1, s 2 commenced 14 June 2018 (LA s 75 (1))\npt 2 commenced 15 June 2018 (s 2)\nVeterinary Practice Act 2018 A2018-32 sch 3 pt 3.11\nnotified LR 30 August 2018\ns 1, s 2 commenced 30 August 2018 (LA s 75 (1))\nsch 3 pt 3.11 commenced 21 December 2018 (s 2 and CN2018-12)\n\nLegislation history 3\nRed Tape Reduction Legislation Amendment Act 2018 A2018-33\nsch 1 pt 1.25\nnotified LR 25 September 2018\ns 1, s 2 commenced 25 September 2018 (LA s 75 (1))\nsch 1 pt 1.25 commenced 23 October 2018 (s 2 (4))\nCrimes Legislation Amendment Act 2019 A2019-23 pt 11\nnotified LR 8 August 2019\ns 1, s 2 commenced 8 August 2019 (LA s 75 (1))\npt 11 commenced 15 August 2019 (s 2 (1))\nDrugs of Dependence (Personal Cannabis Use) Amendment Act 2019\nA2019-34 sch 1 pt 1.2\nnotified LR 10 October 2019\ns 1, s 2 commenced 10 October 2019 (LA s 75 (1))\nsch 1 pt 1.2 commenced 31 January 2020 (s 2 (1) and CN2020-1))\nStatute Law Amendment Act 2021 A2021-12 sch 3 pt 3.35\nnotified LR 9 June 2021\ns 1, s 2 commenced 9 June 2021 (LA s 75 (1))\nsch 3 pt 3.35 commenced 23 June 2021 (s 2 (1))\nHealth Legislation Amendment Act 2022 A2022-24 pt 2\nnotified LR 9 December 2022\ns 1, s 2 commenced 9 December 2022 (LA s 75 (1))\npt 2 commenced 10 December 2022 (s 2)\nVoluntary Assisted Dying Act 2024 A2024-24 sch 3 pt 3.5\nnotified LR 19 June 2024\ns 1, s 2 commenced 19 June 2024 (LA s 75 (1))\nsch 3 pt 3.5 commenced 3 November 2025 (s 2)\nHealth Legislation Amendment Act 2024 A2024-42 pt 5\nnotified LR 17 September 2024\ns 1, s 2 commenced 17 September 2024 (LA s 75 (1))\npt 5 commenced 18 September 2024 (s 2 (1))\nTobacco and Other Smoking Products (Vaping Goods) Amendment\nAct 2025 A2025-8 sch 2 pt 2.1\nnotified LR 17 April 2025\ns 1, s 2 commenced 17 April 2025 (LA s 75 (1))\nsch 2 pt 2.1 commenced 18 April 2025 (s 2)\n\nHealth Legislation Amendment Act 2025 A2025-16 sch 1 pt 1.5\nnotified LR 26 May 2025\ns 1, s 2 commenced 26 May 2025 (LA s 75 (1))\nsch 1 pt 1.5 commenced 2 June 2025 (s 2)\nStatute Law Amendment Act 2025 A2025-29 sch 3 pt 3.62, sch 4\npt 4.124\nnotified LR 6 November 2025\ns 1, s 2 commenced 6 November 2025 (LA s 75 (1))\nsch 3 pt 3.62, sch 4 pt 4.124 commenced 26 November 2025 (s 2 (3),\n(9))\nHealth Legislation Amendment Act 2025 (No 2) A2025-33 pt 4\nnotified LR 12 November 2025\ns 1, s 2 commenced 12 November 2025 (LA s 75 (1))\npt 4 commenced 26 November 2025 (s 2 (1) (a), (3))\n\nCommencement\ns 2 om LA s 89 (4)\ns 3 am A2015-29 amdt 2.63\nObjects\ns 6 am A2010-10 amdt 2.79; A2015-29 amdt 2.64; A2018-32\namdt 3.29\nAppropriate prescription and supply of medicines\ns 7 am A2010-10 amdt 2.80; A2015-29 amdt 2.65; A2018-32\namdt 3.30\nApplication of Act to certain cannabis use not prohibited under Drugs of\nDependence Act 1989\ns 9A ins A2019-34 amdt 1.3\nMeaning of regulated substance—Act\ns 10 am A2015-50 amdt 1.9\nMeaning of prohibited substance and schedule 10 substance—Act\ns 13 sub A2015-50 amdt 1.4\nam A2019-23 s 51, s 52\nMeaning of regulated therapeutic good—Act\ns 14 am A2025-8 amdt 2.1\nMeaning of medicines and poisons standard—Act\ns 15 am A2025-8 amdt 2.2, amdt 2.3\nInterpretation provisions in medicines and poisons standard—application to\nAct\ns 16 am A2025-33 s 7, s 8\nMeaning of deals with a regulated substance—Act\ns 19 am A2015-50 amdt 1.9\nWhen authorised to deal with regulated substances\ns 20 am A2015-50 amdt 1.9; A2024-24 amdt 3.8; A2025-33 s 9\nMeaning of possess, sell and supply—Act\ns 24 am A2009-49 amdt 3.118\nMeaning of declared substance—pt 4.1\ns 25 am A2015-50 amdt 1.9\nSupplying declared substances\ns 26 am A2025-29 amdt 3.205\nSupply of certain declared substances—information for chief health officer\ns 31 am A2018-23 s 4\n\nDiscarding declared etc substances\ns 34 am A2018-8 amdt 1.25, amdt 1.26\nAdministering certain declared substances\ns 37 am A2016-37 amdt 1.31; ss renum R16 LA; A2025-29\namdt 3.205\nReporting loss and theft of certain regulated substances\ns 39 am A2015-50 amdt 1.9\nPrescribing medicines\ns 40 am A2025-29 amdt 3.205\nMedicines for animals not to be prescribed etc for human use\ns 43 am R29 LA\nFalse statements to obtain certain regulated substances etc\ns 64 am A2009-49 amdt 3.119\nAdvertising controlled medicines and prohibited substances\ns 66 am A2018-32 amdt 3.31\nVending machines—use for supply of unscheduled medicines\ns 69 am A2025-33 s 10\nPaints—offences\ndiv 4.3.6 hdg am A2025-33 s 10\nManufacture, supply and use of paints for certain purposes\ns 71 am A2015-50 amdt 1.5, amdt 1.6; A2025-33 s 10\nManufacture, supply and use of paints containing pesticides\ns 73 am A2025-33 s 10\nSupplying regulated therapeutic goods\ns 74 am A2016-37 amdt 1.32, amdt 1.33; ss renum R16 LA;\nA2025-29 amdt 3.207\nSuitability of individuals for licences\ns 81 am A2009-20 amdt 3.132; A2011-52 amdt 1.6\nPower to ask for information etc from applicants and others\ns 83 am A2009-20 amdt 3.133; A2013-44 amdt 3.105; A2016-18\namdts 3.144-3.146\nApplications for licences\ns 84 am A2021-12 amdt 3.83; A2025-29 amdt 4.125\nDecision on applications for licences\ns 85 am A2009-20 amdt 3.134; A2021-12 amdt 3.84\nForm of licences\ns 88 am A2009-20 amdt 3.135; A2009-49 amdt 1.21\n\nStatutory licence conditions\ns 89 am A2009-20 amdt 3.136\nOther licence conditions\ns 90 am A2009-20 amdt 3.137\nAmending licence on application by licence-holder\ns 92 am A2021-12 amdt 3.85; A2025-29 amdt 4.125\nLicensee to keep chief health officer informed\ns 93 hdg sub A2009-49 amdt 1.22\ns 93 am A2009-49 amdt 1.22\nReplacing licences\ns 95 am A2013-44 amdt 3.106; A2016-18 amdt 3.147, amdt 3.148;\nA2025-29 amdt 4.125\nSurrendering licences\ns 97 am A2013-44 amdt 3.107; A2016-18 amdt 3.149, amdt 3.150\nMonitored medicines database\nch 6A hdg ins A2018-23 s 5\nMeaning of monitored medicine\ns 97A ins A2018-23 s 5\nDefinitions—ch 6A\ns 97B ins A2018-23 s 5\ndef another jurisdiction ins A2018-23 s 5\nsub A2024-42 s 10\ndef approved data source entity ins A2018-23 s 5\ndef monitored medicines database ins A2018-23 s 5\ndef relevant health practitioner ins A2018-23 s 5\ndef required information ins A2018-23 s 5\nMonitored medicines database—purposes\ns 97C ins A2018-23 s 5\nMonitored medicines database—scope\ns 97D ins A2018-23 s 5\nMonitored medicines database—chief health officer functions\ns 97E ins A2018-23 s 5\nMonitored medicines database—access and use by relevant health\npractitioners\ns 97F ins A2018-23 s 5\nMonitored medicines database—access authority\ns 97G ins A2018-23 s 5\nam A2021-12 amdt 3.85; A2025-29 amdt 4.125\n\nMonitored medicines database—offences\ns 97H ins A2018-23 s 5\nPower to enter premises\ns 102 am A2009-20 amdt 3.138; pars renum R3 LA\nProduction of identity card\ns 103 am A2025-29 amdt 3.208\nConsent to entry\ns 104 am A2025-29 amdt 3.208\nPower to require name and address\ns 108 am A2025-8 amdt 2.4\nWarrants—application made other than in person\ns 110 am A2018-33 amdt 1.47, amdt 1.48\nSearch warrants—announcement before entry\ns 111 am A2025-29 amdt 3.209\nProcedures for dividing samples\ns 135 am A2009-20 amdt 3.139\nCertificates of analysis by authorised analysts\ns 137 am A2021-12 amdt 3.85\nApplication—pt 8.1\ns 138 am A2010-10 amdt 2.81; A2015-29 amdt 2.66; A2018-32\namdt 3.32\nDisciplinary action against authorisation holders\ns 141 am A2018-23 s 6, s 7\nTaking disciplinary action against authorisation holders\ns 142 am A2025-29 amdt 3.210\nEffect of suspension of authorisations\ns 144 am A2018-23 s 8\nReturn of certain licences and approvals\ns 145 am A2018-23 s 8, s 9\nAction by chief health officer in relation to certain licences and approvals\ns 146 am A2018-23 s 10\nNotice of disqualification from dealing\ns 149 am A2010-10 amdt 2.82; A2015-29 amdt 2.67; A2018-32\namdt 3.33\nSurrender of authorisation under regulation\ns 152 am A2010-10 amdt 2.82; A2015-29 amdt 2.68; A2018-32\namdt 3.33\n\nNotification and review of decisions\nch 9 hdg sub A2008-36 amdt 1.491\nMeaning of reviewable decision—ch 9\ns 154 sub A2008-36 amdt 1.491\nReviewable decision notices\ns 155 sub A2008-36 amdt 1.491\nApplications for review\ns 155A ins A2008-36 amdt 1.491\nDefinitions—ch 10\ns 156 def Commonwealth administrative laws am A2025-16\namdt 1.32\nApplication of Commonwealth therapeutic goods laws to ACT\ns 157 am A2022-24 s 4\nCriminal liability of executive officers\ns 172 sub A2013-4 amdt 1.7\nam A2025-29 amdt 3.211\nNotices of noncompliance by territory entities\ns 177 am A2011-22 amdts 1.331-1.333; A2015-16 amdt 1.20,\namdt 1.21; ss renum R12 LA; A2025-29 amdt 3.212\nRegulation-making power\ns 184 am A2025-29 amdt 4.125\nRegulations—authorisations\ns 186 am A2009-20 amdt 3.140\nRegulations—application etc of instruments\ns 189 am A2025-29 amdt 4.125\nRegulations—exemption of people, dealings etc\ns 190 am A2013-44 amdt 3.108; A2025-29 amdt 4.125\nGuidelines about dealings with regulated substances and therapeutic goods\ns 192 am A2025-29 amdt 4.125\nApproval of non-standard packaging and labelling\ns 193 am A2025-29 amdt 4.125\nSecrecy\ns 195 am A2010-10 amdt 2.83; A2015-29 amdt 2.69; A2018-32\namdt 3.34\nDetermination of fees\ns 197 am A2025-29 amdt 4.125\n\nApproved forms\ns 198 om A2021-12 amdt 3.86\nTransitional\nch 14 hdg exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—general\npt 14.1 hdg exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nDefinitions—ch 14\ns 500 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional regulations\ns 501 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional effect—Legislation Act, s 88\ns 502 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nExpiry—ch 14\ns 503 exp 14 February 2011 (s 503)\nConsequential and other amendments and repeals\npt 14.2 hdg om LA s 89 (3)\nLegislation amended—sch 2\ns 510 om LA s 89 (3)\nLegislation repealed\ns 511 om LA s 89 (3)\nTransitional—licences and authorisations\npt 14.3 hdg exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—existing licences\ns 520 am A2009-20 amdt 3.141\nTransitional—uncompleted licence applications\ns 521 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—existing authorisations\ns 522 am A2009-20 amdt 3.141\nTransitional—uncompleted authorisation applications\ns 523 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—uncompleted applications for ACAT review\ns 524 sub A2008-36 amdt 1.492\nTransitional—approvals to prescribe drugs of dependence\npt 14.4 hdg exp 14 February 2011 (s 503 (LA s 88 declaration applies)))\n\nTransitional—meaning of drugs advisory committee—pt 14.4\ns 530 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—existing approvals to prescribe drugs of dependence\ns 531 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—uncompleted applications to prescribe drugs of dependence\ns 532 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—uncompleted applications for drugs advisory committee\nreview\ns 533 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—supply authorities\npt 14.5 hdg exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—prescriptions generally\ns 540 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—requisitions generally\ns 541 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—purchase orders generally\ns 542 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—standing orders\ns 543 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—other\npt 14.6 hdg exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—registers\ns 550 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nTransitional—drugs advisory committee members\ns 551 exp 14 February 2011 (s 503 (LA s 88 declaration applies))\nModification—Crimes Act 1900\ns 552 ins as mod SL2008-42 s 1100 (as ins by SL2009-27 s 6)\nmod lapsed 21 December 2010 (SL2008-42 s 1100 om by\nA2010-50 amdt 1.13)\nReviewable decisions\nsch 1 sub A2008-36 amdt 1.493\nam A2018-23 s 11\nConsequential and other amendments\nsch 2 om LA s 89 (3)\n\ndict am A2008-36 amdt 1.494; A2009-49 amdt 3.120; A2010-10\namdt 2.84; A2011-52 amdt 1.7; A2013-44 amdt 3.109;\nA2015-29 amdt 2.70; A2018-32 amdt 3.35; A2025-29\namdt 3.213\ndef another jurisdiction ins A2018-23 s 12\ndef appendix C substance om A2015-50 amdt 1.7\ndef approved data source entity ins A2018-23 s 12\ndef chief pharmacist reloc to Medicines, Poisons and\nTherapeutic Goods Regulation 2008 dict by A2013-44\namdt 3.110\ndef declared substance am A2013-44 amdt 3.111\ndef drug-dependent person reloc to Medicines, Poisons and\nTherapeutic Goods Regulation 2008 dict by A2013-44\namdt 3.112\ndef health professional om A2015-29 amdt 2.71\ndef medicines advisory committee am A2013-44 amdt 3.113\ndef monitored medicine ins A2018-23 s 12\ndef monitored medicines database ins A2018-23 s 12\ndef prescribe sub A2013-44 amdt 3.114\ndef relevant health practitioner ins A2018-23 s 12\ndef required information ins A2018-23 s 12\ndef residential aged care facility sub A2025-33 s 11\ndef reviewable decision ins A2008-36 amdt 1.495\ndef schedule 10 substance ins A2015-50 amdt 1.8\ndef vending machine am A2013-44 amdt 3.115\ndef veterinary practitioners board ins A2018-32 amdt 3.36\ndef veterinary surgeons board ins A2015-29 amdt 2.72\nom A2018-32 amdt 3.37\n\nEarlier republications 5\n5 Earlier republications\nSome earlier republications were not numbered. The number in column 1 refers to\nthe publication order.\nSince 12 September 2001 every authorised republication has been published in\nelectronic pdf format on the ACT legislation register. A selection of authorised\nrepublications have also been published in printed format. These republications are\nmarked with an asterisk (*) in column 1. Electronic and printed versions of an\nauthorised republication are identical.\nfor\n14 Feb 2009\n14 Feb 2009–\nA2008-36 new Act and\namendments by\nA2008-36\n6 June 2009–\n21 Sept 2009\nSL2009-27 modifications by\nSL2008-42 as\namended by\nSL2009-27\n22 Sept 2009\n22 Sept 2009–\n16 Dec 2009\nA2009-20 amendments by\nA2009-20\n17 Dec 2009\n17 Dec 2009–\nA2009-49 amendments by\nA2009-49\n1 July 2010–\n20 Dec 2010\nA2010-10 amendments by\nA2010-10\n21 Dec 2010\n21 Dec 2010–\n14 Feb 2011\nA2010-10 lapsed modification\n(s 552)\n15 Feb 2011\n15 Feb 2011–\nA2010-10 expiry of\ntransitional\nprovisions (ch 14)\n1 July 2011–\n11 Dec 2011\nA2011-22 amendments by\nA2011-22\n12 Dec 2011\n12 Dec 2011–\n21 Feb 2013\nA2011-52 amendments by\nA2011-52\n22 Feb 2013\n22 Feb 2013–\n24 Nov 2013\nA2013-4 amendments by\nA2013-4\n\n5 Earlier republications\nfor\n25 Nov 2013\n","sortOrder":212},{"sectionNumber":"25","sectionType":"section","heading":"No 2013–","content":"25 No 2013–\nA2013-44 relocation of\nprovisions to\nSL2008-40 and\nother amendments\nby A2013-44\n3 June 2015–\n30 Nov 2015\nA2015-16 amendments by\nA2015-16\n1 Dec 2015\n1 Dec 2015–\n8 Dec 2015\nA2015-29 amendments by\nA2015-29\n9 Dec 2015\n9 Dec 2015–\n26 Apr 2016\nA2015-50 amendments by\nA2015-50\n27 Apr 2016\n27 Apr 2016–\nA2016-18 amendments by\nA2016-18\n29 June 2016–\n28 Mar 2018\nA2016-37 amendments by\nA2016-37\n29 Mar 2018\n29 Mar 2018–\nA2018-8 amendments by\nA2018-8\n15 June 2018–\n22 Oct 2018\nA2018-23 amendments by\nA2018-23\n23 Oct 2018\n23 Oct 2018–\n20 Dec 2018\nA2018-33 amendments by\nA2018-33\n21 Dec 2018\n21 Dec 2018–\n14 Aug 2019\nA2018-33 amendments by\nA2018-32\n15 Aug 2019\n15 Aug 2019–\n30 Jan 2020\nA2019-23 amendments by\nA2019-23\n31 Jan 2020\n31 Jan 2020–\nA2019-34 amendments by\nA2019-34\n23 June 2021–\n9 Dec 2022\nA2021-12 amendments by\nA2021-12\n10 Dec 2022\n10 Dec 2022–\n17 Sept 2024\nA2022-24 amendments by\nA2022-24\n18 Sept 2024\n18 Sept 2024–\n17 Apr 2025\nA2024-42 amendments by\nA2024-42\n\nEarlier republications 5\nfor\n18 Apr 2025\n18 Apr 2025–\nA2025-8 amendments by\nA2025-8\n2 June 2025–\n2 Nov 2025\nA2025-16 amendments by\nA2025-16\n3 Nov 2025\n3 Nov 2025–\n25 Nov 2025\nA2025-16 amendments by\nA2024-24","sortOrder":213}],"analysis":{"issue_detection":{"absurdities":[{"type":"retroactive_impossibility","section":"Sections 30(1)(c)(i), 30(2) and 32(1)(c)(ii)","severity":"high","reasoning":"Section 30 requires cancellation when a person is given an authority and a relevant circumstance applies, including that it was issued by an unauthorised person. Section 32 requires written notification within 24 hours after that circumstance happens. If the authority is given more than 24 hours after issue, the deadline has already expired before cancellation triggers the reporting duty.","confidence":0.98,"description":"The written-notification deadline can expire before the person receives and cancels the invalid supply authority.","source_quotes":["the person is given a supply authority for the supply of the substance;","the supply authority was issued by someone who was not authorised to issue it;","not later than 24 hours after the relevant circumstance under section 30 happens, the person fails to—"]}],"contradictions":[]},"flash_summary":{"complexity_score":9,"scope_assessment":{"changed":true,"description":"Yes. The Act has expanded beyond a narrow consolidation of medicines and poisons law into a broader regulatory instrument. Notable scope enlargements in later amendments include: (1) explicit coverage of regulated therapeutic goods and formal incorporation of Commonwealth therapeutic goods laws into ACT law (ch 10, ss156–170), (2) creation of a Monitored Medicines Database to centralise supply/prescription data and allow cross‑jurisdictional data sharing (ch 6A, ss97A–97H; ins. 2018), (3) carve‑outs and policy changes such as the limited cannabis possession/cultivation exemption (s9A; 2019 amendment), and (4) additional topic areas (for example, expanded regulation of vending machines, paints and vaping goods in later amendments). These additions shift the Act from primarily criminal‑sanctioned controls on poisons to an integrated regulatory, surveillance and administrative enforcement regime affecting licensing, data collection, cross‑border enforcement and professional discipline (see ss20, 97D, 157). The effect is a significantly broader regulatory reach and administrative role for the Chief Health Officer than in a plain‑vanilla medicines/poisons statute."},"complexity_factors":["Lengthy primary Act spanning 13 chapters plus Schedule and long dictionary (many parts and subsections).","Extensive defined terms in the dictionary with frequent internal signpost definitions (eg. medicine types, poison schedules, licence definitions).","Heavy cross‑referencing to external instruments: the medicines and poisons standard (ss15–17) and full incorporation/modification of Commonwealth Therapeutic Goods Act (ch 10, ss156–170).","Multiple and differing fault elements across hundreds of offences (strict liability, recklessness, knowledge) producing conditional liability rules (eg. ss27–29, s97H).","Large enforcement framework with detailed procedural rules for entry, warrants, electronic searches, seizure, return/forfeiture and compensation (ch 7, ss102–127, 109–117).","Layered administrative scheme: licences, conditions, amendments, immediate suspensions, disciplinary actions and reviewable decisions (ch 6, ch 8, ch 9, sch 1).","Monitored medicines database regime with data‑sharing, access authorities, cross‑jurisdictional arrangements and offences (ch 6A, ss97D–97H).","Regulation‑making power able to fill technical detail, create new offences and exemptions (ch 12, ss184–190) — creates contingent complexity depending on subordinate instruments.","Nested exceptions and transitional/amendment history across many amending Acts (visible in endnotes) — legal status and scope change over time (eg. cannabis exemption s9A, additions re Voluntary Assisted Dying and vaping)."],"plain_english_summary":"**What this law does (mechanically)**\n\n- Regulates medicines, poisons, certain illegal/prohibited substances and therapeutic goods within the Australian Capital Territory (ACT). It sets out who may manufacture, obtain, possess, supply, prescribe, administer, store, label and discard those things (see s10–s14, s19–s24).  \n- Creates a detailed suite of criminal and regulatory offences for unauthorised or non‑compliant conduct (examples: supplying without authority (s26), manufacturing without authority (s33), supplying therapeutic goods without authority (s74), false statements to obtain substances (s64)). Many offences carry fines and/or imprisonment; some are strict‑liability offences while others require recklessness or knowledge (see, e.g., s27, s28, s29).  \n- Establishes a licensing and authorisation system administered by the Chief Health Officer. Licences specify who may do what, for how long, and on what conditions; the Act sets suitability tests, application and amendment processes, and disciplinary powers (ch 6, ss78–96; ch 8, ss138–146).  \n- Provides enforcement powers to medicines and poisons inspectors, including entry, examination, seizure, destruction, and use of search warrants and electronic evidence (ch 7, ss99–127, 109–117). Procedural safeguards and remedies (receipts, return/forfeiture rules, compensation and court review) are included (ss119–127, 130).  \n- Requires record‑keeping, registers and reporting for many dealings and imposes detailed documentary and retention obligations on pharmacies, hospitals and licence‑holders (Part 4.2, ss46–58).  \n- Creates a Monitored Medicines Database to record supplies and related information about specified medicines (ch 6A, ss97A–97H). Relevant health practitioners have access for clinical and treatment purposes; other parties can apply for access authority subject to conditions. Misuse of the database is an offence (s97H).  \n- Incorporates Commonwealth therapeutic goods laws (the Therapeutic Goods Act 1989 (Cwlth)) into ACT law for ACT purposes and aligns administrative and criminal practice accordingly (ch 10, ss156–170).  \n- Gives the Chief Health Officer powers to issue guidance, directions and approvals (eg. approvals for non‑standard packaging) and allows regulations to fill in technical detail, create further offences and exempt classes of people or dealings (ss191–197; ch 12).\n\n**Who it affects**\n\n- Health practitioners (doctors, nurses, pharmacists, dentists) and veterinary practitioners — prescribing, administering, supply and record duties (eg. ss7, 19, 20, 40–43).  \n- Pharmacies and community pharmacists (licences, registers, inventory requirements; ss48–58, s58).  \n- Manufacturers, wholesalers and importers of medicines, poisons and therapeutic goods — licensing, storage, packaging and labelling requirements, and obligations when supplying by wholesale (ss20(4), 22(2), ch6).  \n- Researchers and recognised research institutions (authorisation and ethics committee requirements for some administration of scheduled substances; s20(3)).  \n- Consumers and patients (safety, information, and limits on what may lawfully be supplied or advertised; ss6, 66).  \n- Interstate suppliers and Commonwealth authorities — the Act expressly addresses interstate wholesalers and applies Commonwealth therapeutic goods laws as Territory law (s139, ch10).  \n\n**Why it matters (stated purpose and tested implications)**\n\n- The Act's declared purpose is to promote and protect public health by reducing poisonings, medicinal mistakes, diversion and harm from therapeutic goods, and to ensure consumers have adequate information (s6). That is the statutory justification for the extensive controls and enforcement powers.  \n\n- Implementation costs and compliance burden: the Act imposes many documentary, record‑keeping and reporting duties (eg. registers ss48–57; reporting loss/theft s39; supply reporting s31) and licensing requirements (ch 6). These translate into ongoing administrative costs for pharmacies, clinics, wholesalers and manufacturers (time, IT systems, compliance officers). The Act enables regulations to specify electronic storage formats and retention (s187), which can increase fixed IT/compliance costs.  \n\n- Surveillance and information centralisation: the Monitored Medicines Database (ss97A–97H) centralises prescribing and supply information for monitored medicines. The Chief Health Officer may collect, share and correct data and permit cross‑jurisdictional arrangements (ss97D–97E). The Legislature authorises penalties for unauthorized access or use of database information (s97H). The Act therefore creates both clinical decision‑support potential and privacy/security implementation obligations (secrecy rules s195).  \n\n- Administrative discretion and decision‑costs: the Chief Health Officer has broad powers to issue, amend, suspend or cancel licences and to take disciplinary action (ss85, 90–93, 141–146). That concentrates decision‑making in a single administrative office; review rights (ACAT) and reviewable‑decision notice requirements exist (ch 9, sch 1) but day‑to‑day discretion is substantial. This raises implementation risk (variation in decision‑making), and potential administrative delay or transaction costs for applicants.  \n\n- Market effects on private enterprise: licensing, supervision requirements and record systems raise the fixed and variable costs of operating pharmacies, wholesalers and smaller operators (ch 6, ch 12). Some regulated activities may become uneconomic for small providers, potentially reducing competition or encouraging consolidation. The Act also enables prohibitions on interstate wholesalers if standards are breached (part 8.1), affecting supply chains (s141(g)).  \n\n- Effects on speech and commercial communications: the Act criminalises certain forms of advertising of controlled medicines and prohibited substances (s66). That restricts promotional communications to the extent specified and gives exemptions for professional publications and regulated advertisers.  \n\n- Criminal enforcement and risk allocation: many offences carry substantial penalties including imprisonment (eg. s26, s33, s74). The Act uses a mix of fault‑elements (strict liability, recklessness, knowledge) across provisions. Corporations and executive officers can be criminally liable where corporate offence provisions apply (s171–172), shifting responsibility up the management chain and creating incentives for internal compliance systems.  \n\n- Cross‑jurisdictional integration: by applying Commonwealth therapeutic goods laws as Territory law (s157 et seq.), the Act aligns ACT conduct with national regulatory and enforcement frameworks, which reduces regulatory fragmentation but also imports Commonwealth administrative processes and criminal law consequences into ACT practice.  \n\n**Trade‑offs, concentrated benefits and opportunity costs (source‑based observations)**\n\n- Trade‑off: stronger public‑health controls and monitoring (database, enforcement) for lower risk of diversion and harm, at the expense of higher compliance costs and administrative burdens for regulated businesses (see ss6, ch6A, Part 4.2).  \n- Concentrated benefits: professional and public health agencies (and patients who rely on safer prescribing) gain from surveillance and disciplinary powers; those benefits are concentrated among regulators and compliant providers.  \n- Diffuse costs: many small practitioners, pharmacies and businesses will shoulder the dispersed administrative costs of compliance (record systems, inventory checks, reporting). The Act itself enables exemptions or regulatory relief in certain cases (s190), which is a mechanism to manage those costs.\n\n**What changes behaviour and who decides**\n\n- Who decides: the Chief Health Officer is the central decision‑maker for licences, approvals, disciplinary action, database arrangements and many administrative functions (eg. ss83, 85, 90–93, 97E, 141). Courts and magistrates have roles in warrants, return/forfeiture, and criminal prosecutions (ch 7, ch 11). ACAT can review many administrative decisions (ch 9, sch 1).  \n- Behaviour changes: providers must obtain and keep authorisations to deal with regulated substances and therapeutic goods, keep prescribed records, follow packaging/label rules, report theft/loss, and comply with storage/security rules. Health practitioners and pharmacists will use the monitored medicines database when authorised; unauthorised access is penalised (ss46–58, 97F–97H). \n\n**Implementation risks**\n\n- Data security/privacy risks for the monitored medicines database (s97D–97H; secrecy and permitted disclosures in s195).  \n- Administrative bottlenecks if licensing or disciplinary processes are slow or opaque (ch 6, ch 8).  \n- Compliance ambiguity where the Act cross‑references the medicines and poisons standard (s15–17) and Commonwealth instruments (ch 10), requiring regulated parties to watch changes in multiple legal instruments.\n\n**Where to look in the Act for key mechanisms**\n\n- Objects and scope: s6, s10–s14.  \n- Core supply and dealing offences: s26 (supply), s33 (manufacture), s74 (therapeutic goods).  \n- Licensing, suitability and conditions: ch 6 (ss78–96).  \n- Monitored Medicines Database: ch 6A (ss97A–97H).  \n- Inspection, entry and seizure powers: ch 7 (ss99–127, 109–117).  \n- Incorporation of Commonwealth therapeutic goods laws: ch 10 (ss156–170).  \n- Regulatory power and exemptions: ch 12 (ss184–190).  \n- Administrative review and reviewable decisions: ch 9 and Schedule 1.\n\n(References in parentheses are to the Act’s sections cited above.)"},"kimi_summary":{"_metrics":{"completionTokens":656},"content_quality":"ok","complexity_score":8,"scope_assessment":{"changed":true,"description":"The Act has expanded significantly beyond its original 2008 scope. Major additions include: Chapter 6A (Monitored medicines database) added in 2018 for real-time prescription tracking; incorporation of vaping goods through amendments to the medicines and poisons standard; expanded paint safety provisions (white lead, pesticides); integration with voluntary assisted dying legislation; and ongoing updates to align with national health practitioner regulation. The enforcement framework has also grown substantially with enhanced inspector powers and digital evidence provisions."},"complexity_factors":["197 sections across 13 chapters plus schedules and dictionary","Extensive cross-referencing with Commonwealth Therapeutic Goods Act 1989 and medicines/poisons standard","Multiple overlapping authorisation pathways (licences, approvals, prescriptions, regulations)","Nested definitions: 'regulated substance' includes medicines, poisons, prohibited substances and schedule 10 substances; each category has sub-definitions","Strict liability offences mixed with fault-based offences requiring careful mental element analysis","Chapter 10 applies Commonwealth laws as territory law with complex modification provisions","Monitored medicines database chapter with separate access controls and offences","Detailed procedural requirements for registers, samples, inspections and warrants","Signpost definitions throughout requiring navigation to multiple locations","Extensive regulation-making powers leaving many details to subordinate legislation"],"plain_english_summary":"This Act is the Australian Capital Territory’s primary law regulating medicines, poisons, prohibited substances and therapeutic goods to protect public health and safety. It controls who may prescribe, supply, manufacture, possess and monitor these products (including a database for controlled medicines), requires licences and records, and gives inspectors and the chief health officer enforcement and disciplinary powers. It affects health practitioners, pharmacies, manufacturers, wholesalers, vets and others handling regulated substances."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/medicines-poisons-and-therapeutic-goods-act-2008","history":"/api/acts/medicines-poisons-and-therapeutic-goods-act-2008/history","analysis":"/api/acts/medicines-poisons-and-therapeutic-goods-act-2008/analysis","conflicts":"/api/acts/medicines-poisons-and-therapeutic-goods-act-2008/conflicts","importantCases":"/api/acts/medicines-poisons-and-therapeutic-goods-act-2008/important-cases","documents":"/api/acts/medicines-poisons-and-therapeutic-goods-act-2008/documents"}}