Medicines, Poisons and Therapeutic Goods Act 2012

1 Short title This Act may be cited as the Medicines, Poisons and Therapeutic Goods Act 2012.

2 Commencement This Act commences on the day fixed by the Administrator by Gazette notice.

3 Objects (1) The main object of this Act is to promote and protect public health and safety by minimising: (a) accidental and deliberate poisoning by Scheduled substances; and (b) misadventures by poisoning by Scheduled substances; and (c) the manufacture of substances that are subject to abuse (substances of abuse); and (d) the diversion for abuse of substances of abuse; and (e) harm from therapeutic goods. (2) Other objects of this Act are to ensure: (a) consumers of Schedule 4 and 8 substances have adequate information and the understanding necessary to allow them to administer the substances safely and effectively; and

Medicines, Poisons and Therapeutic Goods Act 2012 2 (b) consumers of Schedule 2 and 3 substances have adequate information and the understanding to allow them to: (i) select the most appropriate substances for their condition; and (ii) administer the substances safely and effectively, taking into account the condition of their health.

4 Overview (1) The objects of this Act are primarily achieved by prohibiting and regulating people dealing with Scheduled substances. (2) In general, under Part 2.1, only the holder of an authority issued under Chapter 3 may manufacture and, in some circumstances sell, (3) In addition, under Part 2.2, only those authority holders, or health practitioners, veterinarians and others authorised under Part 2.3, may possess, supply or use Scheduled substances. (4) Those general rules are subject to, or complemented by, special rules under Parts 2.4 to 2.8 about the following: (a) the issue of prescriptions for the supply of Scheduled substances by health practitioners and veterinarians; (b) the storage, packaging, labelling, advertisement, supply by vending machines, transport and destruction of Scheduled substances; and (c) the manufacture, supply and use of paints containing Scheduled substances; and (d) other circumstances in which dealing with Scheduled substances may be prohibited. (5) Apart from prohibiting and regulating people dealing with Scheduled substances, Chapter 6 contributes to achieving the objects of this Act by adopting in the Territory a uniform Australian approach to the regulation of therapeutic goods. (6) For the effective administration and enforcement of this Act, provision is made about the following: (a) codes of practice and exemptions; (b) the Scheduled Substances Clinical Advisory Committee;

Medicines, Poisons and Therapeutic Goods Act 2012 3 (c) authorised officers and their functions and powers.

5 Definitions In this Act: Aboriginal and Torres Strait Islander health practitioner, see section 28(1). accepted representations, for Part 3.6, see section 167(4). acting in an official capacity, in relation to an authorised officer, means the officer is exercising powers or performing functions under, or otherwise related to the administration of, this Act. addiction, to a Scheduled substance, means a state of physiological or psychological dependence on, or increased tolerance to, the habitual and excessive use of the substance, and includes pain and other symptomatic indications arising specifically from withdrawal of the substance. administer, see section 22(2). administration order, see section 92(1)(a). affected person, see section 220(2). applied provisions, for Chapter 6, see section 228. appointed members, see section 264(1)(a). approved form means a form approved under section 258. approved SSTP, for Chapter 2, Part 2.3, Division 1, at, for Chapter 4, see section 178. authorised officer, see section 274(1). authorised health practitioner, see section 23(2). authorised prescriber, for a Scheduled substance, means a health practitioner or veterinarian who is authorised under Part 2.4, Division 1, to issue a prescription for the supply of the substance.

Medicines, Poisons and Therapeutic Goods Act 2012 4 authorised purpose means: (a) for the use of a Schedule 4 or unrestricted Schedule 8 substance: (i) analysing or testing specimens for the diagnosis of a disease of humans, animals or plants; or (ia) treatment and prevention of a disease of humans, animals or plants; or (ii) providing a higher education course; or (iii) forensic science; or (iv) preservation of animal or plant specimens; or (v) domestic animal control; or (vi) sedation of wild animals; or (vii) mineral testing; or (viii) another purpose prescribed by regulation; or (c) for the use of a restricted Schedule 8 substance: (i) therapeutic use; or (ii) treating an addiction to a substance; or (iii) analysing or testing specimens for the diagnosis of a disease of humans or animals; or (iiia) treatment and prevention of a disease of humans or (iv) providing a higher education course; or (v) forensic science. authority, see section 117. certificate of registration means: (a) a manufacturer certificate of registration; or (b) a wholesaler certificate of registration; or (c) a Schedule 4 supplier certificate of registration.

Medicines, Poisons and Therapeutic Goods Act 2012 5 CHO means the Chief Health Officer. code of practice means a code of practice in force under section 244. Committee means the Scheduled Substances Clinical Advisory Committee established by section 260. Commonwealth administrative laws, for Chapter 6, see section 228. Commonwealth Minister, for Chapter 6, see section 228. Commonwealth official, for Chapter 6, see section 228. Commonwealth Secretary, for Chapter 6, see section 228. compliance notice, see section 201(1). condition, for Part 3.5, see section 156. connected, for Chapter 4, see section 179. corresponding law: (a) for section 207 – means a law of a State or another Territory that: (i) corresponds, or substantially corresponds, to this Act; and (ii) is declared by regulation to be a corresponding law; or (b) for Chapter 7, Part 7.1AA – see section 243A. data source entity, see section 243A. deal with, for a Scheduled substance, see section 17. declared place means a health centre or clinic declared under section 252 to be a place to which Part 2.6 applies. declared provision, for Part 4.7, Division 1, see section 212. dental hygienist, see section 26(3). dental therapist, see section 26(2). dentist, see section 26(1). doctor, see section 24(1).

Medicines, Poisons and Therapeutic Goods Act 2012 6 endorsed midwife, see section 25(6). enter, for Chapter 4, see section 178. executive officer, of a body corporate, means a director or other person who is concerned with, or takes part in, the management of the body corporate. forfeited thing, for Part 4.4, see section 198(1). health practitioner, see section 23(1). health profession, see section 5 of the Health Practitioner hospital means: (a) a hospital as defined in section 5 of the Medical Services Act 1982; or (b) a private hospital as defined in section 4 of the Private Hospitals Act 1981. information notice, for a decision, means a written notice stating the following: (a) the decision and the reasons for it; (b) that a reconsideration of the decision may be sought; (c) the period allowed for requesting the reconsideration; (d) how to request the reconsideration. interstate prescriber, for a Schedule 4 or 8 substance, means a health practitioner in a State or another Territory who is authorised under the law of that State or Territory to issue a prescription for the supply of the substance. licence means: (a) a retailer licence; or (b) a pest management technician licence. licensed place means a place for which a retailer licence is in force.

Medicines, Poisons and Therapeutic Goods Act 2012 7 manager, for: (a) a hospital declared under section 6(2) of the Medical Services Act 1982 – means the person appointed under section 7(2)(a) of that Act to be the person in charge of the hospital; or (b) a private hospital licensed under the Private Hospitals Act 1981 – see section 4 of that Act. manufacture, see section 18. manufacturer certificate of registration, see section 121. manufacturer's pack, for Part 2.7, Division 2, see section 105. medical kit authorisation, see section 130. medical or scientific research includes for analysis, clinical trials, instruction and study. medicines and poisons standard, see section 14(1). methylated spirit means: (a) a spirit that has been methylated or denatured; or (b) methyl alcohol or wood spirit; or (c) a spirit to which a methylated substance has been added; or (d) a drinkable liquid with which a methylated spirit is mixed. midwife, see section 25(5). minimum repeat interval, for a repeat prescription for the supply of a Scheduled substance, means the period stated in the prescription that limits the frequency of the repeat supplies of the Note Under the Australian Government's Pharmaceutical Benefits Scheme, an authorised prescriber is required to state the minimum repeat interval for some modifications, for Chapter 6, see section 228. monitored medicine, see section 243A. monitored medicines database, see section 243C(1). nominated person, see section 131(c).

Medicines, Poisons and Therapeutic Goods Act 2012 8 NT doctor, see section 24(2). NT health practitioner, see section 23(3). NT nurse practitioner, see section 25(3). NT specialist health practitioner, see section 23(4). nurse, see section 25(1). nurse practitioner, see section 25(2). occupier, of a place: (a) generally, means: (i) a person in occupation of the place; or (ii) the person in control of the place; or (iii) if the place has different parts occupied or controlled by different persons – each person in occupation or control of the part concerned; or (b) for Chapter 4 – see section 178. optometrist, see section 27(1). oral health therapist, see section 26(4). original decision, see section 220(1). paramedic, see section 28A(1). patient, of a hospital, includes a person attending the hospital for treatment as an outpatient by a health practitioner. pesticide, see section 9. pest authorisation, for Chapter 2, Part 2.7, Division 4A, see section 112A. pest management technician licence, see section 126. pharmacist, see section 27(2). pharmacy, see clause 1 of Schedule 7 to the Health Practitioners Act 2004. podiatrist, see section 27(3).

Medicines, Poisons and Therapeutic Goods Act 2012 9 place includes: (a) vacant land; and (b) premises; and (c) an aircraft, vehicle or vessel. possess, see section 20. premises includes: (a) a building or structure; and (b) a part of a building or structure; and (c) land on which a building or structure is situated. prescribed health practitioner, for Chapter 2, Part 2.3, Division 1, prescribed healthcare worker, for Chapter 2, Part 2.3, Division 1, prescription, see section 19. prohibited circumstance, see: (a) for the supply or administration of an unrestricted Schedule 8 substance – section 48(2); or (b) for issuing a prescription for the supply of an unrestricted

Schedule 8 substance – section 84(2). prohibited substance, see section 12. prohibited substance authorisation, see section 128. proposed action, for Part 3.6, see section 167(2)(a). reconsidered decision, see section 223(1)(b). recordable prescription, see section 243B(1) and (2). recordable supply, see section 243B(3) and (4). registered place means a place for which a certificate of registration is in force. relevant prescriber, see section 243A.

Medicines, Poisons and Therapeutic Goods Act 2012 10 repeat prescription means a prescription authorising the supply of a Scheduled substance on more than one occasion. representative, for Part 4.7, Division 1, see section 212. research authorisation, see section 129. residential facility means a residential facility for which an approval is in force under the Aged Care Act 1997 (Cth) for an approved provider to provide residential care to persons in the facility. restricted Schedule 4 substance, see section 8(2). restricted Schedule 8 substance, see section 10(2). retailer licence, see section 123. review notice, see section 223(1)(b). Schedule 3 authorisation, see section 123A. Schedule 4 authorisation, see section 124. Schedule 4 substance declaration means a declaration in force under section 246 for a restricted Schedule 4 substance. Schedule 4 supplier certificate of registration, see section 122A. Schedule 7 authorisation, see section 125(1). Schedule 8 authorisation, see section 127. Schedule 8 exemption means an exemption in force under section 245(1). Scheduled substance, see section 7. Scheduled substance treatment protocol, see section 70B(1). seized thing, for Part 4.4, see section 188. sell, see section 21(3). SSTP means a Scheduled substance treatment protocol. suitable person, for Chapter 3, means: (a) for the holder of an authority – an individual or body corporate that is a suitable person to hold the authority under section 118 or 119; or

Medicines, Poisons and Therapeutic Goods Act 2012 11 (b) for a nominated person for a certificate of registration – an individual who is a suitable person for the authority under section 120. supply, see section 21(1) and (2). supply order, see section 92(1)(b). therapeutic goods, see section 3(1) of the Therapeutic Goods Act. Therapeutic Goods Act means the Therapeutic Goods Act 1989 (Cth). Note Under sections 15(2), 51 and 52 of the Interpretation Act 1978, a reference to a Commonwealth Act includes a reference to: (a) the Act as amended and in force from time to time; and (b) if another Act is enacted in substitution for the Act – the other Act as amended and in force from time to time; and (c) statutory instruments in force under the Act, including, for example: (i) regulations; and (ii) orders; and (iii) manufacturing principles; and (iv) standards, including a medical device standard. therapeutic use, see section 3(1) of the Therapeutic Goods Act. unrestricted Schedule 4 substance, see section 8(1). unrestricted Schedule 8 substance, see section 10(1). unscheduled substance, for Part 2.7, Division 2, see section 105. use, for a Scheduled substance, see section 22(1). variation, for Part 3.5, see section 156. vending machine, for Part 2.7, Division 2, see section 105. veterinarian means a registered veterinarian under the Veterinarians Act 1994. wholesaler certificate of registration, see section 122. Note for section 5 The Interpretation Act 1978 contains definitions and other provisions that may be relevant to this Act.

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7 Meaning of Scheduled substance and related terms (1) A Scheduled substance is a substance to which a Schedule to the medicines and poisons standard applies. See section 16 for when the medicines and poisons standard applies to a (2) A reference to a Scheduled substance by number is a reference to a substance to which the Schedule of that number of the medicines and poisons standard applies. Example for subsection (2) A reference to a Schedule 4 substance is a reference to a substance to which

Schedule 4 of the medicines and poisons standard applies. Note for section 7 Under the medicines and poisons standard, substances are classified according to the Schedules in which they are included. The following is a general description of the substances: (a) Schedule 2 substances may require advice from a pharmacist or retailer licensee to be used safely but are available without a prescription; (b) Schedule 3 substances require advice from a pharmacist to be used safely but are available without a prescription; (c) Schedule 4 substances are available from a pharmacy only on prescription and are commonly known as "prescription only medicines", including prescription animal remedies; (d) Schedule 5 substances have a low potential for causing harm; (e) Schedule 6 substances have a moderate potential for causing harm; (f) Schedule 7 substances have a high potential for causing harm and are available only to the holder of an authority for non-human use; (g) Schedule 8 substances are available only on prescription with restrictions to reduce abuse, misuse or dependence; (h) Schedule 9 substances are generally illegal substances that are subject to abuse or misuse; (i) Schedule 10 substances are substances, other than Schedule 9 substances, the supply and use of which are prohibited because of the degree of danger to health they represent.

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8 Meaning of unrestricted Schedule 4 substance and restricted Schedule 4 substance (1) An unrestricted Schedule 4 substance is a substance other than a restricted Schedule 4 substance. (2) A restricted Schedule 4 substance is a substance declared under section 246(1)(a) to be a restricted Schedule 4 substance.

9 Meaning of pesticide A pesticide is a substance that is: (a) a Schedule 5, 6 or 7 substance; and (b) a pesticide as defined in the medicines and poisons standard.

10 Meaning of unrestricted Schedule 8 substance and restricted Schedule 8 substance (1) An unrestricted Schedule 8 substance is a Schedule 8 substance other than a restricted Schedule 8 substance. (2) A restricted Schedule 8 substance is a Schedule 8 substance declared under section 246(1)(b) to be a restricted Schedule 8

12 Meaning of prohibited substance A prohibited substance is any of the following substances: (a) a Schedule 9 substance; (b) a Schedule 10 substance.

14 Meaning of medicines and poisons standard (1) The medicines and poisons standard is the poisons standard as in force from time to time as modified under this section. (2) A regulation may declare a substance is taken to be included in, or excluded from, a provision of the medicines and poisons standard. (3) The declaration may impose restrictions in relation to dealings with

Medicines, Poisons and Therapeutic Goods Act 2012 14 (4) For subsection (1), but subject to a modification under this section: (a) an amendment of a current poisons standard takes effect on the date of effect of the instrument of amendment under the Legislative Instruments Act 2003 (Cth); and (b) a new poisons standard takes effect on the date of effect of the standard under the Legislative Instruments Act 2003 (Cth). current poisons standard means the current Poisons Standard as defined in section 52A of the Therapeutic Goods Act. new poisons standard means a document prepared under section 52D(2)(b) of the Therapeutic Goods Act. poisons standard means the document prepared under section 52D(2) of the Therapeutic Goods Act.

15 Interpretation provisions in medicines and poisons standard – application to Act (1) A term defined in the medicines and poisons standard has the same meaning in this Act. (2) A provision of the medicines and poisons standard relating to the interpretation of the standard applies in the interpretation of this Act. Examples for subsection (2) 1 Subject to stated exceptions, a reference in the medicines and poisons standard to a substance in a Schedule or Appendix to the standard includes: (a) a substance prepared from natural sources or artificially; and (b) every salt, active principle or derivative of the substance; and (c) a preparation or admixture containing any proportion of the 2 Accordingly, subject to the exceptions, a reference to the substance in this Act includes a reference to those things. 3 In addition, unless there is a contrary intention, the standard does not apply to the following: (a) a substance in stated preparations or products; (b) stated substances; (c) some low concentrations of stated substances; (d) some impurities in pesticides. Note for section 15 Under section 30, this Act prevails if there is an inconsistency between this Act and the medicines and poisons standard.

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16 When medicines and poisons standard applies to substances For this Act, a Schedule or Appendix to the medicines and poisons standard applies to a substance in a circumstance if: (a) the substance is included in the Schedule or Appendix; and (b) either: (i) the standard does not, in the circumstance, exclude the substance from the operation of the Schedule or Appendix; or (ii) a restriction in the standard applies in relation to the substance in the circumstance. Example for paragraph (b)(ii) If a Schedule 2 substance is listed as restricted "for human therapeutic use" and the substance is included only in that schedule, the standard applies to the substance only for human therapeutic use.

17 Meaning of deal with To deal with a Scheduled substance is to do any of the following: (a) manufacture the substance; (b) issue a prescription for the supply of the substance; (c) issue an administration order or supply order for administering or supplying the substance; (d) possess the substance; (e) supply the substance to another person; (f) administer the substance to another person or otherwise use the substance; (g) pack, label or advertise the substance; (h) store or transport the substance, including import it into the Territory; (i) destroy the substance; (j) something else prescribed by regulation.

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18 Meaning of manufacture Manufacture includes the following: (a) produce; (b) make or prepare; (c) mix, extract or refine; (d) pack or repack for: (i) sale by wholesale; or (ii) use in connection with a business, industry, profession or trade.

19 Meaning of prescription A prescription, for a Scheduled substance, is a written instruction authorising the supply of the substance for: (a) administering to a particular person; or (b) administering to animals. Notes for section 19 1 A prescription may be issued electronically in accordance with the Electronic Transactions (Northern Territory) Act 2000. 2 Part 2.4, Division 1 contains provisions about who is authorised to issue prescriptions for Scheduled substances. Part 2.4, Division 2 contains other requirements about the content, issue and duration of prescriptions for

20 Meaning of possess Possess, in relation to a Scheduled substance, includes: (a) receive or obtain possession of the substance; and (b) have control over the disposition of the substance (whether with or without custody of it); and (c) have joint possession of the substance.

21 Meaning of supply and sell (1) Supply, of a Scheduled substance, includes: (a) sell the substance; and

Medicines, Poisons and Therapeutic Goods Act 2012 17 (b) provide the substance on prescription. (2) However, supply of a Scheduled substance does not include issue a prescription for the supply of the substance. (3) Sell, in relation to a Scheduled substance, includes: (a) offer or expose the substance for sale; and (b) dispose of the substance by any method for value (or offer or expose the substance for disposal by any method for value).

22 Meaning of use and administer (1) Use, in relation to a Scheduled substance, includes administer the (2) Administer, a Scheduled substance, is to apply or introduce the substance to the body of a person or animal.

Subdivision 4 Health practitioners and others authorised to deal with Scheduled substances

23 Meaning of health practitioner and related terms (1) A health practitioner is a person registered under the Health Practitioner Regulation National Law to practise a health profession (other than as a student). (2) An authorised health practitioner is: (a) an NT doctor or NT nurse practitioner; or (b) another NT health practitioner prescribed by regulation. (3) An NT health practitioner is a health practitioner who practises in the Territory. (4) An NT specialist health practitioner is a person who: (a) is registered under the Health Practitioner Regulation National Law in a recognised specialty; and (b) practises in the Territory.

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24 Meaning of doctor and NT doctor (1) A doctor is a medical practitioner. A medical practitioner is defined in section 17 of the Interpretation Act 1978 to be a person registered under the Health Practitioner Regulation National Law to practise in the medical profession (other than as a student). (2) An NT doctor is a doctor who practises in the Territory.

25 Meaning of nurse, midwife and related terms (1) A nurse is a health practitioner registered under the Health Practitioner Regulation National Law to practise in the nursing profession (other than as a student). (2) A nurse practitioner is a nurse whose registration under the Health Practitioner Regulation National Law is endorsed as being qualified to practise as a nurse practitioner. (3) An NT nurse practitioner is a nurse practitioner who practises in the Territory. (5) A midwife is a health practitioner registered under the Health Practitioner Regulation National Law to practise in the midwifery profession (other than as a student). (6) An endorsed midwife is a midwife whose registration under the Health Practitioner Regulation National Law is endorsed as being qualified to possess, issue a prescription for the supply of, supply or administer a Scheduled substance.

26 Meaning of dentist and dental therapist (1) A dentist is a person registered under the Health Practitioner Regulation National Law: (a) to practise in the dental profession as a dentist (other than as a student); and (b) in the dentists division of that profession. (2) A dental therapist is a person registered under the Health (a) to practise in the dental profession as a dental therapist (other than as a student); and (b) in the dental therapists division of that profession.

Medicines, Poisons and Therapeutic Goods Act 2012 19 (3) A dental hygienist is a person registered under the Health (a) to practise in the dental profession as a dental hygienist (other than as a student); and (b) in the dental hygienists division of that profession. (4) An oral health therapist is a person registered under the Health (a) to practise in the dental profession as an oral health therapist (other than as a student); and (b) in the oral health therapists division of that profession.

27 Meaning of optometrist, pharmacist and podiatrist (1) An optometrist is a person registered under the Health Practitioner Regulation National Law to practise in the optometry profession (2) A pharmacist is a person registered under the Health Practitioner Regulation National Law to practise in the pharmacy profession (3) A podiatrist is a person registered under the Health Practitioner Regulation National Law to practise in the podiatry profession

28 Meaning of Aboriginal and Torres Strait Islander health practitioner An Aboriginal and Torres Strait Islander health practitioner is a person registered under the Health Practitioner Regulation National Law to practise in the Aboriginal and Torres Strait Islander health practice profession (other than as a student).

28A Meaning of paramedic A paramedic is a person registered under the Health Practitioner Regulation National Law to practise in the paramedicine profession (other than as a student).

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29 Act binds Crown (1) This Act binds the Crown in right of the Territory and, to the extent the legislative power of the Legislative Assembly permits, the Crown in all its other capacities. (2) However, this Act does not make the Crown liable to be prosecuted for an offence.

30 Inconsistency between Act and medicines and poisons standard This Act prevails if there is an inconsistency between this Act and the medicines and poisons standard.

31 Relationship with Health Practitioner Regulation National Law A health practitioner's authorisation under this Act to deal with a Scheduled substance is subject to the conditions or other restrictions to which the health practitioner is subject under the Health Practitioner Regulation National Law. Note for section 31

Part 2.3, Division 1 and Part 2.4, Division 1 authorise health practitioners in the Territory to possess, supply, administer and issue prescriptions for Scheduled substances they are qualified to do under the Health Practitioner Regulation National Law. In particular, this includes an authorisation for a qualification endorsed on a health practitioner's certificate of registration in addition to the specific authorisations, see sections 73 and 86.

31A Relationship with Hemp Industry Act 2019 (1) This Act does not affect the operation of the Hemp Industry Act 2019 or make unlawful anything done in accordance with that Act. (2) Without limiting subsection (1), this Act does not apply to processed low THC hemp as defined in section 4A(3) of the Misuse of Drugs Act 1990.

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32 Relationship with Misuse of Drugs Act 1990 This Act does not affect the operation of the Misuse of Drugs Act 1990 in relation to Scheduled substances that are dangerous drugs as defined in that Act except to the extent to which this Act provides otherwise (whether expressly or by necessary implication). Notes for section 32 1 Under the Misuse of Drugs Act 1990, it is unlawful to manufacture, possess, supply or administer a dangerous drug. Some prohibited substances and some Schedule 4 and 8 substances are dangerous drugs. However, the manufacture, possession, supply or administration of those substances may be lawful under that Act because a manufacturer certificate of registration, prohibited substance authorisation or Schedule 8 authorisation authorises the activity, see sections 121, 127 and 128. 2 In addition, Part 2.3 authorises the possession, supply and use of Schedule 8 substances by some people in some circumstances.

33 Application of Criminal Code Part IIAA of the Criminal Code applies to an offence against this Act. Notes for section 33 1 Part IIAA of the Criminal Code states the general principles of criminal responsibility, establishes general defences, and deals with burden of proof. It also defines, or elaborates on, certain concepts commonly used in the creation of offences. 2 In particular, under section 43BE of the Criminal Code, a person is not criminally responsible for an offence if the conduct constituting the offence is justified or excused by or under a law. Accordingly, the authorisations for health practitioners and others to deal with Scheduled substances under Part 2.3 provide a defence to an offence against Part 2.1 or 2.2.

Part 2.1 Requirements for registration and licensing of manufacturers, wholesalers and retailers Medicines, Poisons and Therapeutic Goods Act 2012 22 Part 2.1 Requirements for registration and licensing of manufacturers, wholesalers and retailers

34 Manufacturer of certain Scheduled substances to be registered (a) manufactures a Scheduled substance, other than a Schedule 5 or 6 substance, at a place; and (b) is not authorised under a manufacturer certificate of registration to manufacture the substance at the place. (2) Subsection (1) does not apply to: (a) a health practitioner or veterinarian preparing or mixing the substance for the treatment of a person or animal in the course of practising in the health practitioner's health profession or providing veterinary services; or (b) an employee of a health practitioner or veterinarian who prepares or mixes the substance under the direct supervision of a health practitioner or veterinarian for the treatment of a person or animal in the course of practising in the health practitioner's health profession or providing veterinary services. (3) In addition, subsection (1) does not apply to a person if: (a) the substance is a Schedule 4 or 8 substance; and (b) the substance is supplied to the person under a Schedule 4 or 8 authorisation; and (c) the person prepares the substance for self-administration; and (d) the person does not supply it to anyone else.

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35 Wholesaler of certain Scheduled substances to be registered (a) sells by wholesale a Scheduled substance, other than a

Schedule 5 or 6 substance, from a place; and (b) the sale is not authorised under a wholesaler certificate of registration. (2) Subsection (1) does not apply to a sale of the substance by a pharmacist in the course of practising in the pharmacy profession.

36 Retailer of Schedule 2 and 7 substances to be licensed (a) sells by retail a Schedule 2 or 7 substance from a place; and (b) the sale is not authorised under a retailer licence. (2) Subsection (1) does not apply to a pharmacist selling a Schedule 2 substance in the course of practising in the pharmacy profession. Part 2.2 Requirements for authorised possession, supply and use of Scheduled substances

37 Supply of Schedule 3 substance (a) the person intentionally supplies a substance to another (b) the substance is a Schedule 3 substance and the person is reckless in relation to that circumstance; and

Medicines, Poisons and Therapeutic Goods Act 2012 24 (c) the supply of the substance by the person is not authorised under this Act. (2) Strict liability applies to subsection (1)(c).

38 Administration of Schedule 3 substance (a) the person intentionally administers a substance to another (b) the substance is a Schedule 3 substance and the person is reckless in relation to that circumstance; and (c) the administration of the substance by the person is not authorised under this Act. (2) Strict liability applies to subsection (1)(c). subsection (1) if the defendant believed on reasonable grounds that: (a) the person to whom the Schedule 3 substance was administered was in danger of dying or of suffering a serious disability; and (b) the administration of the Schedule 3 substance to that person was required to prevent the person from dying or suffering a serious disability. Note for subsection (3) The defendant has an evidential burden in relation to this defence (see section 43BU of the Criminal Code).

39 Possession A person must not possess a Schedule 4 substance unless the possession is authorised under: (b) a Schedule 4 authorisation; or

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40 Supply A person must not supply a Schedule 4 substance to someone (b) a medical kit authorisation. 41 Use A person must not use a Schedule 4 substance unless the use is authorised under: (a) a Schedule 4 authorisation; or (b) a research authorisation; or (c) a medical kit authorisation.

42 Supply by authorised persons only A person must not supply a Schedule 7 substance to someone (b) a retailer licence.

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43 Supply to authorised persons only (1) A person (the supplier) must not supply a Schedule 7 substance to someone (the recipient) unless: (a) the recipient shows the supplier one of the following authorising the recipient to use the substance: (i) a Schedule 7 authorisation; (ii) a pest management technician licence; (iii) a research authorisation; (iv) a licence endorsed for the substance under Part 5,

Division 2 of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004; (v) an S7 authorisation under the Agricultural and Veterinary Chemicals (Control of Use) Regulations 2005; or (b) the supplier is satisfied, by a statutory declaration made by the recipient, that the recipient: (i) intends to use the substance only in a place outside the Territory; and (ii) is authorised under the law of that place to use the (c) the recipient is exempted by regulation from the requirement to hold: (i) a Schedule 7 authorisation for the use of the substance; or (ii) a pest management technician licence for the use of the (2) If the supplier supplies a Schedule 7 substance to the recipient under subsection (1)(b), the supplier must keep the declaration for 2 years after the date of the supply.

Medicines, Poisons and Therapeutic Goods Act 2012 27 subsection (2) if the defendant establishes a reasonable excuse. 44 Use (1) A person must not use a pesticide in carrying out pest control operations for fee or reward unless: (a) the use is authorised under: (i) a pest management technician licence; or (ii) a licence under Part 5, Division 2 of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004; or (iii) an S7 authorisation under the Agricultural and Veterinary Chemicals (Control of Use) Regulations 2005; or (i) is employed by the holder of a pest management technician licence; and (ii) uses the pesticide under the direct supervision of the licensee. (2) A person must not use a Schedule 7 substance (other than a pesticide) unless the use is authorised under: (a) a Schedule 7 authorisation; or (b) a research authorisation. (3) Subsections (1) and (2) do not apply if the person is exempted by regulation from the requirement to hold an authority mentioned in the subsection for the use of the substance.

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45 Possession A person must not possess an unrestricted Schedule 8 substance unless the possession of the substance is authorised under: (b) a Schedule 8 authorisation; or

46 Supply generally A person must not supply an unrestricted Schedule 8 substance to someone unless the supply is authorised under a certificate of registration.

47 Use generally A person must not use an unrestricted Schedule 8 substance unless the use is authorised under: (a) a Schedule 8 authorisation; or (b) a research authorisation; or (c) a medical kit authorisation.

Medicines, Poisons and Therapeutic Goods Act 2012 29

48 Supplying and administering in prohibited circumstances (1) An authorised health practitioner must not supply or administer an unrestricted Schedule 8 substance to someone in a prohibited circumstance mentioned in subsection (2) unless the supply or administration is authorised under: (a) a Schedule 8 authorisation; or (b) a Schedule 8 exemption. (2) Each of the following is a prohibited circumstance for the supply or administration of an unrestricted Schedule 8 substance: (a) for treating a person's addiction to a substance; (b) for another purpose prescribed by regulation.

49 Possession A person must not possess a restricted Schedule 8 substance unless the possession is authorised under: (b) a Schedule 8 authorisation for an authorised purpose; or (c) a Schedule 8 exemption for an authorised purpose; or (d) a research authorisation; or (e) a medical kit authorisation. Note for section 49 Under section 139(1)(b), a Schedule 8 authorisation for the possession of a restricted Schedule 8 substance may be issued only to an authorised health practitioner for supply or administration for an authorised purpose. In addition, under section 245, the CHO may issue a Schedule 8 exemption to an authorised health practitioner for the possession of a restricted Schedule 8 substance for its supply for an authorised purpose.

Medicines, Poisons and Therapeutic Goods Act 2012 30

50 Supply A person must not supply a restricted Schedule 8 substance to someone unless the supply is authorised under: (b) a Schedule 8 authorisation for an authorised purpose; or (c) a Schedule 8 exemption for an authorised purpose. Maximum penalty: 400 penalty units or imprisonment for 4 years. Note for section 50 Under section 139(1)(b), a Schedule 8 authorisation for the supply of a restricted Schedule 8 substance may be issued only to an authorised health practitioner for supply for an authorised purpose. In addition, under section 245, the CHO may issue a Schedule 8 exemption to an authorised health practitioner for the supply of a restricted Schedule 8 substance for an authorised purpose. 51 Use A person must not use a restricted Schedule 8 substance unless the use is authorised under: (a) a Schedule 8 authorisation for an authorised purpose; or (b) a Schedule 8 exemption for an authorised purpose; or Note for section 51 Under section 139(1)(b), a Schedule 8 authorisation for the administration of a restricted Schedule 8 substance may be issued only to an authorised health practitioner for administration for an authorised purpose. In addition, under section 245, the CHO may issue a Schedule 8 exemption to an authorised health practitioner for the administration of a restricted Schedule 8 substance for an authorised purpose.

Medicines, Poisons and Therapeutic Goods Act 2012 31

52 Possession (1) A person must not possess a prohibited substance unless the possession is authorised under: (b) a prohibited substance authorisation; or (c) a research authorisation. (2) Subsection (1) does not apply to a person possessing the substance if: (a) the substance is subject to an exemption under section 18 of the Therapeutic Goods Act for use of the substance solely for experimental purposes in humans; or (b) the person uses the substance in the treatment of another person or experimental purposes in humans under an approval given under section 19 of the Therapeutic Goods Act. Note for section 52 Under section 140, a prohibited substance authorisation for the possession of a (a) for etorphine – a veterinarian or other prescribed person for use to sedate (b) for other prohibited substances – an authorised health practitioner for administration for the treatment of a person's terminal illness.

53 Supply A person must not supply a prohibited substance to someone

Medicines, Poisons and Therapeutic Goods Act 2012 32 (b) a prohibited substance authorisation. Maximum penalty: 500 penalty units or imprisonment for 5 years. Note for section 53 Under section 140, a prohibited substance authorisation for the supply of a (a) for etorphine – a veterinarian or other prescribed person for use to sedate (b) for other prohibited substances – an authorised health practitioner for administration for the treatment of a person's terminal illness. 54 Use (1) A person must not use a prohibited substance unless the use is authorised under: (a) a prohibited substance authorisation; or (b) a research authorisation. (2) Subsection (1) does not apply to a person using the substance if: (a) the substance is subject to an exemption under section 18 of the Therapeutic Goods Act for use of the substance solely for experimental purposes in humans; or (b) the person uses the substance in the treatment of another person or experimental purposes in humans under an approval given under section 19 of the Therapeutic Goods Act. Note for section 54 Under section 140, a prohibited substance authorisation for the use of a (a) for etorphine – a veterinarian or other prescribed person to sedate animals; or (b) for other prohibited substances – an authorised health practitioner for the treatment of a person's terminal illness.

Medicines, Poisons and Therapeutic Goods Act 2012 33 Part 2.3 Authorisations for possession, supply and use of Schedule 3, 4 and 8 substances Division 1 Authorisations for health practitioners and other health-related occupations Subdivision 1 Authorised health practitioners 55 Schedule 4 substances and unrestricted Schedule 8 (1) An authorised health practitioner may, in the course of practising in the health practitioner's health profession: (2) However, the health practitioner must supply and administer a restricted Schedule 4 substance in accordance with the conditions stated in the declaration of the substance as a restricted

56 Possessing Schedule 4 and 8 substances A pharmacist may, in the course of practising in the pharmacy profession, possess Schedule 4 and 8 substances for supply: (a) under this Subdivision; or (b) in another circumstance prescribed by regulation.

57 Supplying Schedule 4 and 8 substances – general profession, supply a Schedule 4 or 8 substance: (a) to an authorised prescriber for the substance; or (b) to a person on a prescription issued by an authorised prescriber (other than an interstate prescriber) for the

Medicines, Poisons and Therapeutic Goods Act 2012 34 (c) on a written supply order for the substance to: (i) a person who was a patient of a hospital on the person's discharge from the hospital; or (ii) a nurse employed at a residential facility for administration to a resident at the facility; or (iii) the person in charge of a declared place for administration to a person receiving medical treatment at the place; or (d) to another pharmacist for the other pharmacist to supply the substance in the course of practising in the pharmacy profession; or (e) to the master of a ship, who is authorised or required under the Navigation Act 2012 (Cth) to carry the substance on board the ship, on the written request of the master or ship's medical officer; or (f) to the holder of a research authorisation or medical kit authorisation for the substance; or (g) for a Schedule 4 substance – to the holder of a Schedule 4 authorisation; or (h) to a person prescribed by regulation. Note for subsection (1)(d) A pharmacist is not required to have a wholesaler certificate of registration for the wholesale supply of the substances in the course of practising the pharmacy profession, see section 35(2). Note for subsection (1)(e) Orders made by the Australian Maritime Safety Authority under the Navigation Act 1912 (Cth) also authorise some people to deal with the substance. Accordingly, a person who deals with the substance in accordance with the orders is not criminally responsible for an offence against Part 2.1, see section 43BE of the Criminal Code. (2) In addition, a pharmacist employed at a hospital may, in the course of practising in the pharmacy profession, supply a Schedule 4 or 8 substance to one of the following health practitioners on the written requisition of the health practitioner containing the information prescribed by regulation: (a) a doctor, dentist, nurse practitioner or endorsed midwife employed or engaged at the hospital;

Medicines, Poisons and Therapeutic Goods Act 2012 35 (b) the nurse in charge of a ward or department of the hospital.

58 Supplying Schedule 4 and 8 substances – prescription of interstate prescribers person on a prescription issued by an interstate prescriber. (2) A pharmacist may, in the course of practising in the pharmacy profession, supply a Schedule 8 substance or restricted Schedule 4 substance to a person on a prescription issued by an interstate prescriber in accordance with: (a) the conditions prescribed by regulation applying to the supply; or (b) an approval under section 253.

59 Supplying unrestricted Schedule 4 substance in emergency for patient previously supplied on prescription person (the patient), or another person who acts for the patient (the agent) if: (a) the pharmacist is reasonably satisfied supplying the substance is justified because of urgent circumstances; and (b) the pharmacist, or another pharmacist, has previously supplied the substance for administration to or by the patient on the prescription of an authorised prescriber for the (c) for a supply to the agent: (i) the agent gives the pharmacist the name and contact details of the authorised prescriber; and (ii) the agent produces to the pharmacist proof of the agent's identity. than: (a) 7 days supply of the substance administered at the daily dose the pharmacist reasonably believes the authorised prescriber would recommend be administered to the patient; or

Medicines, Poisons and Therapeutic Goods Act 2012 36 (b) the smallest primary pack of the substance that has been packaged and labelled by the substance's manufacturer in compliance with the medicines and poisons standard.

59A Supplying unrestricted Schedule 4 substance – continued dispensing A pharmacist may, in the course of practising in the pharmacy person if: (a) the substance is a pharmaceutical benefit that is covered by an instrument made under section 89A(3) of the National Health Act 1953 (Cth); and (b) the supply is made in accordance with the conditions that are specified in that instrument as if the pharmacist were an approved pharmacist.

60 Supplying unrestricted Schedule 4 substance for patient in residential care person (the agent), for administration to or by another person for whom the agent acts (the patient) if: (a) the pharmacist has previously supplied the substance to the agent or patient for administration to the patient on the prescription of an authorised prescriber for the substance; and (b) the pharmacist is satisfied the patient: (i) is in residential care; and (ii) the substance is administered in accordance with a therapeutic regime decided by a health practitioner for treatment of a chronic medical condition; and (c) for a supply to the agent: (i) the agent gives the pharmacist the name and contact details of the authorised prescriber; and (ii) the agent produces to the pharmacist proof of the agent's identity.

Medicines, Poisons and Therapeutic Goods Act 2012 37 than: (a) 7 days supply of the substance administered at the daily dose the pharmacist reasonably believes an authorised prescriber would recommend be administered to the patient; or (b) the smallest primary pack of the substance that has been packaged and labelled by the substance's manufacturer in compliance with the medicines and poisons standard.

61 Supplying Schedule 4 and 8 substances on oral request of authorised prescriber profession, supply a Schedule 4 or 8 substance to a person (the patient), or another person who acts for the patient (the agent) if the pharmacist: (a) has been orally requested to supply the substance to: (i) the patient for self-administration or administration to the patient by someone else; or (ii) the agent for administration to the patient by the agent or someone else; and (b) is satisfied the person making the request is an authorised prescriber for the substance. than 7 days supply of the substance administered at the daily dose stated by the authorised prescriber.

Medicines, Poisons and Therapeutic Goods Act 2012 38

63 Administering Schedule 4 or 8 substances under administration order – Aboriginal and Torres Strait health practitioners, nurses, midwives and pharmacists (1) Subject to subsection (2), if an authorised prescriber has, by administration order, authorised an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist (the practitioner) to administer a Schedule 4 or 8 substance to another person, the practitioner may, in the course of practising in the practitioner's health profession, administer the substance to the person. See section 92(1)(a)(i) to (iv) in relation to the persons to whom an authorised prescriber for a Schedule 4 or 8 substance may, by administration order, authorise the administration of the substance to. (2) The practitioner must administer the substance in accordance with any instructions given by the authorised prescriber. (3) A practitioner who is authorised to administer a Schedule 4 or 8 substance to a person under this section may, in the course of practising in the practitioner's health profession, possess the substance for that purpose.

64 Administering Schedule 4 or 8 substances supplied on supply order – nurses employed at residential facilities (1) Subject to subsection (2), a nurse employed at a residential facility may, in the course of practising in the nursing profession, administer a Schedule 4 or 8 substance to a resident at the facility if: (a) the substance was supplied by a pharmacist on a supply order issued by an authorised prescriber; and (b) the prescriber authorised the supply of the substance for the purpose of its administration to the resident. Notes for subsection (1) 1 Under section 92(1)(b)(ii), an authorised prescriber for a Schedule 4 or 8 substance may, by supply order, authorise the supply of the substance by a pharmacist to a nurse employed at a residential facility for administration to a resident at the facility. 2 Under section 57(1)(c)(ii), a pharmacist may supply a Schedule 4 or 8 substance on a written supply order for the substance to a nurse employed at a residential facility for administration to a resident at the facility.

Medicines, Poisons and Therapeutic Goods Act 2012 39 (2) The nurse must administer the substance in accordance with any instructions for its administration specified by the authorised prescriber in the supply order. (3) A nurse who is authorised to administer a Schedule 4 or 8 substance to a resident at a residential facility under this section may, in the course of practising in the nursing profession, possess the substance for that purpose.

66 Dentists A dentist may, in the course of practising in the dental profession as a dentist:

68 Optometrists An optometrist may, in the course of practising in the optometry profession: (a) supply or administer an unrestricted Schedule 4 substance to another person; and

69 Podiatrists A podiatrist may, in the course of practising in the podiatry profession:

Subdivision 3A Administering, supplying and possessing Scheduled substances under SSTP

70 Definitions In this Subdivision: approved SSTP means an SSTP for which an approval under section 254 is in effect.

Medicines, Poisons and Therapeutic Goods Act 2012 40 prescribed health practitioner means a health practitioner of a type prescribed by regulation under section 70A(1). prescribed healthcare worker means a person who is a member of a class of persons prescribed by regulation under section 70A(2).

70A Prescribed health practitioners and healthcare workers (1) The regulations may prescribe a type of health practitioner that may be authorised under this Subdivision to administer or supply a Schedule 4 or 8 substance in accordance with an approved SSTP. (2) The regulations may prescribe a class of persons that provide health services, other than a health practitioner, that may be authorised under this Subdivision to administer or supply a Schedule 3, 4 or 8 substance in accordance with an approved SSTP. Note for section 70A For the administration or supply of a Schedule 3 substance by a health practitioner, see sections 71 and 72.

70B Form and content of SSTP (1) A Scheduled substance treatment protocol is a document setting out protocols for the administration or supply of: (a) a Schedule 4 or 8 substance by the prescribed health practitioner, or the class of prescribed health practitioners, specified in the document in the circumstances specified in the document; or (b) a Schedule 3, 4 or 8 substance by the prescribed healthcare worker, or the class of prescribed healthcare workers, specified in the document in the circumstances specified in the document. (2) An SSTP must specify the following matters: (a) the prescribed health practitioner or prescribed healthcare worker, or the class of prescribed health practitioners or prescribed healthcare workers, in relation to which it applies; (b) if the SSTP applies to a prescribed health practitioner or a class of prescribed health practitioner – the Schedule 4 or 8 substance in relation to which it applies;

Medicines, Poisons and Therapeutic Goods Act 2012 41 (c) if the SSTP applies to a prescribed healthcare worker or a class of prescribed healthcare worker – the Schedule 3, 4 or 8 substance in relation to which it applies; (d) the circumstances in which the substance may be administered or supplied to another person in accordance with the SSTP, including with reference to the matters prescribed by regulation; (e) any other matter prescribed by regulation. (3) For subsection (2)(a), a class of prescribed health practitioners or class of prescribed healthcare workers may be identified in an SSTP by reference to one or more of the following criteria: (a) a qualification held, or training that has been undertaken, by members of the class; (b) the employment circumstances of members of the class; (c) a place at which members of the class practise their health profession or provide health services; (d) any other criteria prescribed by regulations. Note for section 70B An SSTP is required to be approved by the CHO under section 254 before a prescribed health practitioner or prescribed healthcare worker to which the SSTP applies may administer or supply the specified Scheduled substance in accordance with it.

70C Administering, supplying and possessing Schedule 4 or 8 substance under SSTP – prescribed health practitioners (1) Subject to subsection (2), a prescribed health practitioner may, in the course of practising in the practitioner's health profession, administer a Schedule 4 or 8 substance to another person if: (a) an approved SSTP for the administration of the substance applies to the practitioner; and (b) the administration of the substance to the other person is in the circumstances specified in the approved SSTP. (2) The prescribed health practitioner must administer the substance in

Medicines, Poisons and Therapeutic Goods Act 2012 42 (3) Subject to subsection (4), a prescribed health practitioner may, in the course of practising in the practitioner's health profession, supply a Schedule 4 or 8 substance to another person if: (a) an approved SSTP for the supply of the substance applies to the practitioner; and (b) the supply of the substance to the other person is in the circumstances specified in the approved SSTP. (4) The prescribed health practitioner must supply the substance in (5) A prescribed health practitioner who is authorised to administer or supply a Schedule 4 or 8 substance to another person under this section may, in the course of practising in the practitioner's health profession, possess the substance for that purpose.

70D Administering, supplying and possessing Schedule 3, 4 or 8 substance under SSTP – prescribed healthcare workers (1) Subject to subsection (2), a prescribed healthcare worker may, in the course of providing health services, administer a Schedule 3, 4 or 8 substance to another person if: (a) an approved SSTP for the administration of the substance applies to the healthcare worker; and (b) the administration of the substance to the other person is in the circumstances specified in the approved SSTP. (2) The prescribed healthcare worker must administer the substance in (3) Subject to subsection (4), a prescribed healthcare worker may, in the course of providing health services, supply a Schedule 3, 4 or 8 substance to another person if: (a) an approved SSTP for the supply of the substance applies to the healthcare worker; and (b) the supply of the substance to the other person is in the circumstances specified in the approved SSTP. (4) The prescribed healthcare worker must supply the substance in

Subdivision 5 Additional qualifications for health practitioners under Health Practitioner Medicines, Poisons and Therapeutic Goods Act 2012 43 (5) A prescribed healthcare worker who is authorised to administer or supply a Schedule 4 or 8 substance to another person under this section may, in the course of providing health services, possess the substance for that purpose. Subdivision 4 Special provisions for health practitioners to supply and administer Schedule 3 substances

71 Supplying Schedule 3 substances (1) Subject to subsection (4), a health practitioner may, in the course of practising in the practitioner's health profession, supply a

Schedule 3 substance to another person (the recipient). (2) A health practitioner who supplies a Schedule 3 substance under subsection (1) must, at the time of the supply, give the recipient adequate instructions (written or oral) for the administration of the (3) The health practitioner must give the instructions to the recipient under subsection (2) even if the Schedule 3 substance that is supplied is to be used by a person other than the recipient. (4) Subsection (1) does not authorise the sale by retail of a Schedule 3 substance by a health practitioner other than a pharmacist.

72 Administering Schedule 3 substances A health practitioner may, in the course of practising in the practitioner's health profession, administer a Schedule 3 substance to another person. Subdivision 5 Additional qualifications for health practitioners under Health Practitioner Regulation National Law

73 Endorsement on health practitioner's registration for additional qualifications (1) This section applies to a health practitioner whose registration under the Health Practitioner Regulation National Law is endorsed as qualified to possess, supply or administer, a Scheduled substance (the endorsed qualification) in addition to an authorisation under this Division. Part 7, Division 3 of the Health Practitioner Regulation National Law deals with the endorsement of registration under the Law.

Medicines, Poisons and Therapeutic Goods Act 2012 44 (2) The health practitioner may, in the course of practising in the health practitioner's health profession, deal with the Scheduled substance in accordance with the endorsed qualification. (3) The health practitioner's authorisation under subsection (2) is subject to the conditions or other restrictions prescribed by

74 Veterinarians (1) A veterinarian may, in the course of providing veterinary services, deal with Scheduled substances as follows: (a) supply or administer a Schedule 3, 4 or 8 substance for the treatment of animals; (b) possess the substance for the purpose mentioned in (2) However, the veterinarian must deal with the substance in accordance with the conditions of the veterinarian's registration.

75 Supplying and administering Schedule 3 substance supplied by health practitioner (1) If a health practitioner has supplied a Schedule 3 substance to a person (the recipient) for use by a person other than the recipient, the recipient may supply, but not sell, the substance to the person. (2) If a health practitioner has supplied a Schedule 3 substance for administration to a person (the patient), any person may administer the substance to the patient in accordance with the instructions given by the health practitioner. Note for subsection (2) See section 71 in relation to the supply of a Schedule 3 substance by a health practitioner.

76 Possessing and administering lawfully supplied Schedule 4 and 8 substances for administering to patients (1) This section applies if, under this Act or an Act of the Commonwealth, a State or another Territory, a health practitioner supplies a Schedule 4 or 8 substance for administering to a person (the patient).

Medicines, Poisons and Therapeutic Goods Act 2012 45 (2) The patient may: (a) self-administer the supplied substance in accordance with the instructions of the health practitioner; and (b) possess the supplied substance for self-administration. (3) In addition, another person may: (a) administer the supplied substance to the patient in accordance with the instructions of the health practitioner; and (b) possess the supplied substance for administering to the patient. Example of application of subsection (3) A doctor issues a prescription for the supply of a restricted Schedule 4 substance for administering to an elderly patient. A child or carer of the patient does not commit an offence against section 41(1) merely because the child or carer administers the substance to the patient in accordance with the doctor's instructions.

77 Possessing and administering lawfully supplied Schedule 4 and 8 substances for administering to animals (1) This section applies if, under this Act or an Act of the Commonwealth, a State or another Territory, a pharmacist or veterinarian supplies a Schedule 4 or 8 substance for administering to animals under a person's control. (2) The person may: (a) administer the supplied substance to the animals in accordance with the instructions of the pharmacist or veterinarian who authorised the supply; and (b) possess the supplied substance for administering it to the (3) However, subsection (2) does not apply to the administration of the supplied substance by the pharmacist or veterinarian. veterinarian includes a person registered or otherwise authorised under an Act of a State or another Territory to provide veterinary services.

Medicines, Poisons and Therapeutic Goods Act 2012 46

78 Possessing, supplying and administering Schedule 3, 4 and 8 substances under emergency authorisation While an emergency authorisation is in force under section 251, a person who is authorised, or a member of a class of health practitioners that is authorised, under the authorisation may, in accordance with the authorisation: (a) supply or administer the Schedule 3, 4 or 8 substances stated in the authorisation; and (b) possess the substances for those purposes.

79 Possessing Scheduled substances for delivery (1) This section applies to a person (the delivery person) who is: (a) engaged by an authorised supplier to transport and deliver a Scheduled substance to someone who is authorised under this Act to possess the substance (the recipient); or (b) an employee or agent of a person mentioned in paragraph (a). Examples of delivery person for subsection (1) 1 A hospital employee. 2 An employee of a courier service. (2) The delivery person is authorised to: (a) possess the Scheduled substance for transporting and delivering it to the recipient in accordance with the delivery person's engagement by the authorised supplier; and (b) supply the substance to the recipient or recipient's employee or agent. Example of agent for subsection (2)(b) The guardian of a child for a substance supplied for administering to the child on a prescription issued by an authorised prescriber. authorised supplier, for a Scheduled substance, means: (a) a person authorised to supply the substance under: (i) Part 2.3 or a regulation; or

Medicines, Poisons and Therapeutic Goods Act 2012 47 (ii) an Act of the Commonwealth, a State or another Territory; or (b) the holder of an authority authorised to supply the substance.

80 Possessing Scheduled substances for destruction (1) This section applies to a waste disposer who is engaged by a person authorised under this Act to possess a Scheduled substance (the authorised person) to destroy the substance. (2) The waste disposer is authorised to possess the Scheduled substance for its destruction in accordance with the waste disposer's engagement by the authorised person. (3) However, the authorisation to possess the Scheduled substance has effect only for as long as is reasonably practicable for the waste disposer to destroy it after receiving it. waste disposer means the holder of a licence under the Waste Management and Pollution Control Act 1998 for disposing of a Scheduled substance that is a listed waste under that Act. Part 2.4 Prescriptions and orders for Schedule 4 and 8

81 Unrestricted Schedule 4 substance unrestricted Schedule 4 substance unless: (i) is a dentist, doctor, endorsed midwife, nurse practitioner, optometrist or podiatrist or another health practitioner person's health profession; or

Medicines, Poisons and Therapeutic Goods Act 2012 48

82 Restricted Schedule 4 substance (1) A person must not issue a prescription for the supply of a restricted Schedule 4 substance unless: (i) is an authorised health practitioner; and person's health profession in accordance with the conditions stated in the declaration of the substance as a restricted Schedule 4 substance; or

83 Unrestricted Schedule 8 substance – general unrestricted Schedule 8 substance unless: (i) is a dentist, doctor, endorsed midwife or nurse practitioner, podiatrist or another health practitioner person's health profession; or

Medicines, Poisons and Therapeutic Goods Act 2012 49

84 Unrestricted Schedule 8 substance – prohibited circumstances unrestricted Schedule 8 substance in a prohibited circumstance mentioned in subsection (2) unless the person: (a) is an authorised health practitioner; and (b) issues the prescription: (i) under a Schedule 8 authorisation or Schedule 8 exemption; and (ii) in the course of practising the health practitioner's health profession. (2) Each of the following is a prohibited circumstance for issuing the prescription: (b) for treating a person's addiction to a substance; (c) for another purpose prescribed by regulation. Note for section 84 Section 139(1) provides that the CHO may, on application, authorise the supply, administration or the issue of a prescription for the supply of an unrestricted Schedule 8 substance in a prohibited circumstance. 85 Restricted Schedule 8 substance (1) A person must not issue a prescription for the supply of a restricted Schedule 8 substance unless: (i) is an authorised health practitioner; and

Subdivision 3 Additional qualifications for health practitioners under Health Practitioner Medicines, Poisons and Therapeutic Goods Act 2012 50 person's health profession under a Schedule 8 authorisation, or Schedule 8 exemption, for an authorised purpose; or Note for subsection (1)(a) Under section 139(1)(c), a Schedule 8 authorisation for the issue of a prescription for the supply of a restricted Schedule 8 substance may be issued only to an authorised health practitioner for administration for an authorised purpose. In addition, under section 245, the CHO may issue a Schedule 8 exemption to an authorised health practitioner for the issue of a prescription for the supply of a restricted Schedule 8 substance for administration for an authorised purpose. Subdivision 3 Additional qualifications for health practitioners under Health Practitioner Regulation National Law

86 Endorsement on health practitioner's registration for additional qualifications (1) This section applies to a health practitioner whose registration under the Health Practitioner Regulation National Law is endorsed as qualified to issue a prescription for the supply of a Scheduled substance (the endorsed qualification) in addition to an authorisation under Subdivision 1 or 2. Part 7, Division 3 of the Health Practitioner Regulation National Law deals with the endorsement of registration under the Law. (2) The health practitioner may, in the course of practising in the health practitioner's health profession, issue a prescription for the supply of the Scheduled substance in accordance with the endorsed qualification.

Medicines, Poisons and Therapeutic Goods Act 2012 51 (3) The health practitioner's authorisation under subsection (2) is subject to the conditions or other restrictions prescribed by Note for section 86 A health practitioner may also issue a prescription for a Schedule 3 substance, the cost of which is subsidised under the Australian Government's Pharmaceutical Benefits Scheme.

87 Requirements for prescription (1) An authorised prescriber must not issue a prescription for a Scheduled substance unless the issue of the prescription complies with: (a) the requirements prescribed by regulation; and (b) for a Schedule 8 substance or restricted Schedule 4 substance – the requirements prescribed by a code of practice.

88 Duration of prescription A prescription issued under this Part for the supply of a Scheduled substance remains in force for the following period from the date it is issued: (a) if it is for supplying a Schedule 8 substance – 6 months or, if a shorter period is prescribed by a code of practice, the shorter period; (b) if it is for supplying another substance – 12 months.

89 Issuing prescription to patient (1) An authorised prescriber commits an offence if the prescriber: (a) issues a prescription for the supply of a Schedule 4 or 8 substance for administering to a person (the patient) for the patient's therapeutic use or treating a medical condition of the patient; and

Medicines, Poisons and Therapeutic Goods Act 2012 52 (b) gives the prescription to a person (the recipient) other than: (i) the patient; or (ii) a carer of the patient; or (iii) a guardian of the patient; or (iv) a prescribed person. (2) Subsection (1) does not apply if: (a) the patient is the partner of the recipient; and (b) the substance is a Schedule 4 substance for treating the partner for the medical condition of chlamydia; and (c) the prescribed conditions apply to the issue of the prescription. (3) In addition, the authorised prescriber is not civilly liable in relation to the issue of the prescription. (4) Without limiting subsection (3), issuing and giving the prescription does not constitute a breach of professional etiquette or ethics or a departure from accepted standards of professional conduct. carer, see section 5 of the Carer's Recognition Act 2006. partner, of a person, includes: (a) the person's spouse; and (b) the person's de facto partner; and (c) someone with whom the person is in a sexual relationship. prescribed means prescribed by regulation.

90 No self-prescription of Schedule 8 or restricted Schedule 4 An authorised prescriber must not issue to himself or herself a prescription for the supply of a Schedule 8 substance or restricted

Division 3 Orders for administering and supplying Schedule 4 and 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 53

91 Quantity of Schedule 8 substance authorised by prescription (1) An authorised prescriber must not issue a prescription for the supply of a Schedule 8 substance for more than: (a) 3 months supply of the substance administered at the daily dose recommended by the authorised prescriber; or (b) if a greater quantity is prescribed by a code that applies to the issue of the prescription – that quantity. Division 3 Orders for administering and supplying Schedule 4 and 8 substances

92 Authorised prescriber may authorise administration and supply by order (1) An authorised prescriber for a Scheduled substance may: (a) by written or oral order (an administration order), authorise the administration of the substance by an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist to: (i) a patient of a hospital; or (ii) a resident at a residential facility; or (iii) a person receiving medical treatment at a declared place; or (iv) a person receiving palliative care at the person's residence in a circumstance prescribed by regulation; or (b) by written order (a supply order), authorise the supply of the substance by a pharmacist to: (i) a person on the person's discharge as a patient of a hospital; or (ii) the nurse employed at a residential facility for administration to a resident at the facility; or (iii) the person in charge of a declared place.

Part 2.5 Special provisions about supplies of Schedule 4 and 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 54 (2) An administration order or supply order must comply with the requirements prescribed by regulation. Note for section 92 An administration order or supply order may be issued electronically in accordance with the Electronic Transactions (Northern Territory) Act 2000. Part 2.5 Special provisions about supplies of

93 Supply of Schedule 4 and 8 substances on prescription (1) A pharmacist who supplies a Schedule 4 or 8 substance on a prescription must write the date of the supply on the prescription. (2) A pharmacist must not supply a Schedule 4 or 8 substance on a prescription that is not in force when the substance is supplied. (3) An offence against subsection (1) or (2) is an offence of strict subsection (1) or (2) if the defendant establishes a reasonable Note for section 93 In some circumstances, a pharmacist may supply a Schedule 4 or 8 substance without a prescription under sections 59 to 61.

94 Repeat supply of Schedule 8 substance (1) A pharmacist commits an offence if: (a) an authorised prescriber issues a repeat prescription for the supply of a Schedule 8 substance; and (b) the pharmacist supplies the substance within the minimum repeat interval for the prescription. (2) Subsection (1) does not apply if the pharmacist is satisfied: (a) the previous supply of the substance was lost, stolen or destroyed; or

Part 2.5 Special provisions about supplies of Schedule 4 and 8 substances Medicines, Poisons and Therapeutic Goods Act 2012 55 (b) the supply is urgently needed to treat the person to whom the substance is supplied; or (c) other circumstances prescribed by a code of practice apply to the supply.

95 Health practitioner to ensure self-administration of some supplied Schedule 8 substances (1) This section applies to a health practitioner: (a) supplying a prescribed Schedule 8 substance under a Schedule 8 authorisation or Schedule 8 exemption; or (b) a health practitioner who is a pharmacist supplying a prescribed Schedule 8 substance on a prescription issued by an authorised prescriber. (2) The health practitioner must ensure the person to whom the substance is supplied self-administers the substance in the health practitioner's presence. (4) Subsection (2) does not apply if, under a code of practice, takeaway doses of the substance are authorised for the person. subsection (2) if the defendant establishes a reasonable excuse. (6) In this section: prescribed Schedule 8 substance means a Schedule 8 substance prescribed by a code of practice for this section.

96 Pharmacist to give CHO prescription for supply of Schedule 8 (1) A pharmacist who supplies a Schedule 8 substance or restricted Schedule 4 substance on a prescription must, within 7 days after the supply, give the CHO: (a) if the prescription is a repeat prescription that authorises supply on a later occasion – a copy of the prescription; or (b) otherwise – the prescription on which the pharmacist supplied

Medicines, Poisons and Therapeutic Goods Act 2012 56 (1A) Subsection (1) does not apply in relation to the supply of a monitored medicine for administration to a person. Note for subsection (1A) Section 243E(1)(b) requires information to be given by a pharmacist in relation to the supply of a monitored medicine for administration to a person.

97 Obligations of authorised prescriber and pharmacist for supply made without prescription in emergency (1) This section applies if, under section 61, a pharmacist supplies a Schedule 4 or 8 substance to a person at the request of an authorised prescriber. (2) The authorised prescriber must give the pharmacist a prescription for the supply within 7 days after making the request. (3) If the pharmacist does not receive a prescription for the supply of the substance on the request within 7 days after the supply, the pharmacist must give a written report about the supply to the CHO. (4) An offence against subsection (2) or (3) is an offence of strict subsection (2) or (3) if the defendant establishes a reasonable Part 2.6 Special provisions about dealing with Scheduled substances in hospitals, residential facilities and declared places

98 Storage at hospital (1) The manager of a hospital must: (a) ensure all Scheduled substances received at the hospital are stored in an area and in a way to prevent unauthorised access to them; and

Medicines, Poisons and Therapeutic Goods Act 2012 57 (b) take reasonable measures to prevent unauthorised access at any time to the substances.

99 Administering Schedule 3, 4 or 8 substance at hospital, residential facility or declared place (a) a health practitioner is practising in the health practitioner's health profession at a hospital, residential facility or declared place; and (b) in the course of practising the health profession, the health practitioner: (i) is supplied a Schedule 3 substance; or (ii) is supplied a Schedule 4 or 8 substance on a prescription or supply order of an authorised prescriber for the substance; and (c) the substance is supplied for administering to a patient of the hospital, resident at the residential facility or person receiving medical treatment at the declared place (the relevant patient). (2) The health practitioner commits an offence if the health practitioner: (a) knows the supplied substance is a Schedule 3, 4 or 8 (b) administers the substance to the relevant patient; and (c) does not administer the substance in accordance with the instructions of the authorised prescriber. (3) The health practitioner commits an offence if the health practitioner: (a) knows the supplied substance is a Schedule 3, 4 or 8 (b) administers the substance to a person; and

Medicines, Poisons and Therapeutic Goods Act 2012 58 (c) knows the person is not the relevant patient. Maximum penalty: 200 penalty units.

100 Administration or supply of Schedule 8 substance to be witnessed (1) Subject to subsections (3) and (4), a health practitioner must not administer or supply a Schedule 8 substance to a relevant patient unless a person other than the practitioner or the patient witnesses the administration or supply of the substance. (2) Subject to subsections (3) and (4), if a health practitioner administers or supplies a Schedule 8 substance to a relevant patient and the administration or supply of the substance is witnessed by another person, the health practitioner must record the name of at least one person who witnessed the administration or supply of the substance in the record prescribed by regulation (the prescribed record). (3) Subsections (1) and (2) do not apply to a health practitioner if: (a) the health practitioner is an Aboriginal and Torres Strait Islander health practitioner, a nurse, a midwife or a pharmacist (the practitioner); and (b) another person is not reasonably available to witness the practitioner administer or supply the Schedule 8 substance to the relevant patient because of: (i) the remote location of the place where the substance is administered or supplied; or (ii) other special circumstances; and (c) the practitioner records the reason why the administration or supply of the substance was not witnessed in the relevant patient's clinical record. (4) Subsection (1) and (2) do not apply to a health practitioner if: (a) the health practitioner is a pharmacist; and (b) the Schedule 8 substance that is administered or supplied to the relevant patient by the pharmacist is a restricted Schedule 8 substance; and

Medicines, Poisons and Therapeutic Goods Act 2012 59 (c) the relevant patient is taking part in a pharmacotherapy program conducted at the hospital, residential facility or declared place. (5) A health practitioner commits an offence if: (a) the health practitioner administers or supplies a Schedule 8 substance to a relevant patient; and (b) the administration or supply of the substance is required to be witnessed under subsection (1); and (c) the administration or supply of the substance is not witnessed by a person other than the health practitioner or the relevant patient. (6) A health practitioner commits an offence if: (a) the health practitioner administers or supplies a Schedule 8 substance to a relevant patient; and (b) the administration or supply of the substance is witnessed by a person other than the health practitioner or the relevant patient; and (c) the health practitioner is required to record the name of at least one of the persons who witnessed the administration or supply of the substance in the prescribed record under subsection (2); and (d) the health practitioner fails to record the name of at least one of the persons who witnessed the administration or supply of the substance in the prescribed record. (7) An offence against subsection (5) or (6) is an offence of strict (8) In this section: relevant patient means a person who is: (a) a patient of a hospital; or (b) a resident of a residential facility; or (c) receiving medical treatment at a declared place.

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101 Packaging supplied Scheduled substances (a) the person is authorised under this Act to supply a Scheduled substance to another person; and (b) the person supplies the substance to another person; and (c) the substance is not packaged as prescribed by regulation. (2) Subsection (1) does not apply if the substance is supplied for immediately administering to a person.

102 Labelling supplied Scheduled substances (a) the person is authorised under this Act to supply a Scheduled substance to another person; and (b) the person supplies the substance to another person; and (c) the container of the substance is not labelled as prescribed by (2) Subsection (1) does not apply if the substance is supplied for immediately administering to a person.

103 Permanently marked containers – use for other Scheduled (a) the person uses a container for storing a Scheduled

Medicines, Poisons and Therapeutic Goods Act 2012 61 (b) the container is permanently marked with the name of a different Scheduled substance.

104 Scheduled substance container not to be used for human-use (a) the person supplies a human-use substance in a container; and (b) the container is of a kind of container prescribed by regulation that has been used for storing a Scheduled substance. human-use substance means any of the following substances: (a) food; (b) a drink; (c) a condiment.

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105 Definitions manufacturer's pack, of an unscheduled substance, means a primary pack of the substance that has been packaged and labelled by the substance's manufacturer in compliance with the medicines and poisons standard. Note A primary pack is a pack in which a substance and its immediate container or immediate wrapper or measure pack are presented for sale or supply (see the medicines and poisons standard). unscheduled substance means a substance mentioned in Schedule 2, 3, 4 or 8 to the medicines and poisons standard if none of the Schedules apply to the substance because of an exception in the standard. Example Aspirin is mentioned in several Schedules of the medicines and poisons standard but in small packages is an unscheduled substance. vending machine means a machine or device from which a Scheduled substance can be obtained, including by one or more of the following: (a) electronic funds transfer; (b) inserting money, a token or something else. Examples of other things for paragraph (b) 1 A credit card. 2 A debit card. 3 A key. 106 Vending machine supplies of unscheduled substances (a) the person is the occupier of premises; and (b) a vending machine is installed on the premises; and

Medicines, Poisons and Therapeutic Goods Act 2012 63 (c) the vending machine is used, or available for use, for supplying an unscheduled substance. (2) Strict liability applies to subsection (1)(a) and (b). (3) Subsection (1) does not apply if the vending machine was placed on the premises without the occupier's consent. (4) In addition, subsection (1) does not apply if: (a) the unscheduled substance is supplied in a manufacturer's pack containing not more than 2 adult doses of the substance; and (b) the substance was packed in the manufacturer's pack by the manufacturer of the substance; and (c) the vending machine is presented and located in a way that makes unsupervised access by children unlikely. Division 3 Methylated spirit 107 Drinking methylated spirit (1) A person must not drink a methylated spirit. 108 Supplying methylated spirit for drinking A person must not supply a methylated spirit to another person for drinking by the other person or someone else.

110 Manufacture, supply and use of first, second and third schedule paints (1) A person commits an offence if the person manufactures, supplies or uses a first schedule paint as prescribed by regulation. Maximum penalty: 40 penalty units.

Medicines, Poisons and Therapeutic Goods Act 2012 64 (2) A person commits an offence if the person manufactures, supplies or uses a second schedule paint as prescribed by regulation. (3) A person commits an offence if the person manufactures, supplies or uses a third schedule paint. Note for section 110 Paragraph 6 of Part 1 of the medicines and poisons standard defines the paints to which this section applies.

111 Manufacture, supply and use of paints for toys (a) the person manufactures a paint with the intention the paint be applied to toys; and (b) the paint does not comply with the requirements prescribed by (a) the person supplies a paint; and (b) knows the paint is to be applied to toys; and (c) the paint does not comply with the requirements prescribed by (3) A person commits an offence if: (a) the person applies a paint to toys; and (b) the paint does not comply with the requirements prescribed by

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112 Manufacture, supply and use of paints containing pesticides A person commits an offence if: (a) the person manufactures, supplies or uses a paint containing a pesticide; and (b) the pesticide is not prescribed by regulation.

112A Definition pest authorisation means: (a) a pest management technician licence; or (b) a licence granted under Part 5, Division 2 of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004; or (c) an S7 authorisation issued under the Agricultural and Veterinary Chemicals (Control of Use) Regulations 2005.

112B Representation by unauthorised person (a) represents, by any means, that the person carries out pest control operations involving the use of a pesticide for fee or reward; and (b) is not authorised under a pest authorisation to use the pesticide.

112C Advertisement to include authorisation number (1) An advertisement for pest control operations that are offered by a business and involve the use of a pesticide must state: (a) if the owner of the business holds a pest authorisation – the number of that authorisation; or

Medicines, Poisons and Therapeutic Goods Act 2012 66 (b) otherwise – the number of the pest authorisation held by at least one person who is employed or contracted by the owner to carry out pest control operations for the business. (i) places or distributes an advertisement for pest control operations that are offered by a business and involve the use of a pesticide; or (ii) authorises another person to place or distribute an advertisement mentioned in subparagraph (i); and (b) the advertisement does not state the information required under subsection (1). advertisement means every form of advertisement or notice, however displayed, and whether or not displayed to the public. Examples for definition advertisement 1 A post on a social media platform. 2 A flyer on a noticeboard. 113 Advertising some Scheduled substances (a) the person publishes an advertisement; and (b) the advertisement promotes or encourages the use of a prescribed substance. (a) the person publishes an advertisement; and

Medicines, Poisons and Therapeutic Goods Act 2012 67 (b) the advertisement indicates someone is willing or authorised under this Act to supply a prescribed substance. (3) Subsections (1) and (2) do not apply to: (a) an advertisement for a prescribed substance in a publication published primarily for health practitioners or veterinarians; or (b) an advertisement prescribed by regulation. advertisement, for a prescribed substance, means writing, sound or a picture, symbol, light or other visible device, object or sign (or a combination of 2 or more of them) that a reasonable person would consider publicises, or otherwise promotes, the purchase or use of prescribed substance means: (a) a Schedule 3 substance other than a Schedule 3 substance to which Appendix H to the medicines and poisons standard applies; or (b) a Schedule 4, 8 or 9 substance.

114 No self-administration of Schedule 8 or restricted Schedule 4 (1) A person who is authorised under this Act to supply a Schedule 8 substance or restricted Schedule 4 substance must not self-administer the substance. (2) Subsection (1) does not apply if the substance has been supplied to the person for self-administration by someone else who is authorised under this Act to do so (an authorised person).

Medicines, Poisons and Therapeutic Goods Act 2012 68 (3) In addition, it is a defence to a prosecution for an offence against subsection (1) if the defendant proves: (a) the defendant: (i) self-administered the substance for a genuine therapeutic use in an emergency and had no access to an authorised person to administer the substance; and (ii) gives notice of the administration in the approved form to the CHO within 7 days after the administration; or (b) the defendant self-administered the substance under another circumstance prescribed by regulation.

115 Temporary prohibition on dealing with substance (1) This section applies if the CHO is satisfied, because of urgent circumstances, it is necessary to immediately prohibit dealing with a substance to promote or protect public health and safety. (2) The CHO may, by Gazette notice, prohibit the dealing subject to the (3) The notice must state the particulars of the prohibition, including the following: (a) the substance; (b) the kind of dealing prohibited; (c) the reasons for the prohibition; (d) the conditions of the prohibition. (4) A person must not engage in conduct that results in a contravention of the prohibition. (5) The notice has effect despite another provision of this Act. (6) The notice ceases to have effect on the earlier of the following: (a) the date stated in it; (b) 3 months after it commences.

Medicines, Poisons and Therapeutic Goods Act 2012 69 (7) In this section: dealing with, for a substance, means to do any of the things mentioned in section 17(a) to (j) with the substance. substance means a substance mentioned in a Schedule or Appendix to the medicines and poisons standard (whether or not the standard applies to the substance). Note for section 115 Because clause 1(2) of the medicines and poisons standard applies to the interpretation of this Act under section 15(2), a substance includes: (a) a substance prepared from natural sources or artificially; and (b) every salt, active principle or derivative of the substance; and (c) a preparation or admixture containing any proportion of the substance.

116 Prohibition on health practitioner or veterinarian dealing with Schedule 8 substance (1) If the CHO considers a health practitioner or veterinarian should be prohibited from dealing with Schedule 8 substances, or a particular Schedule 8 substance, the CHO may give the health practitioner or veterinarian written notice stating: (a) the particulars of the proposed prohibition, including its duration; and (b) the reasons for the proposed prohibition; and (c) the health practitioner or veterinarian may, within the period stated in the notice, make written representations to the CHO objecting to the proposed prohibition. (2) After the end of the period stated in the notice, the CHO may, by written notice (the prohibition notice), prohibit the health practitioner or veterinarian from dealing with Schedule 8 substances, or a stated Schedule 8 substance, as stated in the (3) The prohibition notice may be subject to stated conditions. Example for subsection (3) The prohibition may state a place from where a pharmacist may store a substance to enable the pharmacist to supply it on a prescription issued by an authorised prescriber. (4) In deciding whether to give the prohibition notice, the CHO must have regard to written submissions made by the health practitioner or veterinarian before the end of the period.

Medicines, Poisons and Therapeutic Goods Act 2012 70 (5) The prohibition notice must include an information notice for the (6) The health practitioner or veterinarian must not engage in conduct that results in a contravention of the prohibition notice. (7) The notice has effect despite another provision of this Act.

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117 Types of authorities Each of the following is an authority issued by the CHO: (a) a manufacturer certificate of registration; (b) a wholesaler certificate of registration; (ba) a Schedule 4 supplier certificate of registration; (c) a retailer licence; (ca) a Schedule 3 authorisation; (d) a Schedule 4 authorisation; (e) a Schedule 7 authorisation; (f) a pest management technician licence; (g) a Schedule 8 authorisation; (h) a prohibited substance authorisation; (i) a research authorisation; (j) a medical kit authorisation.

118 Suitability of authority holder – individuals (1) In deciding whether an individual (other than a health practitioner) is a suitable person to hold an authority, the CHO must have regard to the following: (a) the knowledge, experience and qualifications of the individual in relation to the Scheduled substances to which the authority relates; (b) the dealings with Scheduled substances to which the authority relates and the purpose of the dealings; (c) another matter prescribed by regulation.

Medicines, Poisons and Therapeutic Goods Act 2012 72 (2) However, an individual is not a suitable person to hold an authority if: (a) the individual has been convicted or found guilty of any of the following in the 5-year period before the day the application for the authority is made: (i) an offence against this Act; (ii) an offence in Australia or elsewhere in relation to a Scheduled substance; or (b) the individual at any time in the 5-year period before the day the application for the authority is made: (i) was an undischarged bankrupt; or (ii) executed a personal insolvency agreement; or (c) at any time in the 5-year period before the day the application for the authority is made, the individual was involved in the management of a body corporate when: (i) the body corporate became the subject of a winding-up order; or (ii) an administrator was appointed for the body corporate; or (d) a circumstance prescribed by regulation applies in relation to the individual. (3) Despite subsection (2), the CHO may decide an individual is a suitable person to hold an authority if satisfied: (a) the individual's dealings with Scheduled substances authorised, or to be authorised, by the authority would not be inconsistent with the objects of this Act if the CHO decided that the individual is a suitable person; and (b) it is otherwise in the public interest that the individual be treated as a suitable person.

119 Suitability of authority holder – bodies corporate (1) A body corporate is a suitable person for an authority if: (a) each executive officer of the body corporate is a suitable person to hold the authority; and

Medicines, Poisons and Therapeutic Goods Act 2012 73 (b) the body corporate is not the subject of a winding-up order, and has not been the subject of a winding-up order in the 5-year period before the day the application for the authority is made; and (c) an administrator has not been appointed for the body corporate in the 5-year period before the day the application for the authority is made. (2) However, if a body corporate is not a suitable person for an authority under subsection (1), the CHO may decide the body corporate is a suitable person to hold an authority if satisfied: (a) the body corporate's dealings with Scheduled substances to which the authority relates would not be inconsistent with the objects of this Act if the CHO decided the body corporate is a suitable person; and (b) it is otherwise in the public interest that the body corporate be treated as a suitable person.

120 Suitability of nominated person – certificate of registration An individual is a suitable person to be the nominated person for a certificate of registration if the individual: (a) is a suitable person to hold the authority; and (b) the CHO is satisfied the person is suitable to have control of the business activities or services to be carried out under the authority.

121 Manufacturer certificate of registration A manufacturer certificate of registration, for a place, is an authority that authorises its holder to: (a) manufacture the Scheduled substances stated in the certificate at the place; and (b) supply the manufactured substances from the place in the course of carrying out business activities for the manufacture of the substances; and

Medicines, Poisons and Therapeutic Goods Act 2012 74 (c) possess the substances for a purpose mentioned in Note for section 121 A manufacturer certificate of registration may authorise the manufacture, possession and supply of a dangerous drug that would otherwise be unlawful under Part II, Division 1 of the Misuse of Drugs Act 1990.

122 Wholesaler certificate of registration A wholesaler certificate of registration, for a place, is an authority that authorises its holder to: (a) supply the Scheduled substances stated in the certificate from the place in the course of carrying out business activities for the sale of the substances by wholesale; and (b) possess the substances for a purpose mentioned in

122A Schedule 4 supplier certificate of registration A Schedule 4 supplier certificate of registration, for a place, is an authority that authorises its holder: (a) to supply, but not to sell, the Schedule 4 substances stated in the certificate from the place in the course of carrying out the service of distributing the substances to health practitioners or health services; and (b) to possess the substances for a purpose mentioned in

123 Retailer licence A retailer licence, for a place, is an authority that authorises the licensee to: (a) supply the Schedule 2 and 7 substances stated in it from the place in the course of carrying out business activities for the retail sale of the substances; and (b) possess the substances for a purpose mentioned in Note for section 123 However, under section 145, the licensee is prohibited from supplying a

Schedule 2 substance from the licensed place if it is located within 25 km, by the shortest practical route, of a pharmacy.

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123A Schedule 3 authorisation A Schedule 3 authorisation is an authority that authorises its holder, and the persons stated in it, to supply, but not to sell, the Schedule 3 substances stated in it.

124 Schedule 4 authorisation A Schedule 4 authorisation is an authority that authorises its holder, and the persons stated in it, to do one or more of the following in relation to the Schedule 4 substances stated in it: (a) administer the substances to animals (but not humans) for the purposes stated in it; (b) otherwise use the substances; (c) possess the substances for a purpose mentioned in

125 Schedule 7 authorisation (1) A Schedule 7 authorisation is an authority that authorises its holder to use the Schedule 7 substances (other than a chemical product) stated in it. chemical product, see section 4(1) of the Agricultural and Veterinary Chemicals (Control of Use) Act 2004. Note for subsection (2) The Agricultural and Veterinary Chemicals (Control of Use) Act 2004 provides controls on the use of chemical products. The controls under that Act include, for example, obligations on pharmacists providing information to people about chemical products supplied to them on the prescription of a veterinarian, see section 34 of that Act.

126 Pest management technician licence A pest management technician licence is an authority that authorises the licensee to use the pesticides stated in it for carrying out pest control operations. Note for section 126 Depending on the knowledge, experience and qualifications of the licensee in the use of pesticides, the licence may be subject to conditions about the use of stated pesticides. For example, the licence may authorise use of a pesticide only under the direct supervision of a licensee with additional qualifications.

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127 Schedule 8 authorisation A Schedule 8 authorisation is an authority that authorises its holder to do one or more of the following in relation to the Schedule 8 substances stated in it: (a) supply the substances; (b) administer the substances to another person or to animals; (c) otherwise use the substances; (d) issue a prescription for the supply of the substances; (e) possess the substances for a purpose mentioned in paragraphs (a) to (d). Notes for section 127 1 A Schedule 8 authorisation may authorise the possession, supply or use of a dangerous drug that would otherwise be unlawful under Part II, Division 1 of the Misuse of Drugs Act 1990. 2 Also, see section 139 for restrictions applying in relation to the issue of Schedule 8 authorisations. 128 Prohibited substance authorisation (1) A prohibited substance authorisation issued to an authorised health practitioner (the authority holder) is an authority that authorises the authority holder, and another authorised health practitioner stated in it, to do one or more of the following in relation to the prohibited substance stated in it: (a) administer the substance to the person stated in it; (b) supply the substance to the person stated in it for the person to self-administer; (c) possess the substance for a purpose mentioned in (2) If the authorisation authorises the supply of the substance to the person stated in it for self-administration, the authorisation also authorises the person to: (a) self-administer the substance; and (b) possess the substance to self-administer.

Medicines, Poisons and Therapeutic Goods Act 2012 77 (3) A prohibited substance authorisation issued to a veterinarian or other person prescribed by regulation is an authority that authorises its holder to do the following in relation to the substance: (a) administer the substance to animals; (b) possess the substance for the purpose mentioned in Notes for section 128 1 A prohibited substance authorisation may authorise the possession, supply or use of a dangerous drug that would otherwise be unlawful under Part II, Division 1 of the Misuse of Drugs Act 1990. 2 Also, see section 140 for restrictions applying in relation to prohibited substance authorisations. 129 Research authorisation A research authorisation is an authority that authorises its holder to: (a) administer or supply, but not to sell, Schedule 3 substances to another person; or (b) do one or more of the following in relation to the Schedule 4, 7 and 8 substances, or prohibited substances, stated in it for medical or scientific research: (i) administer the substances to stated persons or to animals; (ii) otherwise use the substances; (iii) possess the substances for a purpose mentioned in subparagraph (i) or (ii). Notes for section 129 1 A research authorisation may authorise the possession, supply or use of a dangerous drug that would otherwise be unlawful under Part II, Division 1 of the Misuse of Drugs Act 1990. 2 Also, see section 141 for restrictions applying in relation to research authorisations.

130 Medical kit authorisation (1) A medical kit authorisation is an authority that authorises its holder, and the other persons stated in it, to: (a) administer or supply, but not to sell, Schedule 3 substances to another person; and

Medicines, Poisons and Therapeutic Goods Act 2012 78 (b) do one or more of the following in relation to the Schedule 4 substances stated in it: (i) supply the substances; (ii) self-administer the substances; (iii) administer the substances to another person; (iv) possess the substances for a purpose mentioned in subparagraphs (i) to (iii). (2) In addition, the authorisation may authorise its holder, and the other persons stated in it, to: (a) administer the Schedule 8 substances stated in it; and (b) possess the substances for that purpose.

131 Making application An application for an authority must: (a) be made to the CHO in the approved form; and (b) be accompanied by sufficient documents and information to enable the CHO to decide the application; and (c) for an application for a certificate of registration – state the name of the individual to have control of the business activities or services to be carried out at the place (the nominated person).

132 CHO may require further information The CHO may, by written notice, require the applicant to give the CHO further documents or information, within the reasonable period stated in the notice, for considering and deciding the application.

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133 CHO to give application for Schedule 8 authorisation to If the application is for a Schedule 8 authorisation for a restricted Schedule 8 substance, the CHO must give the application and all documents and information in support of it to the Committee for its advice. Note for section 133 Under section 139(5), the CHO may issue a Schedule 8 authorisation to the applicant without considering the Committee's advice if the circumstances prescribed by regulation apply.

134 Considering and deciding application (1) The CHO must consider the application and either issue, or refuse to issue, the authority sought. (2) The CHO must issue the authority if satisfied: (a) no restriction on the issue of the authority under Division 2, or prescribed by regulation, applies in relation to the application; and (b) the applicant can comply with this Act in relation to the Scheduled substances to which the application relates; and (c) the substances are to be stored in an area and in a way to prevent unauthorised access to them; and (d) if the application is for a certificate of registration – the proposed nominated person stated in the application is a suitable person; and (e) if the application is made by a person who is not a health practitioner – the applicant is a suitable person to hold the authority. Note about storage of Scheduled substances for subsection (2)(c) In addition, the CHO must be satisfied about security arrangements for some places where Scheduled substances are stored, see sections 135(b), 136(b), 136A(1)(b), 140(1)(f) and 141(1)(e). (3) The CHO must refuse to issue the authority if the CHO is not satisfied about the matters mentioned in subsection (2).

Medicines, Poisons and Therapeutic Goods Act 2012 80 (4) In addition, the CHO may refuse to issue a Schedule 7 authorisation or pest management technician licence if satisfied about the matter mentioned in section 172(4). Note for subsection (4) Under section 172(4)(a), the CHO may refuse to issue a Schedule 7 authorisation or pest management technician licence if satisfied a medical examination indicates the applicant's use or continued use of Schedule 7 substances or pesticides is a threat to the applicant's health.

135 Certificate of registration The CHO may issue a certificate of registration only if satisfied, having regard to the nature of the business activities or services to be carried out and the Scheduled substances involved: (a) the place to which the application relates is suitable: (i) for a manufacturer certificate of registration – for manufacturing and storing the Scheduled substances; or (ii) for a wholesaler certificate of registration or Schedule 4 supplier certificate of registration – for storing the Scheduled substances; and (b) security arrangements for the place are adequate to prevent the unlawful use or removal of the substances from the place.

136 Retailer licence The CHO may issue a retailer licence only if satisfied: (a) the place to which the application relates: (i) is suitable for storing Scheduled substances for supply; and (ii) constitutes one retail outlet only; and (b) security arrangements for the place are adequate to prevent the unlawful use or removal of the substances from the place.

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136A Schedule 3 authorisation (1) The CHO may issue a Schedule 3 authorisation for a Schedule 3 substance only if satisfied that: (a) the applicant, and each person to be authorised under the authority to supply the substance, is competent to: (i) safely handle the substance; and (ii) give instructions for the safe use of the substance when supplying it; and (b) the security arrangements for the place where the substances are to be stored by the applicant are adequate to prevent the unlawful use or removal of the substances from the place. (2) In considering the matters referred to in subsection (1)(a), the CHO may have regard to: (a) the applicant's proposed policies or guidelines for supplying the substance; and (b) whether the applicant, and each person to be authorised under the authority to supply the substance, have any appropriate training, experience or qualifications for supplying

137 Schedule 4 authorisation The CHO may issue a Schedule 4 authorisation only if satisfied the intended use of a Schedule 4 substance is an authorised purpose. Note for section 137 For authorised purposes for Schedule 4 substances, see paragraph (a) of the definition authorised purpose in section 5.

138 Pest management technician licence The CHO may issue a pest management technician licence only to an individual.

139 Schedule 8 authorisation (1) The CHO may issue a Schedule 8 authorisation that authorises any of the following only if satisfied the applicant is an authorised health practitioner: (a) the supply or administration of an unrestricted Schedule 8 substance in a prohibited circumstance;

Medicines, Poisons and Therapeutic Goods Act 2012 82 (b) the supply or administration of a restricted Schedule 8 substance for an authorised purpose and possession of the substance for that purpose; (c) the issue of a prescription for the supply of: (i) an unrestricted Schedule 8 substance in a prohibited circumstance; or (ii) a restricted Schedule 8 substance for an authorised purpose. Note for subsection (1)(a) and (c)(i) For prohibited circumstances for the supply or administration, or the issue of a prescription for the supply, of an unrestricted Schedule 8 substance, see sections 48(2) and 84(2). Note for subsection (1)(b) and (c)(ii) For authorised purposes for restricted Schedule 8 substances, see paragraphs (b) and (c) of the definition authorised purpose in section 5. (2) In addition, the CHO may issue a Schedule 8 authorisation that authorises the supply of a restricted Schedule 8 substance to a person for self-administration for an authorised purpose only if satisfied: (a) it is not reasonably practicable in the circumstances for the substance to be administered by an authorised health practitioner; and (b) the person is competent to properly self-administer the (3) Otherwise, the CHO may issue a Schedule 8 authorisation for a Schedule 8 substance only if satisfied the intended use of the substance is an authorised purpose. (4) The CHO must consider the Committee's advice before issuing a Schedule 8 authorisation mentioned in subsection (2). (5) However, if the circumstances prescribed by regulation apply, the CHO may issue a Schedule 8 authorisation mentioned in subsection (2) without considering the Committee's advice.

140 Prohibited substance authorisation (1) The CHO may issue a prohibited substance authorisation for a prohibited substance only in the circumstances mentioned in subsection (2) or (3).

Medicines, Poisons and Therapeutic Goods Act 2012 83 (2) The CHO may issue a prohibited substance authorisation for a prohibited substance if satisfied: (a) the applicant is an authorised health practitioner; and (b) a person is suffering an illness for which there is a therapeutic need for treatment with the substance; and (c) the substance is to be: (i) administered to the person by the applicant or another authorised health practitioner to treat the illness; or (ii) self-administered by the person to treat the illness; and (d) the administration of the substance is justified in the circumstances because the person is suffering from symptoms unresponsive to other available treatment; and (e) if the substance is to be self-administered: (i) it is not reasonably practicable in the circumstances for the substance to be administered by an authorised health practitioner; and (ii) the person is competent to properly self-administer the (f) security arrangements for the place where the substance is to be stored are adequate to prevent the unlawful use or removal of the substance from the place. (3) The CHO may issue a prohibited substance authorisation for a prohibited substance if satisfied: (a) the applicant is a veterinarian or other person prescribed by regulation; and (b) the substance is for use to sedate animals or for another use (c) security arrangements for the place where the substance is to be stored are adequate to prevent the unlawful use or removal of the substance from the place.

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141 Research authorisation (1) The CHO may issue a research authorisation for a Schedule 3, 4 or 8 substance, or a prohibited substance, for medical or scientific research only if satisfied: (a) the research has merit and is justified; and (b) the research is to be conducted or supervised by persons with experience, qualifications and competence that are appropriate for the research; and (c) the research is to be conducted using facilities and resources appropriate for the research; and (d) the research cannot be carried out without the use of the (e) security arrangements for the place where the research is to be conducted are adequate to prevent the unlawful use or removal of the substance from the place. (2) In deciding whether the research has merit and is justified, the CHO must take into account the following: (a) the scope and objectives of the research; (b) the potential benefits or predicted value to be gained by the research; (c) if the research involves participation by humans: (i) ethical considerations; and (ii) the risk of potential harm to the participants, their families and the community at large, including, for example, the kind of harm, the likelihood of the harm occurring and the severity of the harm; (d) if the research involves the use of animals: (i) ethical considerations; and (ii) the potential effects on the welfare of the animals. Note for section 141 Other legislation may apply to the medical or scientific research for which the application is made, for example, the National Health and Medical Research Council Act 1992 (Cth). Under that Act, guidelines are issued on matters relating to public health research and medical research.

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142 Medical kit authorisation The CHO may issue a medical kit authorisation for Scheduled substances only if satisfied: (a) the professional advice or personal attendance of a health practitioner is not always reasonably available before administering the substances; and (b) the applicant, and each person to be authorised under the authority to administer the substances, are competent to safely handle and administer the substances. Examples of circumstances for issue of medical kit authorisation 1 The applicant is the lessee of a pastoral or mining lease where the substances are to be kept to treat medical problems that may arise. 2 The substances are to be kept on an ocean-going boat to treat medical problems that may arise while at sea. 3 The substances are for use at a cyclone shelter to treat medical problems that may arise during an emergency. 143 Conditions – general (1) An authority is subject to: (a) the conditions stated in this Division for the authority; and (b) the other conditions prescribed by: (i) regulation; or (ii) for a Schedule 8 substance or restricted Schedule 4 substance – a code of practice. Examples of conditions for subsection (1)(b) 1 The quantity, form and strength of a Scheduled substance authorised to be used under an authority. 2 A limit in relation to the persons: (a) to whom the Scheduled substance can be supplied or administered under the authority; and (b) for whom prescriptions can be issued under the authority.

Medicines, Poisons and Therapeutic Goods Act 2012 86 (2) In addition, the CHO may issue the authority subject to the reasonable conditions stated in it. Example of condition for subsection (2) A pest management technician licence may be subject to the condition that its holder may carry out pest control operations only under the direct supervision of another pest management technician licensee who is the holder's employer. (3) Without limiting subsection (2), conditions may be imposed about compliance with a stated code of practice applicable to activities under the authority.

144 Conditions – certificate of registration A certificate of registration for a Scheduled substance is subject to the following conditions: (a) its holder may supply the substance only to: (i) a health practitioner or veterinarian authorised under this Act to possess the substance; or (ii) the holder of an authority to possess the substance; or (iii) the person in charge of a declared place; or (iv) a person authorised to possess the substance under another law in force in the Territory; or (b) its holder must deal with the substance in accordance with the code of conduct, or other document, prescribed by regulation.

145 Conditions – retailer licence A retailer licence is subject to the condition that the licensee must not supply a Schedule 2 substance from the licensed place if it is located within 25 km, by the shortest practical route, of a pharmacy.

145A Conditions – Schedule 3 authorisation (1) A Schedule 3 authorisation is subject to the condition that an authorised person who supplies a Schedule 3 substance to another person under the authority must, at the time of the supply, give the person adequate instructions (written or oral) for the use of the (2) The regulations may provide for matters relating to the content of the instructions that are required to be given in accordance with the condition imposed by subsection (1).

Medicines, Poisons and Therapeutic Goods Act 2012 87 authorised person means the holder of the Schedule 3 authorisation and any other person stated in the authority.

146 Conditions – Schedule 8 authorisation If a condition of a Schedule 8 authorisation for a restricted Schedule 8 substance is inconsistent with a provision in Appendix D to the medicines and poisons standard, the condition prevails to the extent of the inconsistency.

147 Contravention of condition The holder of an authority must not engage in conduct that results in a contravention of a condition of the authority.

148 Duration of authority An authority remains in force for: (a) the period, not longer than 3 years, stated in it; or (b) if a longer period is prescribed by regulation – the period prescribed.

149 Form of authority An authority must: (a) be in the approved form; and (b) contain the information prescribed by regulation.

150 Notice of refusal to issue authority or impose conditions If the CHO refuses to issue an authority or issues an authority subject to stated conditions, the CHO must immediately give the applicant an information notice for the decision.

151 Failure to decide application The CHO is taken to have refused an application for an authority if the CHO does not decide the application within 30 days after: (a) the application is made; or

Medicines, Poisons and Therapeutic Goods Act 2012 88 (b) if the CHO gives the applicant notice to give the CHO further documents or information – the end of the period stated in the notice for giving the document or information.

Part 3.3 Renewal of licences and certificates of registration

152 Application for renewal (1) An application for the renewal of a certificate of registration or licence must be made by the holder of the authority. (2) Part 3.2 applies (with the necessary changes) to the application as if it were an application for an authority.

153 Authority continues until application decided If an application for the renewal of an authority is made at least 30 days before the authority ends, it continues in force until the application is decided. Part 3.4 Transfer of authorities

154 Transfer of certificate of registration (1) The holder of a certificate of registration may apply for the transfer of the certificate of registration. (2) Part 3.2 applies (with the necessary changes) to the application as if it were an application for a certificate of registration.

155 Other authorities not transferable An authority other than a certificate of registration is not transferable.

156 Definitions condition, of an authority, means a condition of the authority imposed by the CHO under section 143(2).

Division 2 Variation of conditions of authority on CHO's initiative Medicines, Poisons and Therapeutic Goods Act 2012 89 variation, of a condition of an authority, means: (a) amend an existing condition of the authority; or (b) impose a new condition of the authority; or (c) remove an existing condition of the authority. Division 2 Variation of conditions of authority on CHO's initiative

157 CHO may vary conditions to achieve object of Act (1) The CHO may decide to vary the conditions of an authority if: (a) the CHO becomes aware of information that, if it had been known when the authority was issued or renewed, the CHO would have imposed conditions or different conditions on the authority; and (b) the CHO is satisfied it is necessary to achieve the objects of this Act. (2) Before deciding to vary the conditions, the CHO must: (a) give written notice to the holder of the authority: (i) of the particulars of the proposed variation; and (ii) that the holder may make written submissions to the CHO about the proposed variation within a reasonable period of at least 21 days stated in the notice; and (b) have regard to written submissions made to the CHO by the holder before the stated day; and (c) for a Schedule 8 authorisation issued without considering the Committee's advice – consider the Committee's advice given under section 133. (3) If the CHO decides to vary the conditions of the authority, the CHO must immediately give the holder an information notice for the

Division 3 Variation of conditions of authority on application by holder Medicines, Poisons and Therapeutic Goods Act 2012 90 Division 3 Variation of conditions of authority on application by holder 158 Application (1) The holder of an authority may apply to the CHO for the variation of the conditions of the authority. (2) The application must be: (a) in the approved form; and (b) accompanied by sufficient documents and information to enable the CHO to decide the application, including the documents and information stated in the approved form.

159 CHO may require further information The CHO may, by written notice, require the applicant to give the CHO further documents or information, within the reasonable period stated in the notice, for considering and deciding the application.

160 Considering and deciding application (1) The CHO must consider the application and either vary, or refuse to vary, the conditions of the authority. (2) The CHO must refuse to vary the conditions of the authority unless satisfied the authority could be issued under Part 3.3 subject to the varied conditions.

161 Notice of decision on application (1) If the CHO decides to vary the conditions of the authority, the CHO must immediately give its holder notice of the decision. (2) If the CHO refuses to vary the conditions of the authority, the CHO must immediately give its holder an information notice for the

162 Failure to decide application The CHO is taken to have refused to vary the conditions of the authority if the CHO does not decide the application within 30 days after: (a) the application is made; or

Medicines, Poisons and Therapeutic Goods Act 2012 91 (b) if the CHO gives the applicant notice to give the CHO further documents or information – the end of the period stated in the notice for giving the document or information.

163 Application of Division This Division applies if the holder of an authority receives: (a) an information notice for the variation of conditions of the authority under section 157(3); or (b) a notice for the variation of conditions of the authority under section 161(1).

164 When variation of conditions takes effect (1) The variation of conditions of the authority takes effect on: (a) the day the notice is given to the holder of the authority; or (b) the later day of effect stated in the notice. (2) In addition, the variation of conditions does not depend on the authority being amended to record the variation or a replacement authority being issued.

165 Recording variation of conditions (1) The holder of the authority must return the authority to the CHO within 14 days after receiving the notice unless the holder has a reasonable excuse. (4) On receiving the authority, the CHO must: (a) amend the authority to give effect to the variation and return the authority to the holder; or (b) if the CHO is satisfied it is not practicable to amend the authority – issue a replacement authority incorporating the variation and send it to the holder.

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166 Grounds for suspending or cancelling authority Each of the following is a ground for suspending or cancelling an authority: (a) its holder, or an agent, contractor or employee of the holder, has contravened a provision of this Act; (b) the authority was issued, renewed or transferred because of a materially false or misleading representation; (c) the CHO becomes aware of information that, if it had been known by the CHO when the authority was issued, renewed or transferred, the CHO would have refused to issue, renew or transfer it; (d) if its holder is not a health practitioner – its holder is not, or is no longer, a suitable person to hold the authority; (e) for a certificate of registration – the nominated person for the certificate is not, or is no longer, a suitable person.

167 Show cause notice (1) If the CHO reasonably believes a ground exists to suspend or cancel an authority, the CHO must give the holder of the authority written notice under this section (a show cause notice). (2) The show cause notice must state the following: (a) the action (the proposed action) the CHO proposes taking under this Part; (b) the grounds for the proposed action; (c) an outline of the facts and circumstances forming the basis for the grounds; (d) if the proposed action is suspension of the authority – the proposed suspension period; (e) an invitation to the holder to make representations within a period stated in the notice (being at least 7 days after the date of the notice) to show cause why the proposed action should not be taken. (3) The holder of the authority may make written representations about the show cause notice to the CHO in the period stated in the notice.

Medicines, Poisons and Therapeutic Goods Act 2012 93 (4) The CHO must consider all written representations made under subsection (3) (the accepted representations). (5) If the proposed action relates to a Schedule 8 authorisation, the CHO must give the Committee all information relevant to the proposed action, including any accepted representations, for its advice.

168 Ending show cause process without further action If, after considering the accepted representations for the show cause notice and, if the proposed action relates to a Schedule 8 authorisation, the Committee's advice, the CHO no longer believes a ground exists to suspend or cancel the authority, the CHO: (a) must not take any further action about the show cause notice; and (b) must give written notice to the holder of the authority that no further action is to be taken about the show cause notice.

169 Suspension or cancellation (a) after considering the accepted representations for the show cause notice and, if the proposed action relates to a Schedule 8 authorisation, the Committee's advice, the CHO: (i) still believes a ground exists to suspend or cancel the authority; and (ii) believes suspension or cancellation of the authority is warranted; or (b) there are no accepted representations for the show cause (2) The CHO may: (a) if the proposed action stated in the show cause notice was to suspend the authority for a stated period – suspend the authority for not longer than the stated period; or (b) if the proposed action stated in the show cause notice was to cancel the authority – either cancel the authority or suspend it for a stated period. (3) The CHO must immediately give an information notice for the decision to the holder of the authority.

Medicines, Poisons and Therapeutic Goods Act 2012 94 (4) The decision takes effect on: (a) the day the information notice is given to the holder; or (b) if a later day of effect is stated in the notice – the later day.

170 Return of cancelled authority to CHO (1) If the CHO has cancelled an authority and given an information notice for the decision to the holder of the authority, the holder must return the authority to the CHO within 14 days after receiving the

171 Immediate suspension of authority pending formal cancellation procedure (1) This section applies if the CHO is satisfied: (a) a ground exists to cancel an authority; and (b) it is necessary, to protect public health and safety, to immediately suspend the authority until the cancellation procedure under sections 167 to 169 is completed. (2) The CHO must immediately suspend the authority. (3) The CHO must immediately give an information notice for the decision to the holder of the authority. (4) The suspension takes effect immediately after the information notice for the decision is given to the holder. (5) If, within 14 days after the CHO suspends the authority, the CHO gives the holder a show cause notice, the suspension lasts until the first of the following occurs: (a) the CHO cancels the suspension; (b) a decision to cancel the authority takes effect; (c) a decision is made not to cancel the authority.

Medicines, Poisons and Therapeutic Goods Act 2012 95 (6) If a show cause notice is not given to the holder within the 14-day period mentioned in subsection (5), the suspension lapses at the end of the period unless the CHO has already cancelled the suspension.

172 Medical examination for some authorities (1) This section applies to the following persons: (a) an applicant for a Schedule 7 authorisation or pest management technician licence; (b) the holder of: (i) a Schedule 7 authorisation; or (ii) a pest management technician licence; (c) an employee of a person mentioned in paragraph (b). (2) The CHO may, by written notice given to the person, require the person, within the reasonable time stated in the notice, to: (a) undergo a medical examination; and (b) give the CHO the results of the examination. (3) The person must comply with the notice. (4) If the CHO is satisfied the results of the medical examination indicate the use or continued use of Schedule 7 substances or pesticides by the person is a threat to the person's health, the CHO may: (a) for a person mentioned in subsection (1)(a) – under section 134(4), refuse to issue the authority; or (b) for a person mentioned in subsection (1)(b)(i): (i) under Part 3.5, vary the conditions of the person's authority; or (ii) under Part 3.6, suspend for a stated period or cancel, the person's authority; or

Medicines, Poisons and Therapeutic Goods Act 2012 96 (c) for a person mentioned in subsection (1)(b)(ii): (i) under Part 3.3, refuse to renew the person's authority; or (ii) under Part 3.5, vary the conditions of the person's authority; or (iii) under Part 3.6, suspend for a stated period or cancel, the person's authority; or (d) for an employee mentioned in subsection (1)(c) – by written notice given to the employee's employer, order the employer to cease employing the employee in any capacity involving the handling of, or exposure to, the Schedule 7 substances or pesticides stated in the order. (5) The CHO must give the employer and employee an information notice for the decision to give the notice under subsection (4)(d). (6) The employer must comply with the notice. (7) An offence against subsection (3) or (6) is an offence of strict (8) It is a defence to a prosecution for an offence against subsection (3) or (6) if the defendant establishes a reasonable

173 Authority holder to give notice of change of particulars (1) The holder of an authority commits an offence if: (a) there is a change in a particular contained in the authority; and (b) the particular is prescribed by regulation; and (c) the holder does not give written notice to the CHO about the change within 14 days after the change.

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174 Replacement of authority (1) The CHO may issue a replacement authority to the holder of an authority if satisfied the original authority has been lost, stolen or destroyed. (2) For subsection (1), the CHO may require the holder or, if the authority is a certificate of registration, the nominated person for the authority, to give the CHO a statutory declaration stating the original authority has been lost, stolen or destroyed.

175 Surrender of authority (1) The holder of an authority may surrender the authority by written notice given to the CHO. (2) The surrender takes effect on: (a) the day the notice is given to the CHO; or (b) if a later day of effect is stated in the notice – the later day. (3) The person who held the authority must return it to the CHO within 14 days after the day the surrender takes effect. (4) An offence against subsection (3) is an offence of strict liability.

176 Display of certificate of registration (1) The holder of a certificate of registration must display the certificate in a prominent place at the registered place. (2) A retailer licensee must display the licence in a prominent place at the licensed place. (3) An offence against subsection (1) or (2) is an offence of strict subsection (1) or (2) if the defendant establishes a reasonable

Medicines, Poisons and Therapeutic Goods Act 2012 98 (5) In addition, if the holder of the certificate of registration or licence gives it to the CHO when required by the CHO, the holder does not commit an offence against subsection (1) or (2) while the holder does not have the authority.

177 Authority not personal property For section 8(1)(k) of the Personal Property Securities Act 2009 (Cth), an authority is not personal property for that Act. Note for section 177 A law of the Commonwealth, a State or a Territory may declare a right, licence or authority granted by or under that law not to be personal property for the Personal Property Securities Act 2009 (Cth).

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Part 4.1 Interpretation

178 Definitions In this Chapter: at, in relation to a place, includes on and in the place. connected, see section 179. enter, a place, includes re-enter and board the place. occupier, of a place, includes a person who reasonably appears to be an occupier of the place.

179 When thing is connected with offence For this Chapter, a thing is connected with an offence if: (a) the offence has been committed in relation to the thing; or (b) the thing will afford evidence of the commission of the offence; or (c) the thing was used, is being used or is intended to be used, for the purpose of committing the offence.

180 Entry of place – general (1) For the administration or enforcement of this Act, an authorised officer may enter: (a) a place (other than a dwelling) at any reasonable time; or (b) any place at any time: (i) with the consent of the occupier of the place; or (ii) under a search warrant issued under this Part for the place.

Medicines, Poisons and Therapeutic Goods Act 2012 100 (2) An authorised officer (other than a police officer in uniform) who enters a place under subsection (1) must not remain at the place if, when asked by the occupier of the place, the officer does not produce for the occupier's inspection:

181 Consent to entry (1) An authorised officer (other than a police officer in uniform) seeking the consent of an occupier of a place to enter the place must produce to the occupier for inspection: (2) In addition, an authorised officer seeking the consent of an occupier of a place to enter the place must: (a) give the occupier the reasons why entry is sought; and (b) inform the occupier that the occupier may refuse to give consent. (3) If: (a) it is material in proceedings for a court to be satisfied the occupier consented to entry under this Part; and (b) written consent of the occupier is not produced in evidence; the court may presume, in the absence of evidence to the contrary, the occupier did not give consent.

182 Entry of place – search warrant (1) An authorised officer may apply to a justice of the peace, by information on oath, for a search warrant for a place if the officer reasonably believes an offence against this Act is about to be, is being or has been committed at the place. (2) The justice of the peace may issue a search warrant only if satisfied about the matters set out in the information.

Medicines, Poisons and Therapeutic Goods Act 2012 101 (3) The warrant authorises the officer named in the warrant, and any other person helping the officer, to enter the place and to exercise an authorised officer's powers under this Part. (4) The warrant must state: (a) the purpose for which it is issued; and (b) the nature of the offence or contravention for which the entry is authorised; and (c) the hours during which entry to the place is authorised or state that the entry is authorised at any time of the day or night; and (d) the date, within 30 days after the warrant's issue, the warrant ceases to have effect. (5) The authorised officer executing the warrant must, if asked by the occupier of the place or another person at the place, produce the warrant for the person's inspection.

183 Entry to Aboriginal land (1) An authorised officer's powers in relation to a place under this Part include powers in relation to Aboriginal land even though the officer does not hold a permit to enter Aboriginal land under the Aboriginal Land Act 1978. Aboriginal land, see section 3(1) of the Aboriginal Land Rights (Northern Territory) Act 1976 (Cth).

184 Additional powers for entry of aircraft, vehicle or vessel (1) This section applies if an authorised officer has reasonable grounds for suspecting: (a) an aircraft, vehicle or vessel is being, has been or is likely to be, used in the commission of an offence against this Act; or (b) an aircraft, vehicle or vessel, or a thing in or on an aircraft, vehicle or vessel, may provide evidence of the commission of an offence against this Act. (2) For entering the aircraft, vehicle or vessel under this Part, the authorised officer may require the person in control of the aircraft, vehicle or vessel: (a) to stop, move or not to move it; or

Part 4.3 Powers of authorised officers on entry of places Medicines, Poisons and Therapeutic Goods Act 2012 102 (b) to bring it to a stated place and remain in control of it until the officer permits it to depart; or (c) to give the officer reasonable help. (3) A person commits an offence if the person engages in conduct that results in a contravention of the authorised officer's requirement. Part 4.3 Powers of authorised officers on entry of

185 Powers on entry of place (1) An authorised officer who enters a place under Part 4.2 may do any of the following: (a) inspect or examine the place or anything found at the place; (b) break open and search fixtures and fittings, furniture and furnishings or boxes, packages and other containers found at the place; (c) take measurements of, or conduct tests in relation to, the place or anything found at the place; (d) take photographs, films or audio, video or other recordings of the place or anything found at the place; (e) take and remove from the place samples for analysis of anything found at the place; (f) take copies of, or extracts from, documents found at the place; (g) require a person at the place to: (i) answer questions or provide information; or (ii) make available documents kept at the place; or (iii) give the officer reasonable help to exercise powers under this section; (h) subject to section 186: (i) seize anything found at the place; or

Part 4.3 Powers of authorised officers on entry of places Medicines, Poisons and Therapeutic Goods Act 2012 103 (ii) if the place is an aircraft, vehicle or vessel – seize it. (2) After taking a sample under subsection (1)(e) or seizing a thing under subsection (1)(h), the authorised officer must give a receipt for the sample or thing to: (a) the occupier of the place; or (b) the person whom the authorised officer reasonably believes had possession or control of the sample or thing immediately before it was taken or seized. (3) A requirement under subsection (1)(g) must be given by written (4) When making the requirement, the authorised officer must inform the person it is an offence not to comply with the requirement unless the person establishes a reasonable excuse. (5) The person must comply with the requirement. subsection (5) if the defendant establishes a reasonable excuse. (7) Without limiting subsection (6), it is a reasonable excuse for an individual to fail to answer a question under subsection (1)(g)(i) if complying with the requirement might tend to incriminate the individual.

186 Restriction on power of seizure An authorised officer may seize a thing under section 185(1)(h) only if the officer reasonably believes the thing: (a) is connected with an offence against this Act and the seizure is necessary to prevent the thing from being: (i) concealed, lost, damaged or destroyed; or (ii) used to commit the offence; or (b) is connected with an offence against this Act and the seizure is necessary to conduct tests for adducing evidence for a prosecution for the offence.

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187 Authorised officer may use help and force in exercising powers An authorised officer may exercise a power under this Part with the help, and using the force, that is reasonable in the circumstances.

188 Application of Division This Division applies if, under Part 4.3, an authorised officer seizes a thing (the seized thing).

189 Notice of seizure of thing (1) As soon as practicable after seizing the thing, the authorised officer must give written notice of the seizure to the person from whom it is seized. (2) The notice must include the following details: (a) a description of the thing; (b) the reason for seizing the thing; (c) details of the right under section 192 to apply to the Local Court for an order disallowing the seizure; (d) if the thing has been removed from the place where it was seized – the address of the place where the thing is held.

190 Retention of thing seized (1) An authorised officer may, until the start of a proceeding for an offence against this Act in relation to the seized thing and (if necessary) during the proceeding: (a) keep the thing at the place where it was found; or (b) remove the thing to another place and keep it there in the officer's possession or under the officer's control. (2) If the thing is kept under subsection (1)(a), an authorised officer: (a) must ensure the thing is identified in a way that indicates it has been seized under this Act; and

Medicines, Poisons and Therapeutic Goods Act 2012 105 (b) may physically segregate the thing. Examples for subsection (2) 1 The seized thing could be placed in an appropriately labelled container. 2 A barrier with appropriate signs could be placed around the seized thing. (3) A person commits an offence if the person: (a) interferes with or disposes of the seized thing; or (b) removes the seized thing from: (i) the place it was seized; or (ii) the place to which it was removed by an authorised officer. (4) Subsection (3) does not apply if the person has the written consent of the CHO.

191 Return of seized thing If, before the seized thing is forfeited to the Territory under section 197, the CHO becomes satisfied no offence relating to the thing has been committed against this Act, the CHO must, as soon as practicable, deliver the thing to the person who appears to the CHO to be entitled to it.

192 Application for order disallowing seizure A person may apply to the Local Court for an order disallowing the seizure of a seized thing within 3 days after it is seized.

193 CHO is respondent to application The CHO is the respondent to the application. Note for section 193 Under the Local Court (Civil Jurisdiction) Rules 1998, the applicant must serve a copy of the application on the CHO.

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194 Order disallowing seizure (1) On hearing the application, the Local Court must make an order disallowing the seizure of the seized thing if the Court is satisfied: (a) it is: (i) proved the applicant would be entitled to the thing if it had not been seized; and (ii) not proved an offence relating to the thing has been committed against this Act; or (b) there are exceptional circumstances justifying the making of the order. (2) Otherwise, the Court must dismiss the application.

195 Ancillary orders (1) If the Local Court makes an order disallowing the seizure of the seized thing, the Court must also make one or both of the following orders: (a) an order directing the CHO to deliver the seized thing to the applicant; (b) if the thing cannot for any reason be delivered or has, as a consequence of being seized, depreciated in value – an order directing the CHO to pay to the applicant the amount of compensation the Court considers just. (2) The Court may make the orders as to costs as it considers just.

196 Adjournment pending hearing of other proceeding (1) The Local Court may adjourn the hearing of the application if it appears to the Court the seized thing is required to be produced in evidence in a proceeding (which may be pending) in connection with an offence against this Act or another law of the Territory. (2) The adjournment may be made on the application of the CHO or on the Court's initiative. (3) The adjournment may be until the proceeding in connection with the offence is decided.

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