Medicines, Poisons and Therapeutic Goods Act 2022 (NSW)

Case
No judgment structure available for this case.

See also—

Public Health (Tobacco) Amendment (Illicit Tobacco) Bill 2025 [Non-government Bill— Ms K A Sloane, MP]

Note—

Amending provisions are subject to automatic repeal pursuant to sec 30C of the Interpretation Act 1987 No 15 once the amendments have taken effect.

An Act to regulate activities involving scheduled substances and certain therapeutic goods to protect public health and safety; to repeal the Poisons and Therapeutic Goods Act 1966 and certain instruments under that Act; and to make consequential amendments to other legislation.

Chapter 1Preliminary1Name of Act

This Act is the Medicines, Poisons and Therapeutic Goods Act 2022.

2Commencement

This Act commences on a day or days to be appointed by proclamation.

3Objects of Act(1)

The objects of this Act are as follows—

  • (a)

    to regulate activities involving scheduled substances and other prescribed therapeutic goods to protect public health and safety,

  • (b)

    to use the Commonwealth Poisons Standard as the basis for classifying and regulating certain substances,

  • (c)

    to complement the Commonwealth laws that regulate therapeutic goods, including by providing for certain Commonwealth laws to apply as a law of New South Wales in relation to the activities of persons who are not corporations,

  • (d)

    to authorise certain activities involving scheduled substances and other prescribed therapeutic goods, including when the activities are prohibited under another law,

  • (e)

    to provide for effective administration and enforcement mechanisms in relation to scheduled substances and other prescribed therapeutic goods.

(2)

In the exercise of functions under this Act, the protection of public health and safety must be the paramount consideration.

4Definitions(1)

The Dictionary in Schedule 3 defines words used in this Act.

Note—

The Interpretation Act 1987 contains definitions and other provisions affecting the interpretation and application of this Act.

(2)

A reference in this Act to a substance using “Schedule” with a number is a reference to the substance specified in the Schedule with that number in the NSW Poisons Schedules.

Example—

A Schedule 7 substance means a substance specified in Schedule 7 of the NSW Poisons Schedules.

5Meaning of “supply” and “wholesale supply”(1)

In this Act, to supply scheduled substances and other prescribed therapeutic goods includes the following—

  • (a)

    to sell, dispense and distribute,

  • (b)

    to supply, whether for free or otherwise, as a sample or advertisement,

  • (c)

    to supply, whether for free or otherwise, for testing for safety or efficacy on humans or animals,

  • (d)

    to agree or offer to sell or distribute,

  • (e)

    to keep or possess for sale, dispensing or distribution,

  • (f)

    to send, forward, deliver or receive for sale, dispensing or distribution,

  • (g)

    to authorise, direct, cause or allow one or more of the above to be done.

(2)

In this Act, to supply scheduled substances and other prescribed therapeutic goods does not include the following—

  • (a)

    to administer scheduled substances or other prescribed therapeutic goods,

  • (b)

    to supply scheduled substances or other prescribed therapeutic goods to a worker by a person for whom the worker works if—

    • (i)

      the person is authorised to obtain the substance or goods, and

    • (ii)

      the worker is authorised to supply, administer or use the substance or goods in connection with the worker’s work,

  • (c)

    to supply scheduled substances or other prescribed therapeutic goods by an authorised practitioner to another authorised practitioner in the same practice for the purposes of supply or administration to patients of the practice,

  • (d)

    to supply in other prescribed circumstances, whether generally or in relation to prescribed scheduled substances or other prescribed therapeutic goods.

(3)

In this Act, to wholesale supply scheduled substances and other prescribed therapeutic goods means to supply the substance or goods for the purposes of resupply.

(4)

In this Act, to wholesale supply scheduled substances and other prescribed therapeutic goods does not include the following—

  • (a)

    to wholesale supply scheduled substances or other prescribed therapeutic goods to a worker by a person for whom the worker works if—

    • (i)

      the person is authorised to obtain the substance or goods, and

    • (ii)

      the worker is authorised to supply, administer or use the substance or goods in connection with the worker’s work,

  • (b)

    to wholesale supply scheduled substances or other prescribed therapeutic goods by an authorised practitioner to another authorised practitioner in the same practice for the purposes of supply or administration to patients of the practice,

  • (c)

    to wholesale supply scheduled substances or other prescribed therapeutic goods by an authorised practitioner or pharmacist to an agent or carer of a patient or animal for the purposes of supply or administration to the patient or animal,

  • (d)

    to wholesale supply in other prescribed circumstances, generally or in relation to prescribed scheduled substances or other prescribed therapeutic goods.

(5)

In this section—

worker means a person who does work for another person, whether as an employee, contractor or volunteer.

6Meaning of “NSW Poisons Schedules”(1)

The Schedules to the Commonwealth Poisons Standard, as modified by the regulations—

  • (a)

    apply for the purposes of this Act, and

  • (b)

    are referred to in this Act as the NSW Poisons Schedules.

(2)

For the purposes of determining the Schedule to which a substance belongs, or the meaning of a reference to a scheduled substance in this Act, the following provisions of the Commonwealth Poisons Standard apply, as modified by the regulations—

  • (a)

    the definitions,

  • (b)

    other interpretation provisions,

  • (c)

    the Appendices.

(3)

The regulations may modify the application of provisions of the Commonwealth Poisons Standard for the purposes of this Act, including by doing the following—

  • (a)

    adding a substance to or omitting a substance from—

    • (i)

      a Schedule, or

    • (ii)

      an Appendix, or

    • (iii)

      a class or subclass of substances,

  • (b)

    excluding the following from the NSW Poisons Schedule—

    • (i)

      a Schedule or part of a Schedule,

    • (ii)

      an Appendix or part of an Appendix,

    • (iii)

      a class or subclass of substances or part of a class or subclass of substances,

  • (c)

    relocating a substance from a Schedule or Appendix to another Schedule or Appendix,

  • (d)

    relocating a substance from a class or subclass of substances to another class or subclass, whether for the purposes of the same Schedule or Appendix or another Schedule or Appendix,

  • (e)

    renaming a Schedule, Appendix or class or subclass of substances,

  • (f)

    adding a Schedule, Appendix or class or subclass of substances,

  • (g)

    creating a category of substances for a Schedule or Appendix,

  • (h)

    modifying the interpretative provisions specified in subsection (2).

(4)

To avoid doubt, the modifications that may be made by the regulations are not limited by the way in which the Commonwealth Poisons Standard does, or does not, classify or otherwise organise substances or classes or subclasses of substances.

(5)

Without limiting subsections (3) and (4) or the Interpretation Act 1987, section 42, a modification may be limited in its application to—

  • (a)

    specified provisions of this Act or the regulations, or

  • (b)

    specified purposes or circumstances.

7Effect of classification of substances(1)

This Act does not prevent a substance from being classified or subclassified as a scheduled substance and as a therapeutic good at the same time.

(2)

If a substance is classified or subclassified as a scheduled substance or in a subclass of a scheduled substance, by reference to persons prevented, authorised or permitted to do activities involving the substance, the substance’s classification or subclassification continues to apply for this Act in relation to activities carried out by other persons.

Chapter 2Regulation of supply, prescriptions and other activitiesPart 2.1Introduction8Application of Chapter(1)

This Chapter makes it an offence to carry out the following activities unless authorised under this Act—

  • (a)

    wholesale supply of scheduled substances and other prescribed therapeutic goods—see Part 2.2,

  • (b)

    obtaining wholesale supply of scheduled substances and other prescribed therapeutic goods—see Part 2.3,

  • (c)

    non-wholesale supply of scheduled substances and other prescribed therapeutic goods—see Part 2.4,

  • (d)

    the issue of prescriptions for scheduled substances and other prescribed therapeutic goods—see Part 2.5.

(2)

This Chapter does not limit the circumstances in which an activity that is prohibited under this Chapter may be authorised under another provision of this Act.

Note—

Activities may also be authorised under the regulations or Chapter 3.

9Authorisation of activities under other laws(1)

An activity referred to in Parts 2.2–2.6 is authorised for the purposes of this Act if the activity is carried out in accordance with a right, entitlement or authority conferred by a relevant law.

Example—

The Pesticides Act 1999 authorises the possession and use of certain Schedule 7 substances.

(2)

The regulations may prescribe limitations or restrictions on the carrying out of activities authorised under subsection (1).

(3)

To avoid doubt, it is not an offence under this Chapter to carry out an activity authorised under subsection (1).

10Authorisation of activities by regulations(1)

The regulations may provide for the following in relation to activities—

  • (a)

    the persons or classes of persons who are authorised to carry out activities for the purposes of this Act,

  • (b)

    the circumstances in which activities are authorised for the purposes of this Act,

  • (c)

    the conditions, limitations, restrictions or other requirements for the carrying out of activities authorised for the purposes of this Act,

  • (d)

    exemptions from prescribed conditions, limitations, restrictions or other requirements.

(2)

The regulations may provide for the Health Secretary to do the following, for the purposes of this Act, in relation to activities—

  • (a)

    authorise persons or classes of persons to carry out the activities,

  • (b)

    determine the circumstances in which activities are authorised,

  • (c)

    determine the conditions, limitations, restrictions or other requirements for the carrying out of authorised activities,

  • (d)

    exempt persons or classes of persons from prescribed conditions, limitations, restrictions or other requirements.

(3)

Without limiting subsection (1) or (2), the regulations may provide for—

  • (a)

    the Health Secretary to issue licences to authorise the retail sale of prescribed Schedule 2 and 7 substances, and

  • (b)

    other matters relating to the licences, including applications for licences, determination of applications, licence conditions and licence fees.

(4)

The regulations must not provide for the Health Secretary to authorise a person to issue prescriptions for scheduled substances and other therapeutic goods.

(5)

Regulations may be made under this section in relation to an activity despite other provisions of this Act that regulate the activity.

11Regulations about application of Parts 2.2–2.6(1)

The regulations may—

  • (a)

    exclude scheduled substances or other therapeutic goods from the operation of Parts 2.2–2.6, and

  • (b)

    apply Parts 2.2–2.6 to other scheduled substances or therapeutic goods.

(2)

The regulations may exclude all or some substances in a NSW Poisons Schedule from the operation of Parts 2.2–2.6.

(3)

A reference in a provision in Parts 2.2–2.6 to scheduled substances or other prescribed therapeutic goods is a reference to the scheduled substances and other prescribed therapeutic goods to which the provision applies.

(4)

The regulations may prescribe a penalty, not exceeding a Tier 1 penalty, for the purposes of—

  • (a)

    paragraph (e) of the penalty provision in sections 14 and 28, and

  • (b)

    paragraph (d) of the penalty provision in section 36.

12Regulations may prohibit or restrict authorised activities(1)

Despite any other provision of this Act, the regulations may—

  • (a)

    prohibit a person, or a class of persons, from carrying out an activity, or

  • (b)

    impose conditions, limitations, restrictions or other requirements on a person, or a class of persons, carrying out an activity.

(2)

This section applies in relation to the carrying out of an activity by a person, or a class of persons, even if the person, or class of persons, is otherwise authorised to carry out the activity under this Act.

Part 2.2Wholesale supply13Application of Part(1)

This Part applies to Schedule 2, 3, 4, 7, 8, 9 and 10 substances, subject to the regulations.

(2)

This Part also applies to other prescribed therapeutic goods.

Note—

Regulations under section 11 may—

  • (a)

    exclude scheduled substances or other therapeutic goods from the operation of this Part, and

  • (b)

    apply this Part to other scheduled substances or therapeutic goods.

14Offence—unauthorised wholesale supply

A person must not wholesale supply, or cause or permit wholesale supply of, scheduled substances or other prescribed therapeutic goods unless—

  • (a)

    the wholesale supply is authorised under this Act, and

  • (b)

    the person receiving the substance or goods is authorised to obtain the substance or goods under Part 2.3.

Maximum penalty—

  • (a)

    for a Schedule 10 substance—Tier 1 penalty, or

  • (b)

    for a Schedule 7 substance—Tier 2 penalty, or

  • (c)

    for a Schedule 2 or 3 substance—Tier 3 penalty, or

  • (d)

    for a Schedule 4 substance other than a Schedule 4D substance—Tier 3 penalty, or

  • (e)

    otherwise—the prescribed penalty.

Note—

The Drug Misuse and Trafficking Act 1985 also prohibits the supply of prohibited drugs and prohibited scheduled substances. There is an exception for supply authorised under this Act.

15Wholesale supply by licensed wholesalers(1)

Wholesale supply of scheduled substances and other prescribed therapeutic goods is authorised if the substance or goods are wholesale supplied by the holder of a wholesaler licence that authorises the holder to wholesale supply the substance or goods.

(2)

This section does not apply to a Schedule 7 substance.

16Wholesale supply of Schedule 7 substances(1)

Wholesale supply of Schedule 7 substances, other than prescribed Schedule 7 substances, is authorised if the wholesale supply is for—

  • (a)

    non-domestic use, or

  • (b)

    resupply to a person who is authorised to possess or use the substance under the Pesticides Act 1999.

(2)

Wholesale supply of prescribed Schedule 7 substances is authorised if the substance is—

  • (a)

    supplied by the holder of a wholesaler licence that authorises the holder to wholesale supply the substance, or

  • (b)

    resupplied to a person who is authorised to possess or use the substance under the Pesticides Act 1999.

17Wholesale supply by public health entities(1)

Wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by a public health entity to another public health entity is authorised.

(2)

Wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods for the purposes of the State Vaccine Centre by the Health Secretary, or a person operating the State Vaccine Centre on the Health Secretary’s behalf, is authorised.

18Wholesale supply between pharmacists

Wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by a pharmacist from a pharmacy (the supplying pharmacist) to another pharmacist for a pharmacy (the receiving pharmacist) is authorised if—

  • (a)

    the supplying pharmacist receives a written request in the approved form signed by the receiving pharmacist in the following circumstances—

    • (i)

      the receiving pharmacist is making the request to satisfy an order of a single customer,

    • (ii)

      the supplying pharmacist, as far as reasonably practicable, supplies the receiving pharmacist only the minimum amount of the substance or goods necessary to satisfy the order of the customer, or

  • (b)

    the supplying pharmacist is returning an equivalent amount of the substance or goods to a pharmacist who had previously supplied the same substance or goods in accordance with paragraph (a)(ii).

s 18: Am 2023 No 35, Sch 1.14.

19Return of wholesale supply

Wholesale supply of scheduled substances and other prescribed therapeutic goods is authorised if—

  • (a)

    the substance or goods were obtained by wholesale supply that is authorised under this Act, and

  • (b)

    the substance or goods are being returned to the holder of a wholesaler licence that authorises the holder to wholesale supply the substance or goods.

Part 2.3Obtaining wholesale supplyNote—

The Drug Misuse and Trafficking Act 1985 also prohibits the possession of prohibited drugs and prohibited scheduled substances. There is an exception for possession authorised under this Act.

20Application of Part(1)

This Part applies to Schedule 2, 3, 4, 7, 8, 9 and 10 substances, subject to the regulations.

(2)

This Part also applies to other prescribed therapeutic goods.

Note—

Regulations under section 11 may—

  • (a)

    exclude scheduled substances or other therapeutic goods from the operation of this Part, and

  • (b)

    apply this Part to other scheduled substances or therapeutic goods.

21Obtaining wholesale supply by health practitioners and others(1)

Obtaining wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by the following is authorised—

  • (a)

    a medical practitioner for medical treatment of a person,

  • (b)

    a nurse practitioner for treatment of a person,

  • (c)

    a dentist for dental treatment of a person,

  • (d)

    a veterinary practitioner for treatment of an animal,

  • (e)

    a nurse, midwife, podiatrist or optometrist if—

    • (i)

      the person’s registration has an endorsement of a kind specified in the Health Practitioner Regulation National Law, section 94 that the person is qualified to possess, use or supply the substance or goods, and

    • (ii)

      the substance or goods are obtained for a purpose for which the person is qualified,

  • (f)

    a pharmacist for a pharmacy,

  • (g)

    a prescribed health practitioner for treatment of a person,

  • (h)

    a private health facility,

  • (i)

    the holder of a licence under the Commonwealth Therapeutic Goods Act, Part 3-3 or the Commonwealth Agvet Codes, Part 8.

(2)

Subsection (1)(h) does not apply in relation to a Schedule 8 substance if the private health facility’s licence under the Private Health Facilities Act 2007 prohibits the supply of a Schedule 8 substance.

22Obtaining wholesale supply by public health entities

Obtaining wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by the following is authorised—

  • (a)

    a public hospital controlled by the Crown,

  • (b)

    a recognised establishment, within the meaning of the Health Services Act 1997, of an affiliated health organisation that is a hospital,

  • (c)

    a local health district,

  • (d)

    a prescribed statutory health corporation,

  • (e)

    the Health Secretary, or a person operating the State Vaccine Centre on the Health Secretary’s behalf, for the purposes of the State Vaccine Centre,

  • (f)

    the Health Administration Corporation,

  • (g)

    another prescribed entity.

23Obtaining wholesale supply in residential aged care facilities(1)

Obtaining wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by an authorised person for a residential care facility for use in connection with the treatment of residents in the facility is authorised.

(2)

In this section—

authorised person, for a residential care facility, means—

  • (a)

    the director of nursing for the facility, or

  • (b)

    if there is no director of nursing for the facility—a manager of the facility nominated by the approved provider, within the meaning of the Aged Care Act 1997 of the Commonwealth, in relation to the facility, or

  • (c)

    another prescribed person or a person of a prescribed class.

24Obtaining wholesale supply in correctional centres and detention centres(1)

Obtaining wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods by the following is authorised—

  • (a)

    an authorised person for a managed correctional centre for use in connection with the treatment of inmates in the centre,

  • (b)

    an authorised person for a detention centre for use in connection with the treatment of detainees in the centre,

  • (c)

    an authorised person for an immigration detention centre for use in connection with the treatment of detainees in the centre.

Note—

Subsection (1) does not limit the authority of an authorised person to obtain wholesale supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods under another provision of this Division that authorises the person to obtain the substances or therapeutic goods.

(2)

In this section—

authorised person means—

  • (a)

    for a managed correctional centre—

    • (i)

      a pharmacist employed or engaged by the management company for the managed correctional centre to receive wholesale supply of scheduled substances and prescribed therapeutic goods on behalf of the company, or

    • (ii)

      if there is no pharmacist as specified in subparagraph (i)—an authorised practitioner, or a registered nurse in charge of the medical treatment of inmates at the centre, appointed by the management company to receive the supply, and

  • (b)

    for a detention centre—a medical officer appointed for the detention centre, and

  • (c)

    for an immigration detention centre—

    • (i)

      a pharmacist employed or engaged by the centre to receive wholesale supply of scheduled substances and prescribed therapeutic goods on behalf of the centre, or

    • (ii)

      if there is no pharmacist as specified in subparagraph (i)—an authorised practitioner, or a registered nurse in charge of the medical treatment of detainees at the centre, appointed by the centre to receive the supply.

25Obtaining wholesale supply by licence holders

Obtaining wholesale supply of Schedule 2, 3, 4, 8, 9 and 10 substances and other prescribed therapeutic goods is authorised if the substance or goods are obtained by—

  • (a)

    the holder of an obtain licence that authorises the holder to obtain the substance or goods, or

  • (b)

    the holder of a wholesaler licence that authorises the holder to wholesale supply the substance or goods.

26Obtaining wholesale supply of Schedule 7 substances(1)

Obtaining wholesale supply of Schedule 7 substances, other than prescribed Schedule 7 substances, is authorised if the substance is obtained for—

  • (a)

    non-domestic use, or

  • (b)

    resupply to a person who is authorised to possess or use the Schedule 7 substance under the Pesticides Act 1999.

(2)

Obtaining wholesale supply of prescribed Schedule 7 substances is authorised if the substance is obtained—

  • (a)

    by the holder of an obtain licence that authorises the holder to obtain the substance, or

  • (b)

    by the holder of a wholesaler licence that authorises the holder to wholesale supply the substance, or

  • (c)

    for resupply to a person authorised to possess or use the substance under the Pesticides Act 1999.

(3)

Obtaining wholesale supply of a Schedule 7 substance is authorised if the person obtaining the substance is authorised to possess or use the substance under the Pesticides Act 1999.

Part 2.4Non-wholesale supply27Application of Part(1)

This Part applies to Schedule 2, 3, 4, 7, 8, 9 and 10 substances, subject to the regulations.

(2)

This Part also applies to other prescribed therapeutic goods.

(3)

This Part does not apply in relation to wholesale supply.

Note—

Regulations under section 11 may—

  • (a)

    exclude scheduled substances or other therapeutic goods from the operation of this Part, and

  • (b)

    apply this Part to other scheduled substances or therapeutic goods.

28Offence—unauthorised non-wholesale supply(1)

A person must not supply, or cause or permit the supply of, scheduled substances or other prescribed therapeutic goods unless the supply is authorised under this Act.

Maximum penalty—

  • (a)

    for a Schedule 10 substance—Tier 2 penalty, or

  • (b)

    for a Schedule 7 substance—Tier 3 penalty, or

  • (c)

    for a Schedule 2 or 3 substance—Tier 4 penalty, or

  • (d)

    for a Schedule 4 substance other than a Schedule 4D substance—Tier 4 penalty, or

  • (e)

    otherwise—the prescribed penalty.

(2)

It is not an offence under this section to supply, or cause or permit the supply of, a Schedule 7 substance to a person if the person is authorised to possess or use the Schedule 7 substance under the Pesticides Act 1999.

Note—

The Drug Misuse and Trafficking Act 1985 also prohibits the supply of prohibited drugs and prohibited scheduled substances. There is an exception for supply authorised under this Act.

29Non-wholesale supply by health practitioners and veterinary practitioners

The supply of Schedule 2, 3, 4 and 8 substances and other prescribed therapeutic goods is authorised if the supply is by the following—

  • (a)

    a medical practitioner for medical treatment of a person,

  • (b)

    a nurse practitioner for treatment of a person,

  • (c)

    a dentist for dental treatment of a person,

  • (d)

    a veterinary practitioner for treatment of an animal,

  • (e)

    a nurse, midwife, podiatrist or optometrist if—

    • (i)

      the person’s registration has an endorsement of a kind specified in the Health Practitioner Regulation National Law, section 94 that the person is qualified to possess, use, supply or prescribe the substance or goods, and

    • (ii)

      the substance or goods are obtained for a purpose for which the person is qualified,

  • (f)

    a prescribed health practitioner for treatment of a person.

30Non-wholesale supply by pharmacists in pharmacies(1)

The supply of Schedule 2 and 3 substances and other prescribed therapeutic goods is authorised if the supply is by a pharmacist in a pharmacy.

(2)

The supply of Schedule 2 substances is authorised if the supply is by a person employed or engaged by a pharmacy to a customer of the pharmacy.

(3)

The supply of Schedule 4 and 8 substances and other prescribed therapeutic goods is authorised if the supply is—

  • (a)

    by a pharmacist in a pharmacy, and

  • (b)

    on a prescription that was authorised to be issued under section 37.

31Non-wholesale supply by pharmacists in hospitals(1)

The supply of Schedule 2 and 3 substances and other prescribed therapeutic goods is authorised if the supply is by a pharmacist in—

  • (a)

    a public health entity, or

  • (b)

    a private health facility.

(2)

The supply of Schedule 4 and 8 substances and other prescribed therapeutic goods is authorised if the supply is—

  • (a)

    by a pharmacist in—

    • (i)

      a public health entity, or

    • (ii)

      a private health facility, and

  • (b)

    on one of the following—

    • (i)

      a prescription that was authorised to be issued under section 37,

    • (ii)

      the written authorisation of an authorised practitioner, if the authorisation is entered on the patient’s medication chart,

    • (iii)

      the written requisition of an appropriate person.

(3)

In this section—

appropriate person means—

  • (a)

    an authorised practitioner, or

  • (b)

    a registered nurse or midwife in charge of the ward in which the substance is supplied.

authorised practitioner does not include a veterinary practitioner.

32Non-wholesale supply by pharmacists in managed correctional centres(1)

The supply of Schedule 2, 3, 4 or 8 substances and other prescribed therapeutic goods is authorised if the supply is by a pharmacist employed or engaged by a managed correctional centre for the purposes of treating an inmate at the managed correctional centre.

(2)

The supply of Schedule 4 or 8 substances and other prescribed therapeutic goods is authorised under subsection (1) only if the supply is—

  • (a)

    on the written authorisation of an authorised practitioner, if the authorisation is entered on the inmate’s medication chart, or

  • (b)

    on the written requisition of an appropriate person.

(3)

This section does not affect the supply of a scheduled substance or other prescribed therapeutic goods by a pharmacist employed or engaged by a pharmacy located at a managed correctional centre if the supply is otherwise authorised under this Act.

(4)

In this section—

appropriate person means an authorised practitioner, registered nurse or midwife appointed, by written instrument, by the management company for the managed correctional centre for the purposes of this section.

authorised practitioner does not include a veterinary practitioner.

33Non-wholesale supply by carers

The supply of Schedule 2, 3, 4 or 8 substances and other prescribed therapeutic goods by a carer of a person to the person is authorised if the substance or goods have been lawfully supplied to the carer for supply to the person for the person’s therapeutic treatment.

34Non-wholesale supply by State Vaccine Centre

The supply of scheduled substances and other prescribed therapeutic goods for the purposes of the State Vaccine Centre by the Health Secretary, or a person operating the State Vaccine Centre on the Health Secretary’s behalf, is authorised.

Part 2.5Prescriptions35Application of Part(1)

This Part applies to Schedule 2, 3, 4, 7, 8, 9 and 10 substances, subject to the regulations.

(2)

This Part also applies to other prescribed therapeutic goods.

Note—

Regulations under section 11 may—

  • (a)

    exclude scheduled substances or other therapeutic goods from the operation of this Part, and

  • (b)

    apply this Part to other scheduled substances or therapeutic goods.

36Offence—unauthorised issue of prescription

A person must not issue a prescription for a Schedule 2, 3, 4, 7, 8, 9 or 10 substance unless the issue of the prescription is authorised under this Act.

Maximum penalty—

  • (a)

    for a Schedule 8, 9 or 10 substance—Tier 2 penalty, or

  • (b)

    for a Schedule 4D or 7 substance—Tier 3 penalty, or

  • (c)

    for a Schedule 2 or 3 substance or other Schedule 4 substance—Tier 4 penalty, or

  • (d)

    otherwise—the prescribed penalty.

Note—

The Drug Misuse and Trafficking Act 1985 also prohibits the supply of prohibited drugs and prohibited scheduled substances. There is an exception for supply authorised under this Act.

37Prescriptions issued by health practitioners and veterinary practitioners(1)

This section applies to the issue of a prescription for a Schedule 2, 3, 4 or 8 substance.

(2)

The issue of a prescription is authorised if it is issued by the following—

  • (a)

    a medical practitioner for medical treatment of a person,

  • (b)

    a nurse practitioner for treatment of a person,

  • (c)

    a dentist for dental treatment of a person,

  • (d)

    a veterinary practitioner for treatment of an animal,

  • (e)

    a nurse, midwife, podiatrist or optometrist if—

    • (i)

      the person’s registration has an endorsement of a kind specified in the Health Practitioner Regulation National Law, section 94 that the person is qualified to prescribe the substance or goods, and

    • (ii)

      the prescription is issued for a purpose for which the person is qualified,

  • (f)

    a prescribed health practitioner for treatment of a person.

Part 2.6Clinical trials38Application of Part(1)

This Part applies to prescribed Schedule 8 substances and Schedule 9 and 10 substances, subject to the regulations.

(2)

This Part also applies to other prescribed therapeutic goods.

Note—

Regulations under section 11 may—

  • (a)

    exclude scheduled substances or other therapeutic goods from the operation of this Part, and

  • (b)

    apply this Part to other scheduled substances or therapeutic goods.

39Authorisation of clinical trials(1)

The Health Secretary may authorise a person, or a class of persons, to carry out an activity involving a scheduled substance or other prescribed therapeutic goods for the purposes of a clinical trial.

(2)

The carrying out of the activity is authorised if it is carried out in accordance with—

  • (a)

    conditions imposed by the Health Secretary, and

  • (b)

    the prescribed requirements.

Part 2.7Offences40Offence—loss or theft of Schedule 4D or 8 substances(1)

A person authorised under this Act to supply a Schedule 4D or 8 substance must notify the Health Secretary immediately after becoming aware that—

  • (a)

    the person has lost the substance, or

  • (b)

    the substance has been stolen, or

  • (c)

    a prescribed event involving the substance has occurred.

Maximum penalty—Tier 5 penalty.

(2)

The regulations may provide for notifications under this section, including the circumstances in which notification is not required.

41Offence—possessing Schedule 7 substances for domestic use(1)

A person must not possess a Schedule 7 substance for domestic use.

Maximum penalty—Tier 4 penalty.

(2)

It is not an offence under this section if the possession or use of the Schedule 7 substance is authorised under the Pesticides Act 1999.

42Offences—automatic machines for supplying certain therapeutic goods(1)

A person must not, in premises under the person’s control or in or at another place—

  • (a)

    install an automatic machine for the supply of scheduled substances or therapeutic goods that do not contain a scheduled substance (applicable goods), or

  • (b)

    supply applicable goods using an automatic machine.

Maximum penalty—Tier 5 penalty.

(2)

A person who occupies or controls premises is guilty of an offence if—

  • (a)

    an automatic machine for the supply of applicable goods is installed on the premises, or

  • (b)

    applicable goods are stored in an automatic machine installed on the premises, or

  • (c)

    applicable goods are supplied using an automatic machine.

Maximum penalty—Tier 5 penalty.

(3)

Subsections (1) and (2) do not apply to the supply of applicable goods to or by an authorised practitioner for the treatment of a patient.

(4)

The Health Secretary may, by order published in the Gazette, exempt a person or class of persons, or applicable goods or class of applicable goods, from the operation of subsection (1) or (2).

(5)

An order under subsection (4) may be made with or without conditions.

(6)

In this section—

automatic machine means a machine or mechanical device used, or capable of being used, for the purposes of supplying goods to members of the public without the personal manipulation or attention of the supplier or the supplier’s employee or other agent at the time of supply.

43Offence—supplying certain therapeutic goods at houses or in public places(1)

A person must not—

  • (a)

    go from house to house supplying scheduled substances or therapeutic goods that do not contain a scheduled substance (applicable goods), or

  • (b)

    supply applicable goods on a road or at another public place.

Maximum penalty—Tier 5 penalty.

(2)

The Health Secretary may, by order published in the Gazette, exempt a person or class of persons, or applicable goods or class of applicable goods, from the operation of this section.

(3)

An order under subsection (2) may be made with or without conditions.

(4)

In this section—

house means premises where persons reside, whether or not permanently.

road means a road or road related area within the meaning of the Road Transport Act 2013.

44Offence—administration or non-wholesale supply of unregistered or unlisted therapeutic goods(1)

A person must not administer or supply therapeutic goods for use in or on humans unless the goods are—

  • (a)

    registered goods, or

  • (b)

    listed goods, or

  • (c)

    subject to an approval, authority or exemption under the Commonwealth Therapeutic Goods Act, Chapter 3 or 4.

Maximum penalty—Tier 5 penalty.

(2)

This section does not apply to the following—

  • (a)

    the supply of therapeutic goods that are medical devices, other than medical devices that contain scheduled substances,

  • (b)

    the administration or supply of therapeutic goods by a person who is a sponsor,

  • (c)

    the administration or supply of therapeutic goods by a carer of another person to the extent the goods are—

    • (i)

      a Schedule 2 or 3 substance, or

    • (ii)

      a Schedule 4 or 8 substance dispensed on a prescription by a pharmacist or supplied by an authorised practitioner for the other person,

  • (d)

    the self-administration of therapeutic goods by a person,

  • (e)

    the wholesale supply of therapeutic goods,

    Note—

    See the Commonwealth Therapeutic Goods Act, section 21 for an offence relating to wholesale supply of unregistered or unlisted therapeutic goods.

  • (f)

    the administration or supply of prescribed therapeutic goods in prescribed circumstances,

  • (g)

    the administration or supply of therapeutic goods if—

    • (i)

      the registration or listing has been suspended under the Commonwealth Therapeutic Goods Act, and

    • (ii)

      the Secretary under the Commonwealth Therapeutic Goods Act has not required the therapeutic goods to be recalled under that Act.

(3)

In this section—

listed goods, registered goods and sponsor have the same meaning as in the Commonwealth Therapeutic Goods Act.

45Offence—supply of expired therapeutic goods(1)

A person must not, without reasonable excuse, supply scheduled substances or therapeutic goods that do not contain a scheduled substance (applicable goods) after the expiry date stated on or in relation to the applicable goods in accordance with a standard that applies to the applicable goods.

Maximum penalty—Tier 5 penalty.

(2)

A standard applies to applicable goods for subsection (1) if the standard is—

  • (a)

    a standard specified in an order under the Commonwealth Therapeutic Goods Act that applies to the goods, or

  • (b)

    if no order applies to the goods under the Commonwealth Therapeutic Goods Act but there is a relevant monograph about the goods—a standard specified in the relevant monograph.

(3)

This section applies only to a person who supplies applicable goods in the course of practising the person’s profession or employment.

(4)

In this section—

relevant monograph means—

  • (a)

    for applicable goods for use in or on humans—a monograph in the British, European or United States Pharmacopoeia, or

  • (b)

    for applicable goods for use in or on animals—a monograph in the British Pharmacopoeia (Veterinary) or United States Pharmacopoeia (Veterinary).

46Offence—dispensing or compounding scheduled substances on prescription

A person must not dispense or compound a scheduled substance on a prescription issued by an authorised practitioner unless the person is a pharmacist.

Maximum penalty—Tier 4 penalty.

47Offence—obtaining scheduled substances by false representation(1)

A person must not, by a representation the person knows, or ought reasonably to know, is false or misleading, obtain, or attempt to obtain, a scheduled substance from the following—

  • (a)

    an authorised practitioner,

  • (b)

    a pharmacist,

  • (c)

    a nurse, midwife, podiatrist or optometrist whose registration has an endorsement of a kind specified in the Health Practitioner Regulation National Law, section 94 that the person is qualified to possess, use or supply the scheduled substance,

  • (d)

    the holder of a wholesaler licence or obtain licence,

  • (e)

    another person authorised under this Act to obtain, supply or administer the scheduled substance.

Maximum penalty—Tier 5 penalty.

(2)

This section does not apply to—

  • (a)

    a prohibited drug, or

  • (b)

    a prohibited scheduled substance.

48Defence for delivering or transporting substances

This Act does not make it unlawful for a person to possess, supply or wholesale supply a scheduled substance or other prescribed therapeutic goods if—

  • (a)

    the person obtained the substance or goods from a person who is lawfully supplying or wholesale supplying the substance or goods (the lawful supplier) to another person who is authorised to obtain the substance or goods (the recipient), and

  • (b)

    the person is employed or engaged by the lawful supplier to deliver or transport the substance or goods to the recipient, and

  • (c)

    the possession or supply is only in connection with delivering or transporting the substance or goods to the recipient.

Part 2.8Restriction orders49Health Secretary may make restriction orders(1)

The Health Secretary may, by written order (a restriction order) given to a person, prohibit or restrict the person from carrying out an activity that the person is authorised to do under this Chapter, including possessing, supplying, wholesale supplying, obtaining wholesale supply, administering, dispensing, using, prescribing, manufacturing, storing or disposing of scheduled substances or other prescribed therapeutic goods.

(2)

An activity is not authorised under this Act if it is carried out in contravention of a restriction order.

(3)

A restriction order may, without limitation, prohibit or restrict an activity—

  • (a)

    by reference to specified therapeutic goods, circumstances, factors or exceptions, or

  • (b)

    unless it is carried out in a specified way, or

  • (c)

    generally or by reference to one or more classes or subclasses of activities.

(4)

A restriction order may be made subject to conditions.

(5)

A person must not contravene a restriction order applying to the person.

Maximum penalty for subsection (5)—Tier 3 penalty.

50Grounds on which restriction orders may be made(1)

A restriction order may be made in relation to a person on one or more of the following grounds—

  • (a)

    the person has made a written request for the order,

  • (b)

    the person has been charged or convicted of an offence against—

    • (i)

      this Act or the regulations, or

    • (ii)

      the repealed Poisons and Therapeutic Goods Act 1966, or

    • (iii)

      a relevant law,

  • (c)

    the Health Secretary considers the person has previously contravened a restriction order,

  • (d)

    the person is a health practitioner who has given an undertaking under the Health Practitioner Regulation National Law or whose registration is subject to a condition or restriction under that Law,

  • (e)

    the person is a veterinary practitioner whose registration under the Veterinary Practice Act 2003 is subject to a condition or limitation under that Act,

  • (f)

    the Health Secretary considers the person is someone who should be restricted or prohibited from carrying out the activity for the purposes of protecting the health or safety of the person or another person, whether or not the other person is identifiable,

  • (g)

    other prescribed grounds.

(2)

A restriction order must specify the grounds on which the order is made.

51Making restriction orders(1)

A restriction order must specify the day on which it takes effect.

(2)

Unless earlier revoked, a restriction order has effect for the period, if any, specified in the order.

(3)

A restriction order must be published in the Gazette as soon as practicable after the order is made.

(4)

Failure to comply with subsection (3) does not invalidate the restriction order.

52Restriction orders for health practitioners(1)

As soon as practicable after making a restriction order applying to a health practitioner, the Health Secretary must notify the Council under the Health Practitioner Regulation National Law (NSW) for the person’s health profession.

(2)

Before amending or revoking a restriction order applying to a health practitioner, the Health Secretary must consult with the Council under the Health Practitioner Regulation National Law (NSW) for the person’s health profession.

(3)

Subsection (1) does not apply to a restriction order made under section 50(1)(a).

53Review of restriction orders(1)

A person to whom a restriction order applies may apply to the Health Secretary for a review of the decision to make the restriction order.

(2)

The Health Secretary may refuse to review a decision to make a restriction order if the Health Secretary—

  • (a)

    has reviewed the decision within the previous 6 months, and

  • (b)

    is not satisfied there has been a material change in relevant circumstances.

Part 2.9Miscellaneous54Regulations about scheduled substances used for cosmetic purposes(1)

The regulations may prescribe requirements about the possession, manufacture, supply, use, prescription, administration, storage and disposal of scheduled substances used for cosmetic purposes.

(2)

Without limiting subsection (1), the regulations may provide that a prescribed requirement is a category 1 requirement or category 2 requirement.

(3)

A person must not contravene a category 1 requirement or category 2 requirement.

Maximum penalty for subsection (3)—

  • (a)

    for a category 1 requirement—Tier 2 penalty, or

  • (b)

    for a category 2 requirement—Tier 4 penalty.

55Regulations about activities involving certain therapeutic goods and preparations(1)

The regulations may provide for prohibiting or otherwise regulating activities in connection with the following—

  • (a)

    the manufacture, compounding, supply, administration, possession or use of the following (applicable goods)—

    • (i)

      scheduled substances,

    • (ii)

      therapeutic goods that are not scheduled substances,

    • (iii)

      sterile compounded preparations,

  • (b)

    the issue of prescriptions for applicable goods,

  • (c)

    the storage, labelling and packaging of applicable goods,

  • (d)

    the preparation and handling of applicable goods, including the use and condition of the premises used for the preparation and handling,

  • (e)

    the provision of access to applicable goods,

  • (f)

    record keeping in relation to applicable goods, including the keeping of registers for applicable goods,

  • (g)

    the destruction of applicable goods.

(2)

Despite subsection (1), the regulations cannot prohibit the manufacture or compounding of applicable goods or sterile compounded preparations.

(3)

The power to make regulations under this section is not limited by other provisions of this Chapter prohibiting or regulating, or authorising regulations to prohibit or regulate, activities of the kind specified in this section.

(4)

In this section—

sterile compounded preparation means a compound of substances, whether or not containing scheduled substances, that is required to be kept sterile, and includes a preparation in—

  • (a)

    parenteral dosage form, other than an intradermal or subcutaneous injection of an allergen extract, and

  • (b)

    ophthalmic dosage form.

Chapter 3Licences, approvals and other authorisationsPart 3.1Introduction56Application of Chapter(1)

This Chapter provides for the following authorisations

  • (a)

    wholesaler licences,

  • (b)

    obtain licences,

  • (c)

    approvals,

  • (d)

    OTP registrations,

  • (e)

    DMT authorities.

(2)

An activity is authorised under this Act if it is carried out in accordance with—

  • (a)

    an authorisation, and

  • (b)

    the terms and conditions, limitations and other restrictions that apply in relation to carrying out the activity.

Note—

Activities may also be authorised under Chapter 2 or the regulations.

(3)

An authorisation is not transferable.

(4)

To avoid doubt, subsection (3) does not prevent a person from carrying out an activity relying on an authorisation granted to another person if another provision of this Act, or a provision of the regulations, authorises the reliance.

(5)

An authorisation may apply, adopt or incorporate, wholly or in part and with or without modification, a standard, rule, code, specification, method or publication, as in force at a particular time or as in force from time to time, prescribed or published by an authority or body, whether or not it is a New South Wales authority or body.

Part 3.2Licences for wholesale supply and obtaining wholesale supply of certain therapeutic goodsDivision 1Granting of wholesaler licences and obtain licences57Wholesaler licences and obtain licences(1)

The Health Secretary may, on application or the Health Secretary’s own initiative, grant a licence (a wholesaler licence) that authorises a person to wholesale supply specified scheduled substances or other prescribed therapeutic goods.

(2)

The Health Secretary may, on application or the Health Secretary’s own initiative, grant a licence (an obtain licence) that authorises a person as follows—

  • (a)

    to obtain wholesale supply of specified scheduled substances or other prescribed therapeutic goods for use by one or more of the following—

    • (i)

      a provider under the Opioid Treatment Program,

    • (ii)

      a corporation that provides paramedical services,

    • (iii)

      a person providing ambulance transport with the consent of the Health Secretary under the Health Services Act 1997, section 67E,

    • (iiia)

      a person providing ambulance transport who is exempt from the requirement to obtain the consent of the Health Secretary under the Health Services Act 1977, section 67E,

    • (iv)

      a person engaged in the administration of a vaccination program for humans,

    • (v)

      a person on behalf of a university,

    • (vi)

      a person on behalf of a prescribed research institution, other than a university,

    • (vii)

      a person on behalf of an analytical or research and development laboratory,

  • (b)

    to obtain a prescribed Schedule 7 substance,

  • (c)

    to obtain a prescribed Schedule 10 substance that is not a prohibited drug,

  • (d)

    to obtain prescribed therapeutic goods for a prescribed purpose.

(3)

In this Part—

licence means a wholesaler licence or an obtain licence.

s 57: Am 2025 No 48, Sch 1.8[1].

58Grounds for granting licence(1)

The Health Secretary may grant a licence if satisfied of all the following—

  • (a)

    the applicant is a fit and proper person to hold the licence,

  • (b)

    for an application for a licence for a Schedule 9 substance—the licence is intended for—

    • (i)

      medical or scientific research purposes, or

    • (ii)

      analysis, teaching or training purposes, or

    • (iii)

      a prescribed industrial purpose,

  • (c)

    for an application for a licence for a prescribed Schedule 7 substance—the licence is intended only for supply or obtaining supply for non-domestic use,

  • (d)

    for an application for a licence for a prescribed Schedule 7 substance marked with an “a” in the NSW Poisons List—the licence is intended only for supply or obtaining supply for an analytical or research purpose,

  • (e)

    for an application for a licence for a Schedule 9 substance, a prescribed Schedule 7 substance marked with a “p” in the NSW Poisons List or a Schedule 10 substance—the granting of the licence would not pose an unacceptable risk to public health,

  • (f)

    other prescribed matters, whether generally or for particular kinds of applications.

(2)

The Health Secretary may grant a licence, even if the Health Secretary is not satisfied of all of the matters specified in subsection (1), if the Health Secretary considers it necessary to grant the licence to deal with urgent, emergency or unforeseen circumstances.

(3)

To avoid doubt, the Health Secretary may refuse to grant a licence to an applicant even if the Health Secretary is satisfied of all the matters specified in subsection (1).

59Application for licence(1)

A person may apply to the Health Secretary for a licence.

(2)

An application must—

  • (a)

    be in an approved form, and

  • (b)

    be accompanied by the prescribed application fee, if any, and

  • (c)

    include or be accompanied by information or evidence the Health Secretary reasonably requires to assess the application.

Note—

The Crimes Act 1900, Part 5A contains offences relating to the making of false or misleading applications or providing false or misleading information or documents. The offences have a maximum penalty of imprisonment for 2 years or a $22,000 fine, or both.

(3)

The Health Secretary must give the person written notice of a decision to grant or refuse a licence within the prescribed period.

(4)

If the Health Secretary fails to give notice within the prescribed period, the Health Secretary is taken to have refused to grant the licence.

Note—

See also section 83, which enables the Health Secretary to require an applicant to provide further information in relation to an application. The Health Secretary may refuse to deal with the application until the information is provided and may reject the application after 6 months.

60Conditions of licence(1)

A licence is subject to any conditions imposed by the Health Secretary—

  • (a)

    at the time of the grant of the licence, or

  • (b)

    at another time by variation of the licence.

(2)

The conditions of a licence may provide that the licence does not take effect until—

  • (a)

    the end of a specified period, or

  • (b)

    a specified event happens, or

  • (c)

    a specified state of affairs occurs.

(3)

A licence holder must not contravene a condition of the licence.

Maximum penalty for subsection (3)—Tier 5 penalty.

61Variation of licence(1)

The Health Secretary may, by written notice to a licence holder, vary the licence, including the conditions of the licence.

(2)

A variation of a licence includes the following—

  • (a)

    the imposition of a new licence condition,

  • (b)

    the substitution of a licence condition,

  • (c)

    the removal or amendment of a licence condition.

(3)

The regulations may provide for—

  • (a)

    applications for variations of licences by licence holders, and

  • (b)

    the grounds for the variation of licences.

62Annual fee for licence(1)

A licence holder must in each year, on or before 30 September or other date notified in writing by the Health Secretary to the licence holder, pay the prescribed annual fee, if any, to the Health Secretary.

(2)

An annual fee is not payable for the year during which the licence was granted.

(3)

The Health Secretary may accept payment of an annual fee up to 3 months after the date required under subsection (1), if an additional late fee of 50% of the annual fee is paid at the same time as the annual fee.

Division 2Suspension or cancellation of wholesaler licences and obtain licences63Mandatory grounds for suspension or cancellation of licence

The Health Secretary must suspend or cancel a licence—

  • (a)

    if the licence holder requests or agrees to the suspension or cancellation, or

  • (b)

    if the licence holder is convicted of an offence against a relevant law that is punishable by imprisonment for 5 years or more, or

  • (c)

    if the Health Secretary considers the licence holder is no longer a fit and proper person to hold the licence, or

  • (d)

    on other prescribed grounds.

64Discretionary grounds for suspension or cancellation of licence

The Health Secretary may suspend or cancel a licence on one or more of the following grounds—

  • (a)

    the licence holder contravenes a condition of the licence,

  • (b)

    the licence holder is charged with an offence against this Act, the regulations or a relevant law,

  • (c)

    the licence holder is convicted of an offence against this Act or the regulations,

  • (d)

    the licence holder is convicted of an offence against a relevant law, other than an offence that is punishable by imprisonment for 5 years or more,

  • (e)

    an order is made under the Crimes (Sentencing Procedure) Act 1999, section 10(1) relating to the licence holder for an offence against this Act, the regulations or a relevant law,

  • (f)

    the licence holder has made a representation in connection with the licence, including in connection with an application for the licence, that is false or misleading in a material particular,

  • (g)

    the prescribed annual fee, if any, and any late fee, for the licence has not been paid in accordance with section 62,

  • (h)

    other prescribed grounds.

65Submissions about suspension or cancellation of licence on discretionary grounds(1)

Before suspending or cancelling a licence under section 64, the Health Secretary must give written notice to the licence holder of the Health Secretary’s intention to suspend or cancel the licence and the proposed grounds for the suspension or cancellation.

(2)

The notice must specify a period of at least 10 days in which the licence holder may make submissions to the Health Secretary about the proposed suspension or cancellation.

(3)

Before suspending or cancelling a licence under section 64, the Health Secretary must consider any submissions made within the specified period.

(4)

The Health Secretary is not required to comply with this section in relation to the suspension or cancellation of a licence if satisfied that—

  • (a)

    the time required to comply with this section would increase a risk to the health or safety of the public, or

  • (b)

    the suspension or cancellation is required for urgent or emergency reasons.

66Notice of suspension or cancellation of licence(1)

The Health Secretary must give written notice to a licence holder of the suspension or cancellation of the licence.

(2)

The notice must specify the following—

  • (a)

    the date or time from which the suspension or cancellation takes effect,

  • (b)

    the grounds for the suspension or cancellation,

  • (c)

    for a suspension—the period of suspension.

Part 3.3Approvals for supply and prescription of certain therapeutic goods by health practitioners67Application of Part(1)

This Part applies to prescribed Schedule 8 substances and other prescribed therapeutic goods.

(2)

A reference in a provision in this Part to scheduled substances or therapeutic goods is a reference to the scheduled substances and prescribed therapeutic goods to which the provision applies.

68Granting of approval(1)

The Health Secretary may, subject to the regulations, grant an approval that authorises—

  • (a)

    the supply or administration of scheduled substances or other prescribed therapeutic goods by a health practitioner or veterinary practitioner, or class of health practitioner or veterinary practitioner, specified in section 29, or

  • (b)

    the issue of a prescription for scheduled substances or other prescribed therapeutic goods by a health practitioner, or class of health practitioner, specified in section 37.

(2)

An approval may be granted on application or the Health Secretary’s own initiative.

(3)

An approval may be granted to authorise an activity referred to in subsection (1)(a) or (b) if—

  • (a)

    the activity is subject to prescribed restrictions, and

  • (b)

    the regulations require an approval for the activity to be authorised under this Act.

(4)

The regulations may provide for the circumstances in which an approval, or kind of approval, may or must be granted or refused.

(5)

An approval may be granted to a particular person or a class of persons.

(6)

An approval is granted to a class of persons by written notice published on the Ministry of Health’s website.

(7)

The Health Secretary must specify the term of an approval when granting the approval.

69Offence—supplying or issuing prescriptions for therapeutic goods without approval(1)

A health practitioner or veterinary practitioner must not in prescribed circumstances—

  • (a)

    supply or administer scheduled substances or other therapeutic goods without an approval, or

  • (b)

    issue a prescription for scheduled substances or other therapeutic goods without an approval.

Maximum penalty—Tier 5 penalty.

(2)

This section does not apply to a health practitioner—

  • (a)

    acting under the direction of another health practitioner who is authorised under an approval, or

  • (b)

    carrying out an activity authorised under Part 2.6, or

  • (c)

    carrying out an activity under an OTP registration.

(3)

This section does not apply to a veterinary practitioner—

  • (a)

    acting under the direction of another veterinary practitioner who is authorised under an approval, or

  • (b)

    carrying out an activity authorised under Part 2.6.

s 69: Am 2023 No 7, Sch 1.13[1] [2].

70Application for approval(1)

A person may apply to the Health Secretary for an approval.

(2)

An application must—

  • (a)

    be in an approved form, and

  • (b)

    include or be accompanied by information or evidence the Health Secretary reasonably requires to assess the application.

Note—

The Crimes Act 1900, Part 5A contains offences relating to the making of false or misleading applications or providing false or misleading information or documents. The offences have a maximum penalty of imprisonment for 2 years or a $22,000 fine, or both.

(3)

The Health Secretary must give the applicant written notice of a decision to grant or refuse an approval within the prescribed period.

(4)

If the Health Secretary fails to give notice within the prescribed period, the Health Secretary is taken to have refused the application.

Note—

Section 83 enables the Health Secretary to require an applicant to provide further information in relation to an application. The Health Secretary may refuse to deal with the application until the information is provided and may reject the application after 6 months.

71Conditions of approval(1)

An approval is subject to conditions imposed by the Health Secretary—

  • (a)

    at the time of the grant of the approval, or

  • (b)

    at another time by variation of the approval.

(2)

The conditions of an approval may provide that the approval does not take effect until—

  • (a)

    the end of a specified period, or

  • (b)

    a specified event happens, or

  • (c)

    a specified state of affairs occurs.

(3)

An approval holder must not contravene a condition of the approval.

Maximum penalty for subsection (3)—Tier 5 penalty.

72Variation of approval(1)

The Health Secretary may, by written notice, vary an approval, including the conditions of the approval.

(2)

A variation of an approval includes the following—

  • (a)

    the imposition of a new approval condition,

  • (b)

    the substitution of an approval condition,

  • (c)

    the removal or amendment of an approval condition.

(3)

The notice must be—

  • (a)

    for an approval granted to a particular person—given to the approval holder, or

  • (b)

    for an approval granted to a class of persons—published on the Ministry of Health’s website.

(4)

The regulations may provide for—

  • (a)

    applications for variations of approvals by approval holders, and

  • (b)

    the grounds for the variation of approvals.

73Suspension or revocation of approval(1)

The Health Secretary may, subject to the regulations, suspend or revoke an approval for reasons the Health Secretary considers appropriate.

(2)

The regulations may provide for the circumstances in which an approval, or kind of approval, may or must be suspended or revoked.

(3)

An approval granted to a class of persons may be suspended or revoked in its application to—

  • (a)

    all the persons of the class, or

  • (b)

    specified persons of the class.

(4)

Notice of the suspension or revocation of an approval must—

  • (a)

    be written, and

  • (b)

    specify the following—

    • (i)

      the date or time from which the suspension or revocation takes effect,

    • (ii)

      the grounds for the suspension or revocation,

    • (iii)

      for a suspension—the period of suspension.

(5)

Notice of the suspension or revocation of an approval granted to a particular person must be given to the person.

(6)

Notice of the suspension or revocation of an approval granted to a class of persons must be—

  • (a)

    if the suspension or revocation applies to all the persons of the class—published on the Ministry of Health’s website, or

  • (b)

    if the suspension or revocation applies to a specified person of the class—given to the person.

Part 3.4Opioid Treatment Program74Registration in Opioid Treatment Program(1)

The Health Secretary may, in accordance with the regulations, register a medical practitioner, nurse practitioner or pharmacy to carry out activities involving the following as part of the Opioid Treatment Program (an OTP registration)—

  • (a)

    the supply or administration by a medical practitioner or nurse practitioner of a prescribed Schedule 8 substance or other prescribed scheduled substance,

  • (b)

    the issue of a prescription by a medical practitioner or nurse practitioner for a prescribed Schedule 8 substance or other prescribed scheduled substance,

  • (c)

    the dispensing of a prescribed Schedule 8 substance or other prescribed scheduled substance by a pharmacist at a pharmacy.

(2)

An OTP registration for a pharmacy under subsection (1)(c) applies only to dispensing on a prescription issued by a medical practitioner or nurse practitioner with an OTP registration under subsection (1)(b).

(3)

The regulations may provide for OTP registrations, including the following—

  • (a)

    the circumstances in which registrations, or kinds of registrations, may or must be granted or refused,

  • (b)

    the activities that medical practitioners, nurse practitioners, pharmacists and pharmacies are authorised to do under a registration,

  • (c)

    the variation, suspension or revocation of registrations,

  • (d)

    the provision of information about persons for the purposes of registrations, including information about whether persons are registrable,

  • (e)

    the keeping and publication of registers for registrations,

  • (f)

    the circumstances in which an OTP registration is not required, including in relation to particular medical practitioners, nurse practitioners, pharmacies, pharmacists and patients.

(4)

The regulations may provide for standards that must be complied with by the following—

  • (a)

    a person who supplies, administers or issues prescriptions for a prescribed Schedule 8 substance or other prescribed scheduled substance under an OTP registration,

  • (b)

    a pharmacist who dispenses a prescribed Schedule 8 substance or other prescribed scheduled substance at a pharmacy under an OTP registration,

  • (c)

    a provider who is the holder of an obtain licence as referred to in section 57(2)(a)(i),

  • (d)

    another prescribed person.

75Offence—supplying, dispensing or issuing prescriptions for certain scheduled substances without OTP registration(1)

A medical practitioner or nurse practitioner must not, without an OTP registration—

  • (a)

    supply or administer a prescribed Schedule 8 substance or other prescribed scheduled substance, or

  • (b)

    issue a prescription for a prescribed Schedule 8 substance or other prescribed scheduled substance.

Maximum penalty—Tier 5 penalty.

(2)

Subsection (1) does not apply to a person acting under the direction of a medical practitioner or nurse practitioner who has an OTP registration.

(3)

A pharmacist must not dispense a prescribed Schedule 8 substance or other prescribed scheduled substance from a pharmacy that does not have an OTP registration.

Maximum penalty—Tier 5 penalty.

Part 3.5Authorities for Drug Misuse and Trafficking Act 198576Granting of DMT authority(1)

The Health Secretary may, on application or the Health Secretary’s own initiative, grant an authority to a person or class of persons for the purposes of the Drug Misuse and Trafficking Act 1985 (a DMT authority).

Note—

The Drug Misuse and Trafficking Act 1985 enables a person to carry out certain activities involving prohibited drugs or prohibited plants if carried out in accordance with a DMT authority.

(2)

A DMT authority may authorise a person or class of persons to—

  • (a)

    do one or more of the following with a prohibited drug, prohibited scheduled substance or prohibited plant for a relevant purpose—

    • (i)

      possess the drug, substance or plant,

    • (ii)

      manufacture, produce or cultivate the drug, substance or plant,

    • (iii)

      supply the drug, substance or plant,

    • (iv)

      administer the drug, substance or plant, and

  • (b)

    without limiting paragraph (a)—possess a prohibited drug, prohibited scheduled substance or prohibited plant for the purposes of the person’s profession or employment.

(3)

The Health Secretary must not grant a DMT authority in relation to the following—

  • (a)

    the possession, manufacture, production, cultivation or supply of low-THC hemp,

  • (b)

    the possession, manufacture, production, cultivation or supply of alkaloid poppies,

  • (c)

    the manufacture of a prohibited drug using alkaloid poppy material.

(4)

A DMT authority may be granted to—

  • (a)

    a particular person, or

  • (b)

    a class of persons.

(5)

A DMT authority is granted to a class of persons by written notice published on the Ministry of Health’s website.

(6)

In this section—

alkaloid poppy and alkaloid poppy material have the same meaning as in the Poppy Industry Act 2016.

low-THC hemp has the same meaning as in the Hemp Industry Act 2008.

prohibited plant has the same meaning as in the Drug Misuse and Trafficking Act 1985.

relevant purpose means the following purposes—

  • (a)

    medical or scientific research,

  • (b)

    analysis, teaching or training,

  • (c)

    a prescribed purpose.

s 76: Am 2025 No 62, Sch 12[1].

77Application for DMT authority(1)

A person may apply to the Health Secretary for a DMT authority.

(2)

An application must—

  • (a)

    be in an approved form, and

  • (b)

    be accompanied by the prescribed application fee, if any, and

  • (c)

    include or be accompanied by information or evidence the Health Secretary reasonably requires to assess the application.

Note—

The Crimes Act 1900, Part 5A contains offences relating to the making of false or misleading applications or providing false or misleading information or documents. The offences have a maximum penalty of imprisonment for 2 years or a $22,000 fine, or both.

(3)

The Health Secretary must give the applicant written notice of a decision to grant or refuse a DMT authority within the prescribed period.

(4)

If the Health Secretary fails to give notice within the prescribed period, the Health Secretary is taken to have refused the application.

Note—

Section 83 enables the Health Secretary to require an applicant to provide further information in relation to an application. The Health Secretary may refuse to deal with the application until the information is provided and may reject the application after 6 months.

78Duration of DMT authority(1)

A DMT authority has a term of 3 years unless the Health Secretary—

  • (a)

    specifies a different term when granting the DMT authority, or

  • (b)

    extends the term before the end of the term.

(2)

A DMT authority remains in force until the DMT authority—

  • (a)

    expires, or

  • (b)

    is sooner revoked or surrendered.

(3)

A DMT authority has no effect during a period in which the DMT authority is suspended.

79Conditions of DMT authority(1)

A DMT authority is subject to—

  • (a)

    prescribed conditions, and

  • (b)

    conditions imposed by the Health Secretary—

    • (i)

      at the time of the grant of the DMT authority, or

    • (ii)

      at another time by variation of the DMT authority.

(2)

The conditions of a DMT authority may provide the DMT authority does not take effect until—

  • (a)

    the end of a specified period, or

  • (b)

    a specified event happens, or

  • (c)

    a specified state of affairs occurs.

(3)

The holder of a DMT authority must not contravene a condition of the DMT authority.

Maximum penalty for subsection (3)—Tier 5 penalty.

80Variation of DMT authority(1)

The Health Secretary may, by written notice, vary a DMT authority, including any conditions imposed on the DMT authority by the Health Secretary.

(2)

A variation of a DMT authority includes the following—

  • (a)

    the imposition of a new condition on the DMT authority,

  • (b)

    the substitution of a condition of the DMT authority,

  • (c)

    the removal or amendment of a condition of the DMT authority.

(3)

The notice must be—

  • (a)

    for a DMT authority granted to a particular person—given to the holder of the DMT authority, or

  • (b)

    for a DMT authority granted to a class of persons—published on the Ministry of Health’s website.

(4)

The regulations may provide for—

  • (a)

    applications for variations of DMT authorities, and

  • (b)

    the grounds for variations of DMT authorities.

81Suspension or revocation of DMT authority(1)

The Health Secretary may, subject to the regulations, suspend or revoke a DMT authority for reasons the Health Secretary considers appropriate.

(2)

The regulations may provide for the circumstances in which a DMT authority, or kind of DMT authority, may or must be suspended or revoked.

(3)

A DMT authority granted to a class of persons may be suspended or revoked in its application to—

  • (a)

    all the persons of the class, or

  • (b)

    specified persons of the class.

(4)

Notice of a suspension or revocation of a DMT authority must—

  • (a)

    be written, and

  • (b)

    specify the following—

    • (i)

      the date or time from which the suspension or revocation takes effect,

    • (ii)

      the grounds for the suspension or revocation,

    • (iii)

      for a suspension—the period of suspension.

(5)

Notice of a suspension or revocation of a DMT authority granted to a particular person must be given to the person.

(6)

Notice of a suspension or revocation of a DMT authority granted to a class of persons must be—

  • (a)

    for a suspension or revocation applying to all the persons of the class—published on the Ministry of Health’s website, or

  • (b)

    for a suspension or revocation applying to a specified person of the class—given to the person.

Part 3.6MiscellaneousDivision 1Investigation of applications for licences, approvals and DMT authorities82Application of Division

This Division applies to an application for the following—

  • (a)

    a wholesaler licence,

  • (b)

    an obtain licence,

  • (c)

    an approval,

  • (d)

    a DMT authority.

83Information about applications for licences, approvals and DMT authorities(1)

The Health Secretary may, by written notice, require an applicant to do one or more of the following—

  • (a)

    provide relevant information that was not included in the application,

  • (b)

    provide documentary or other evidence in support of relevant information included in the application or later provided to the Health Secretary,

    Example—

    A photograph of the applicant.

  • (c)

    authorise a person specified in the notice to provide the relevant information specified in the notice,

  • (d)

    authorise a person specified in the notice to—

    • (i)

      produce, in accordance with directions in the notice, relevant records specified in the notice, and

    • (ii)

      permit the examination of the records, the taking of extracts from the records and the making of copies of the records,

  • (e)

    provide the Health Secretary with the authorities and consents required by the Health Secretary for the purposes of enabling the Health Secretary to obtain relevant information, including financial and other confidential information, from other persons about the applicant.

(2)

If a requirement made under this section is not complied with, the Health Secretary may—

  • (a)

    refuse to consider the application while the non-compliance continues, and

  • (b)

    if the non-compliance continues for 6 months or more—refuse the application without dealing with it further.

(3)

A person who complies with a requirement of a notice under this section does not incur a liability to another person because of the compliance.

(4)

In this section—

relevant, in relation to information or records, means information or records that are relevant to the Health Secretary’s investigation of an application.

84Investigation of applications for licences, approvals and DMT authorities

If the Health Secretary receives an application, the Health Secretary may—

  • (a)

    carry out, or arrange for the carrying out of, investigations and inquiries in relation to the application that the Health Secretary considers necessary for a proper consideration of the application, and

  • (b)

    seek information or advice from a person with functions under corresponding Australian legislation relating to the authorisation of persons to carry out activities to which the application relates, and

  • (c)

    refer an application, including supporting information, to the Regulatory Advisory Committee or Clinical Advisory Committee for advice.

Division 2Fees85Fees for licences, approvals, OTP registrations and DMT authorities(1)

The regulations may provide for fees in connection with the following—

  • (a)

    wholesaler and obtain licences,

  • (b)

    approvals,

  • (c)

    OTP registrations,

  • (d)

    DMT authorities.

(2)

Fees include the following—

  • (a)

    application fees,

  • (b)

    annual fees,

  • (c)

    fees for variations or extensions of licences, approvals, OTP registrations and DMT authorities.

(3)

The regulations may provide for the reduction, postponement, waiver or refund of fees, including by providing for the Health Secretary to reduce, postpone, waive or refund the fees.

(4)

The regulations may provide for fees to be not payable by specified persons or classes of persons.

Chapter 3ARegulation of vaping goods

ch 3A: Ins 2024 No 94, Sch 2[1].

Part 1Preliminary

ch 3A, pt 1: Ins 2024 No 94, Sch 2[1].

85ADefinitions

In this chapter—

Australian Register of Therapeutic Goods means the Australian Register of Therapeutic Goods kept under the Commonwealth therapeutic goods laws.

commercial quantity, of a kind of vaping goods, has the same meaning as in the Commonwealth Therapeutic Goods Act.

Commonwealth Minister means the Minister of the Commonwealth responsible for administering the Commonwealth therapeutic goods laws.

conformity assessment document has the same meaning as in the Commonwealth Therapeutic Goods Act.

section 41R determination means a determination made by the Commonwealth Minister under the Commonwealth Therapeutic Goods Act, section 41R authorising the supply or possession of vaping goods.

section 41RC consent means a consent given by the Commonwealth Secretary under the Commonwealth Therapeutic Goods Act, section 41RC(1) to manufacture, supply or possess vaping goods.

sponsor, in relation to therapeutic goods, has the same meaning as in the Commonwealth Therapeutic Goods Act.

vaping goods has the same meaning as in the Commonwealth Therapeutic Goods Act.

s 85A: Ins 2024 No 94, Sch 2[1].

Part 2Regulation of supply and possession of vaping goods

ch 3A, pt 2: Ins 2024 No 94, Sch 2[1].

85BProhibition on supplying vaping goods(1)

A person who supplies vaping goods in New South Wales is guilty of an offence.

Maximum penalty—7 years imprisonment or 14,000 penalty units, or both.

(2)

A person who supplies vaping goods in New South Wales is guilty of a strict liability offence.

Maximum penalty—560 penalty units.

(3)

Subsections (1) and (2) do not apply if—

  • (a)

    subsections (4)–(6) apply in relation to the supply of the vaping goods by the person, or

    Note—

    Subsections (4)–(6) together apply in relation to wholesale supply of vaping goods.

  • (b)

    subsections (4), (7) and (8) apply in relation to the supply of the vaping goods by the person.

    Note—

    Subsections (4), (7) and (8) together apply in relation to retail supply of vaping goods.

(4)

This subsection applies in relation to the supply of the vaping goods by the person if—

  • (a)

    the vaping goods are therapeutic goods included in the Australian Register of Therapeutic Goods, or

  • (b)

    both of the following apply—

    • (i)

      the vaping goods are therapeutic goods—

      • (A)

        that are exempt goods under regulations made under the Commonwealth Therapeutic Goods Act, section 18(1) or an exempt device under regulations made under the Commonwealth Therapeutic Goods Act, section 41HA(1), and

      • (B)

        in relation to which the sponsor has given the Commonwealth Secretary a notice in compliance with the exemption,

    • (ii)

      the vaping goods are not the subject of a determination by the Commonwealth Secretary, published on the Commonwealth Department’s website, that the supply of the goods be stopped or should be stopped because the Commonwealth Secretary is satisfied that the supply of the goods compromises public health and safety or the goods do not conform with a standard applicable to the goods, or

  • (c)

    the vaping goods are covered by a section 41R determination.

(5)

This subsection applies in relation to the supply of the vaping goods by the person if—

  • (a)

    the person is—

    • (i)

      the holder of a licence or permission, granted under regulations made under the Customs Act 1901 of the Commonwealth, section 50 to import the vaping goods, or

    • (ii)

      otherwise approved under those regulations to import the vaping goods, or

  • (b)

    the person is the holder of a licence under the Commonwealth Therapeutic Goods Act, Part 3-3 that—

    • (i)

      is in force, and

    • (ii)

      authorises a step in the manufacture of the vaping goods, or

  • (c)

    the person is the holder of a conformity assessment document that applies to the vaping goods, or

  • (d)

    both of the following apply—

    • (i)

      the person is a wholesaler who is the holder of an authorisation to supply one or more substances included in the NSW Poisons Schedules, Schedule 3,

    • (ii)

      the supply is in accordance with the licence or authority, or

  • (e)

    both of the following apply—

    • (i)

      the person has been given a section 41RC consent to supply the vaping goods,

    • (ii)

      the supply is in accordance with the consent, or

  • (f)

    if the vaping goods are covered by a section 41R determination—

    • (i)

      the person is specified in the determination, or is included in a class of persons specified in the determination, in relation to the vaping goods, and

    • (ii)

      the supply is in accordance with the determination.

(6)

This subsection applies in relation to the supply of the vaping goods by the person if—

  • (a)

    the person (the recipient) to whom the vaping goods are supplied is the holder of a licence under the Commonwealth Therapeutic Goods Act, Part 3-3 that—

    • (i)

      is in force, and

    • (ii)

      authorises a step in the manufacture of the vaping goods, or

  • (b)

    the recipient is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, to supply one or more substances included in the NSW Poisons Schedules, Schedule 3 under a law of the State or Territory in which the recipient carries on a business, practises or is employed, or

  • (c)

    the recipient has been given a section 41RC consent to supply the vaping goods, or

  • (d)

    if the vaping goods are covered by a section 41R determination—the recipient is specified in the determination, or is included in a class of persons specified in the determination, in relation to the vaping goods.

(7)

This subsection applies in relation to the supply of the vaping goods by the person if the person is a pharmacist, medical practitioner or nurse practitioner.

(8)

This subsection applies in relation to the supply of the vaping goods by the person if—

  • (a)

    the supply is—

    • (i)

      to another person for use by the other person for smoking cessation, management of nicotine dependence or another indication determined by the Commonwealth Minister under the Commonwealth Therapeutic Goods Act, section 41RA, or

    • (ii)

      to another person, who is the carer of a third person, for use by the third person for smoking cessation, management of nicotine dependence or another indication determined by the Commonwealth Minister under the Commonwealth Therapeutic Goods Act, section 41RA, and

  • (b)

    if the vaping goods are, or contain, a vaping substance—the vaping substance is in final dosage form, and

  • (c)

    the supply is—

    • (i)

      apart from this section, otherwise in accordance with this Act, and

    • (ii)

      consistent with the person’s authority to supply the vaping goods under a law of New South Wales.

(9)

For the purposes of paragraph (8)(b), a vaping substance is in final dosage form if the vaping substance is in a form that can be administered to a person without any change or modification other than vaporisation.

s 85B: Ins 2024 No 94, Sch 2[1].

85CProhibition on possession of vaping goods—commercial quantities(1)

A person is guilty of an offence if—

  • (a)

    the person possesses a quantity of a kind of vaping goods in New South Wales, and

  • (b)

    the quantity is at least the commercial quantity, but less than 100 times the commercial quantity, of the kind of vaping goods.

Maximum penalty—2 years imprisonment or 2,800 penalty units, or both.

(2)

A person is guilty of a strict liability offence if—

  • (a)

    the person possesses a quantity of a kind of vaping goods in New South Wales, and

  • (b)

    the quantity is at least the commercial quantity, but less than 100 times the commercial quantity, of the kind of vaping goods.

[16]Section 24A Possession of precursors and certain apparatus for manufacture or production of prohibited drugs

Omit section 24A(2)(a)–(b). Insert instead—

  • (a)

    a person authorised under the Medicines, Poisons and Therapeutic Goods Act 2022, including under a DMT authority under that Act, to manufacture or produce the prohibited drug, or

  • (b)

    a person acting under the authority of a licence, permit, exemption or other authorisation under Commonwealth drug legislation, or

  • (c)

    a person acting under a poppy licence under the Poppy Industry Act 2016.

  • [17]Section 25 Supply of prohibited drugs

    Omit section 25(4). Insert instead—

    (4)

    Nothing in this section renders the following unlawful—

    • (a)

      the supply of a prohibited drug by—

      • (i)

        a person authorised to supply the prohibited drug under the Medicines, Poisons and Therapeutic Goods Act 2022, including under a DMT authority under that Act, or

      • (ii)

        a person acting in accordance with a direction given by the Commissioner of Police under section 39Q, or

      • (iii)

        a person who obtained the prohibited drug from a person specified in subparagraph (i) or (ii) who is lawfully supplying the substance (the lawful supplier) to another person (the recipient) if—

        • (A)

          the person is employed or engaged by the lawful supplier to deliver or transport the prohibited drug to the recipient, and

        • (B)

          the possession or supply is only in connection with delivering or transporting the prohibited drug to the recipient, or

      • (iv)

        a police officer to a person authorised to have possession of the prohibited drug under the Medicines, Poisons and Therapeutic Goods Act 2022, including under a DMT authority under that Act,

    • (b)

      the taking part by any other person in the supply of a prohibited drug by a person to whom paragraph (a) applies.

    [18]Section 25A Offence of supplying prohibited drugs on an ongoing basis

    Omit section 25A(9). Insert instead—

    (9)

    Nothing in this section renders unlawful the supply of a prohibited drug by a person authorised under the Medicines, Poisons and Therapeutic Goods Act 2022, including under a DMT authority under that Act, to supply the prohibited drug.

    [19]Section 36ZE Substances to which this Part does not apply

    Omit section 36ZE(1)(c). Insert instead—

  • (c)

    a Schedule 2, 3 or 4 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 that is not a prohibited drug or prohibited scheduled substance,

  • (c1)

    a prohibited scheduled substance,

  • [20]Section 39A Application of Part

    Omit section 39A(1)(c). Insert instead—

  • (c)

    a prohibited scheduled substance,

  • [21]Section 40 Effect of certain representations

    Omit section 40(1A). Insert instead—

    (1A)

    A substance that is not a prohibited scheduled substance represented for the purposes of supply, whether verbally, in writing or by conduct, as being a prohibited scheduled substance or particular prohibited scheduled substance is, for the purposes of this Act and the regulations, taken to be a prohibited scheduled substance or the particular prohibited scheduled substance.

    [22]Sections 41 and 41A

    Omit the sections.

    sch 4: Am 2024 No 3, Sch 8; 2025 No 62, Sch 12[2] [3].

    Schedule 5Amendment of other legislation5.1Children and Young Persons (Care and Protection) Act 1998 No 157Section 175 Special medical treatment

    Omit section 175(5), definition of special medical treatment, paragraph (c1), including the note.

    Insert instead—

  • (c1)

    any medical treatment that involves the administration of a Schedule 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 over a period or periods totalling more than 10 days in any period of 30 days, or

  • 5.2Children (Detention Centres) Regulation 2015Clause 3 Definitions

    Omit clause 3(1), definition of drug, paragraph (b). Insert instead—

  • (b)

    a Schedule 2, 3 or 4 substance or prohibited scheduled substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022, or

  • 5.3Community Gaming Regulation 2020Clause 41 Prohibited prizes

    Omit clause 41(1)(c). Insert instead—

  • (c)

    a prize involving the administration to a person of scheduled substances or therapeutic goods that are regulated under regulations under the Medicines, Poisons and Therapeutic Goods Act 2022, section 54,

  • 5.4Confiscation of Proceeds of Crime Act 1989 No 90Section 7 Meaning of “serious offence” and “serious drug offence”

    Omit the definition of serious offence, paragraph (b). Insert instead—

  • (b)

    the offence of supplying a Schedule 4D substance under the Drug Misuse and Trafficking Act 1985, section 18B that arises under that Act, section 18C, or

  • 5.5Crimes Act 1900 No 40[1]Section 25C Supply of drugs causing death

    Omit section 25C(3). Insert instead—

    (3)

    A person does not commit an offence under this section for supplying a prohibited drug if the person is authorised under the Medicines, Poisons and Therapeutic Goods Act 2022 to supply the prohibited drug.

    [2]Section 193A Definitions

    Omit the definition of serious offence, paragraph (b). Insert instead—

  • (b)

    the offence of supplying a Schedule 4D substance under the Drug Misuse and Trafficking Act 1985, section 18B that arises under that Act, section 18C, or

  • [3]Section 428A Definitions

    Omit the definition of drug. Insert instead—

    drug means—

    • (a)

      a prohibited drug or prohibited scheduled substance within the meaning of the Drug Misuse and Trafficking Act 1985, and

    • (b)

      a Schedule 2, 3, 4, 5, 6, 7 or 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 that is not a prohibited drug or prohibited scheduled substance.

    5.6Crimes (Administration of Sentences) Act 1999 No 93[1]Section 236E Definitions

    Omit section 236E(1), definition of steroid. Insert instead—

    steroid means an anabolic or androgenic steroidal agent that is a Schedule 4 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022.

    [2]Section 253C Trafficking

    Omit “any poison listed in Appendix D of Schedule Four, or in Schedule Eight, of the Poisons List in force under the Poisons and Therapeutic Goods Act 1966” from section 253C(2).

    Insert instead “a Schedule 4D or 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022”.

    [3]Section 253C(3)

    Omit “Section 40 of the Poisons and Therapeutic Goods Act 1966”.

    Insert instead “The Medicines, Poisons and Therapeutic Goods Act 2022, section 125”.

    5.7Crimes (Administration of Sentences) Regulation 2014Clause 3 Interpretation

    Omit clause 3(3)(a) and (b). Insert instead—

  • (a)

    a Schedule 2, 3, 4 or 8 substance with the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022,

  • (b)

    a derivative of—

    • (i)

      a prohibited drug, prohibited plant or prohibited scheduled substance within the meaning of the Drug Misuse and Trafficking Act 1985, or

    • (ii)

      a substance referred to in paragraph (a),

  • 5.8Criminal Procedure Regulation 2017[1]Clause 24 Offences for which briefs of evidence not required

    Insert after section 24(e)—

  • (e1)

    proceedings for an offence under the Drug Misuse and Trafficking Act 1985, section 18B(2) in relation to possession of a Schedule 4D substance,

  • [2]Clause 24(f)

    Omit “section 16 (1) of the Poisons and Therapeutic Goods Act 1966”.

    Insert instead “the Medicines, Poisons and Therapeutic Goods Act 2022, Part 2.2–2.5”.

    5.9Drug Misuse and Trafficking Regulation 2021Section 5 Sales and storage of Schedule 1 precursors—the Act, s 45(2A)

    Omit “Poisons and Therapeutic Goods Act 1966” from section 5(7), definition of relevant therapeutic goods laws, paragraph (a).

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    5.10Electronic Transactions Regulation 2017Clauses 4(e) and 7(e)

    Omit the paragraphs.

    5.11Fair Trading Act 1987 No 68Schedule 1 Paramount legislation

    Omit “Poisons and Therapeutic Goods Act 1966”.

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    5.12Firearms Regulation 2017Clauses 5(1)(b), (2)(b) and (3)(b) and 42(1)(b), (2)(b) and (3)(b)

    Omit “prescribed restricted substance within the meaning of the Poisons and Therapeutic Goods Regulation 2008” wherever occurring.

    Insert instead “prohibited scheduled substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022”.

    5.13Government Information (Public Access) Regulation 2018Schedule 3 Agencies declared to be part of other agencies

    Omit the matter relating to the Medical Committee constituted under the Poisons and Therapeutic Goods Act 1966.

    Insert in appropriate order—

    Clinical Advisory Committee constituted under the Medicines, Poisons and Therapeutic Goods Act 2022

    Ministry of Health

    Regulatory Advisory Committee constituted under the Medicines, Poisons and Therapeutic Goods Act 2022

    Ministry of Health

    5.14Guardianship Regulation 2016[1]Clause 3 Definitions

    Omit clause 3(1), definition of restricted substance.

    Insert in alphabetical order—

    Schedule 4 substance has the same meaning as in the Medicines, Poisons and Therapeutic Goods Act 2022.

    [2]Clause 10 Major medical treatment

    Omit “restricted substance” from clause 10(1)(e). Insert instead “Schedule 4 substance”.

    [3]Clause 14 Experimental special medical treatment to which Tribunal may consent

    Omit “restricted substances” wherever occurring in clause 14(a).

    Insert instead “Schedule 4 substances”.

    5.15Health Administration Act 1982 No 135Section 23A Exchange of information between health officials

    Omit “Poisons and Therapeutic Goods Act 1966” from section 23A(4), definition of health official, paragraph (d).

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    5.16Health Care Complaints Act 1993 No 105Section 25 Notification of certain complaints to Health Secretary

    Omit the matter relating to the Poisons and Therapeutic Goods Act 1966 from section 25(1).

    Insert in appropriate order—

  • Medicines, Poisons and Therapeutic Goods Act 2022

  • 5.17Health Practitioner Regulation (Adoption of National Law) Act 2009 No 86[1]Schedule 1 Modification of Health Practitioner Regulation National Law

    Omit Schedule 1[13], section 138(1), definition of drug related offence, paragraph (b).

    Insert instead—

  • (b)

    the Medicines, Poisons and Therapeutic Goods Act 2022 or the repealed Poisons and Therapeutic Goods Act 1966 or regulations under either Act.

  • [2]Schedule 1[25], Schedule 5F, clause 1, definition of “pharmacy business”

    Omit “any substance specified in the Poisons List proclaimed under section 8 of the Poisons and Therapeutic Goods Act 1966”.

    Insert instead “a scheduled substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022”.

    5.18Health Practitioner Regulation (New South Wales) Regulation 2016[1]Schedule 5 Equipment and publications required for pharmacy premises

    Omit the following from clause 2—

    the Poisons and Therapeutic Goods Act 1966 and the regulations under that Act

    the Poisons List proclaimed under section 8 of the Poisons and Therapeutic Goods Act 1966 or the latest edition, and all published amendments or supplements to that edition, of the Guide to the New South Wales Medicines and Poisons Schedules published by the Pharmacy Guild of Australia (New South Wales Branch)

    Insert instead—

    the Medicines, Poisons and Therapeutic Goods Act 2022 and the regulations under that Act

    the NSW Poisons Schedules within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 or the latest edition, and all published amendments or supplements to that edition, of the Guide to the New South Wales Medicines and Poisons Schedules published by the Pharmacy Guild of Australia (New South Wales Branch)

    [2]Schedule 6 Publications required for professional services room premises

    Omit the following—

    the Poisons and Therapeutic Goods Act 1966 and the regulations under that Act

    the Poisons List proclaimed under section 8 of the Poisons and Therapeutic Goods Act 1966 or the latest edition, and all published amendments or supplements to that edition, of the Guide to the New South Wales Medicines and Poisons Schedules published by the Pharmacy Guild of Australia (New South Wales Branch)

    Insert instead—

    the Medicines, Poisons and Therapeutic Goods Act 2022 and the regulations under that Act

    the NSW Poisons Schedules within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 or the latest edition, and all published amendments or supplements to that edition, of the Guide to the New South Wales Medicines and Poisons Schedules published by the Pharmacy Guild of Australia (New South Wales Branch)

    5.19Health Professionals (Special Events Exemption) Act 1997 No 90[1]Section 3 Definitions

    Omit the definitions of drug of addiction, Poisons List, restricted substance and supply.

    Insert in alphabetical order—

    Schedule 4 substance has the same meaning as in the Medicines, Poisons and Therapeutic Goods Act 2022.

    Schedule 8 substance has the same meaning as in the Medicines, Poisons and Therapeutic Goods Act 2022.

    supply has the same meaning as in the Medicines, Poisons and Therapeutic Goods Act 2022.

    [2]Sections 9(4), 10(2)(d) and 11(1)–(3)

    Omit “Poisons and Therapeutic Goods Act 1966” wherever occurring.

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    [3]Section 10(1) and (2)(a) and (b) and 11(3)(a)

    Omit “restricted substance or drug of addiction” wherever occurring.

    Insert instead “Schedule 4 substance or Schedule 8 substance”.

    5.20Law Enforcement (Powers and Responsibilities) Act 2002 No 103[1]Section 21 Power to search persons and seize and detain things without warrant

    Omit section 21(1)(d). Insert instead—

  • (d)

    the person has in the person’s possession or under the person’s control—

    • (i)

      a prohibited plant or prohibited drug in contravention of the Drug Misuse and Trafficking Act 1985, or

    • (ii)

      a Schedule 4D substance, within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022, in contravention of that Act.

  • [2]Section 46A Searchable offences

    Insert “repealed” after “an offence under the” in section 46A(2), definition of narcotics offence, paragraph (a).

    [3]Section 46A(2), definition of “narcotics offence”

    Insert after paragraph (a)—

  • (a1)

    an offence under the Medicines, Poisons and Therapeutic Goods Act 2022, or a regulation made under that Act, that is committed in respect of a Schedule 4D or 8 substance within the meaning of that Act, or

  • [4]Schedule 2 Search warrants under other Acts

    Omit “Poisons and Therapeutic Goods Act 1966, section 43A”.

    Insert in alphabetical order—

    Medicines, Poisons and Therapeutic Goods Act 2022, section 100

    5.21Mental Health Act 2007 No 8Section 81 Transport of persons to and from mental health facilities and other health facilities

    Omit “Poisons and Therapeutic Goods Act 1966” from section 81(3), note.

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    5.22Police Act 1990 No 47Section 211AA Testing of officers for steroids

    Omit section 211AA(4), definition of steroid. Insert instead—

    steroid means an anabolic or androgenic steroidal agent that is a Schedule 4 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022.

    5.23Police Regulation 2015Clause 77 Definitions

    Omit the definition of steroid. Insert instead—

    steroid has the same meaning as in the Act, section 211AA.

    5.24Poppy Industry Act 2016 No 37[1]Section 4 Definitions

    Omit “Poisons and Therapeutic Goods Act 1966” from section 4(1), definition of manufacturing, export or research licence, paragraph (c).

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    [2]Section 5 Fit and proper person

    Omit “Poisons and Therapeutic Goods Act 1966 or regulations under that Act” from section 5(5)(c)(ii).

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022 or the repealed Poisons and Therapeutic Goods Act 1966 or regulations under either Act”.

    5.25Poppy Industry Regulation 2016[1]Clause 8 Checks and requirements for person employed or engaged

    Insert “repealed” after “against the” in clause 8(f)(iii).

    [2]Clause 8(f)(iiia)

    Insert after clause 8(f)(iii)—

  • (iiia)

    an offence against the Medicines, Poisons and Therapeutic Goods Act 2022 or regulations under that Act or against a corresponding law of another jurisdiction,

  • 5.26Prevention of Cruelty to Animals Act 1979 No 200Section 15 Poisons not to be administered to animals

    Omit section 15(1)(a). Insert instead—

  • (a)

    a scheduled substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 or a substance including a scheduled substance, or

  • 5.27Public Health (Tobacco) Act 2008 No 94[1A]Sections 21A(8)(a), 40(6)(a) and 50O(5)

    Omit “inspector under the Poisons and Therapeutic Goods Act 1966” wherever occurring.

    Insert instead “authorised officer under the Medicines, Poisons and Therapeutic Goods Act 2022”.

    [1]Section 22 Sale of tobacco and non-tobacco smoking products to minors

    Omit “Poisons and Therapeutic Goods Act 1966” from section 22(2A), note.

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    [2]Section 22(4), definition of “authorised product”, paragraph (b)

    Omit the paragraph. Insert instead—

  • (b)

    authorised under the Medicines, Poisons and Therapeutic Goods Act 2022 to be supplied.

  • [3]Schedule 2 Dictionary

    Omit “Poisons and Therapeutic Goods Act 1966, Part 3A” from the definition of illicit vaping goods.

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022, Chapter 3A”.

    5.28Road Transport Act 2013 No 18Schedule 3 Testing for alcohol and drug use

    Omit “Poisons and Therapeutic Goods Act 1966” from clause 1(1), definition of analyst, paragraph (b).

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    5.29Security Industry Regulation 2016Clause 15 Offences and civil penalties that disqualify applicants

    Omit “prescribed restricted substance within the meaning of the Poisons and Therapeutic Goods Regulation 2008” from clause 15(1)(b).

    Insert instead “Schedule 4D substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022”.

    5.30Stock Medicines Act 1989 No 182[1]Section 3 Definitions

    Omit “Poisons and Therapeutic Goods Act 1966 to supply a restricted substance” from section 3(1), definition of prescribe, paragraph (b).

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022 to supply a scheduled substance”.

    [2]Section 6

    Omit the section. Insert instead—

    6Activities authorised under Medicines, Poisons and Therapeutic Goods Act 2022

    A person does not commit an offence against this Act if the act or omission that would, but for this section, constitute the offence is authorised to be done or omitted to be done under the Medicines, Poisons and Therapeutic Goods Act 2022.

    [3]Section 39D Instructions to be provided by veterinary practitioners

    Omit section 39D(1)(c). Insert instead—

  • (c)

    prescribes or supplies a Schedule 2, 3, 4 or 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 for use on stock of a major food producing species, or uses a Schedule 2, 3, 4 or 8 substance on the stock.

  • [4]Section 39E Records to be kept by veterinary practitioners

    Omit section 39E(1)(c). Insert instead—

  • (c)

    the prescription or supply of a registered stock medicine that is a Schedule 2, 3, 4 or 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022 for use on stock of a major food producing species and the use by the veterinary practitioner on the stock.

  • 5.31Stock Medicines Regulation 2019Clause 7 Advertising etc

    Omit clause 7(1). Insert instead—

    This clause applies to a stock medicine that is a Schedule 3, 4 or 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022.

    5.32

    (Repealed)

    5.33Veterinary Practice Act 2003 No 87[1]Section 4 Definitions

    Insert in alphabetical order in section 4(1)—

    relevant law means the following—

    • (a)

      the Prevention of Cruelty to Animals Act 1979,

    • (b)

      the Biosecurity Act 2015,

    • (c)

      the repealed Poisons and Therapeutic Goods Act 1966,

    • (d)

      the Medicines, Poisons and Therapeutic Goods Act 2022,

    • (e)

      a relevant law within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022,

    • (f)

      the Export Control Act 2020 of the Commonwealth.

    [2]Section 18 Refusal of registration

    Omit section 18(b)(i). Insert instead—

  • (i)

    an offence under this Act or the regulations,

  • (ia)

    an offence under a relevant law or regulations under a relevant law,

  • [3]Section 19 Conditions of registration

    Omit “poisons and therapeutic substances” from section 19(4)(b)(ii).

    Insert instead “scheduled substances within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022”.

    [4]Section 27 Removal of person’s name from Register

    Omit section 27(2)(c)(i). Insert instead—

  • (i)

    an offence under this Act or the regulations,

  • (ia)

    an offence under a relevant law or regulations under a relevant law,

  • [5]Section 33 Annual return to be submitted

    Omit section 33(1)(a)(i). Insert instead—

  • (i)

    an offence under this Act or the regulations,

  • (ia)

    an offence under a relevant law or regulations under a relevant law,

  • 5.34Veterinary Practice Regulation 2013[1]Clause 4 Restricted acts of veterinary science

    Omit “specified in Schedule Four or Schedule Eight to the Poisons List proclaimed under the Poisons and Therapeutic Goods Act 1966” from clause 4(3), definition of anaesthetic agent.

    Insert instead “a Schedule 4 or 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022.

    [2]Schedule 2 Veterinary practitioners code of professional conduct

    Omit “restricted substances” from clause 20, heading.

    Insert instead “Schedule 4 or 8 substances”.

    [3]Schedule 2, clause 20(1)

    Omit “restricted”. Insert instead “Schedule 4 or 8”.

    [4]Schedule 2, clause 20(2)

    Omit “restricted substance medications”.

    Insert instead “Schedule 4 or 8 substances”.

    [5]Schedule 2, clause 20(3)

    Omit the subclause. Insert instead—

    (3)

    In this clause—

    Schedule 4 or 8 substance means a Schedule 4 or 8 substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022.

    5.35Voluntary Assisted Dying Act 2022 No 17[1]Section 14, heading

    Omit “Poisons and Therapeutic Goods Act 1966”.

    Insert instead “Medicine, Poisons and Therapeutic Goods Act 2022”.

    [2]Section 14

    Omit “Poisons and Therapeutic Goods Act 1966”.

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    [3]Section 74 Prescription for substance

    Omit “Poisons and Therapeutic Goods Act 1966” from Note 1, paragraph (a) and Note 2.

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    [4]Sections 77(1), 80(4) and 82(7)

    Omit “Poisons and Therapeutic Goods Act 1966” wherever occurring.

    Insert instead “Medicines, Poisons and Therapeutic Goods Act 2022”.

    [5]Section 128

    Omit the section. Insert instead—

    128Application of Medicines, Poisons and Therapeutic Goods Act 2022(1)

    The Medicines, Poisons and Therapeutic Goods Act 2022, Chapters 5 and 6 and Parts 7.2 and 7.3 (the applied provisions) apply, for the purposes of the enforcement of this Act, with—

    • (a)

      the modifications prescribed by the regulations, and

    • (b)

      necessary modifications.

    (2)

    A definition in the Medicines, Poisons and Therapeutic Goods Act 2022 of a term used in the applied provisions also applies for the purposes of the application of the provisions under subsection (1).

    [6]Schedule 1 Dictionary

    Omit the definitions of medicine, prescription, Schedule 4 poison, Schedule 8 poison and supply.

    Insert instead—

    medicine means—

    • (a)

      a scheduled substance within the meaning of the Medicines, Poisons and Therapeutic Goods Act 2022, and

    • (b)

      therapeutic goods, within the meaning of the Therapeutic Goods Act 1989 of the Commonwealth, that are not scheduled substances.

    NSW Poisons Schedule has the same meaning as in the Medicines, Poisons and Therapeutic Goods Act 2022.

    prescription, in relation to a voluntary assisted dying substance, means a prescription issued in accordance with the Medicines, Poisons and Therapeutic Goods Act 2022 for the voluntary assisted dying substance.

    Schedule 4 poison means a substance specified in Schedule 4 of the NSW Poisons Schedule.

    Schedule 8 poison means a substance specified in Schedule 8 of the NSW Poisons Schedule.

    supply, in relation to a voluntary assisted dying substance, includes the following—

    • (a)

      sell, dispense and distribute,

    • (b)

      supply, whether free of charge or otherwise, by way of sample or advertisement,

    • (c)

      supply, whether free of charge or otherwise, in the course of testing for safety or efficacy on persons or animals,

    • (d)

      agree or offer to sell or distribute,

    • (e)

      keep or have in possession for sale, dispensing or distribution,

    • (f)

      send, forward, deliver or receive for sale, dispensing or distribution,

    • (g)

      authorise, direct, cause, suffer, permit or attempt an act specified in paragraphs (a)–(f).

    5.36Weapons Prohibition Regulation 2017[1]Clause 5 Offences that disqualify applicants

    Omit “or prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985 or a prescribed restricted substance within the meaning of the Poisons and Therapeutic Goods Regulation 2008” from clause 5(1)(b).

    Insert instead “, prohibited drug or prohibited scheduled substance”.

    [2]Clause 5(2)(b) and (3)(b)

    Omit “or prohibited drug within the meaning of the Drug Misuse and Trafficking Act 1985, or a prescribed restricted substance within the meaning of the Poisons and Therapeutic Goods Regulation 2008,” wherever occurring.

    Insert instead “, prohibited drug or prohibited scheduled substance”.

    [3]Clause 5(4)

    Insert after clause 5(3)—

    (4)

    In this clause—

    prohibited drug and prohibited scheduled substance have the same meaning as in the Drug Misuse and Trafficking Act 1985.

    sch 5: Am 1987 No 15, sec 30C; 2024 No 22, Sch 5[3]; 2024 No 94, Sch 2[4]; 2025 No 51, Sch 2.2[2] [3].

    Historical notesTable of amending instruments

    Medicines, Poisons and Therapeutic Goods Act 2022 No 73. Assented to 28.11.2022. Date of commencement, except Sch 5.32: not in force; date of commencement of Sch 5.32, 17.2.2023, sec 2 and 2023 (46) LW 17.2.2023. This Act has been amended as follows—

    2023

    No 7

    Statute Law (Miscellaneous Provisions) Act 2023. Assented to 3.7.2023.

    Date of commencement, 14.7.2023, sec 2.

    No 35

    Statute Law (Miscellaneous Provisions) Act (No 2) 2023. Assented to 30.10.2023.

    Date of commencement of Sch 1.14, assent, sec 2(c).

    2024

    No 3

    Crime and Criminal Procedure Legislation Amendment Act 2024. Assented to 19.2.2024.

    Date of commencement, assent, sec 2.

    No 22

    Health Legislation Amendment (Miscellaneous) Act 2024. Assented to 27.5.2024.

    Date of commencement, assent, sec 2.

    No 94

    Public Health (Tobacco) Amendment Act 2024. Assented to 2.12.2024.

    Date of commencement, assent, sec 2.

    2025

    No 38

    Statute Law Amendment (Administrative Appeals Tribunal) Act 2025. Assented to 3.7.2025.

    Date of commencement, assent, sec 2.

    No 48

    Statute Law (Miscellaneous Provisions) Act 2025. Assented to 15.8.2025.

    Date of commencement of Sch 1.8, assent, sec 2(e).

    No 51

    Tobacco Legislation (Closure Orders) Amendment Act 2025. Assented to 15.9.2025.

    Date of commencement, 3.11.2025, sec 2 and 2025 (583) LW 31.10.2025.

    No 62

    Justice Legislation Amendment (Miscellaneous) Act (No 2) 2025. Assented to 28.10.2025.

    Date of commencement of Sch 12, assent, sec 2(c).

    This Act has been amended by sec 30C of the Interpretation Act 1987 No 15.

    Table of amendments

    Sec 18

    Am 2023 No 35, Sch 1.14.

    Sec 57

    Am 2025 No 48, Sch 1.8[1].

    Sec 69

    Am 2023 No 7, Sch 1.13[1] [2].

    Sec 76

    Am 2025 No 62, Sch 12[1].

    Chapter 3A

    Ins 2024 No 94, Sch 2[1].

    Chapter 3A, Part 1

    Ins 2024 No 94, Sch 2[1].

    Sec 85A

    Ins 2024 No 94, Sch 2[1].

    Chapter 3A, Part 2

    Ins 2024 No 94, Sch 2[1].

    Sec 85B

    Ins 2024 No 94, Sch 2[1].

    Sec 85C

    Ins 2024 No 94, Sch 2[1]. Am 2025 No 51, Sch 2.2[1].

    Sec 85D

    Ins 2024 No 94, Sch 2[1].

    Sec 88

    Am 2025 No 38, Sch 1.10.

    Sec 117

    Am 2024 No 22, Sch 5[1] [2].

    Sec 120

    Am 2024 No 94, Sch 2[2].

    Sch 2

    Am 2025 No 48, Sch 1.8[2].

    Sch 3

    Am 2024 No 94, Sch 2[3].

    Sch 4

    Am 2024 No 3, Sch 8; 2025 No 62, Sch 12[2] [3].

    Sch 5

    Am 1987 No 15, sec 30C; 2024 No 22, Sch 5[3]; 2024 No 94, Sch 2[4]; 2025 No 51, Sch 2.2[2] [3].

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