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New South Wales act
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Direct links to the current provisions in Medicines, Poisons and Therapeutic Goods Act 2022.
2 Commencement
This Act commences on a day or days to be appointed by proclamation.
3 Objects 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.
4 Definitions
(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.
5 Meaning 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.
6 Meaning 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.
7 Effect 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.
Part 2.1 Introduction
8 Application 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.
9 Authorisation 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).
10 Authorisation 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.
11 Regulations 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.
12 Regulations 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.
13 Application 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.
14 Offence—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.
15 Wholesale 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.
16 Wholesale 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.
17 Wholesale 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.
18 Wholesale 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.
19 Return 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.
20 Application 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.
21 Obtaining 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.
22 Obtaining 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.
23 Obtaining 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.
24 Obtaining 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.
25 Obtaining 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.
26 Obtaining 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.
27 Application 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.
28 Offence—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.
29 Non-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.
30 Non-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.
31 Non-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.
32 Non-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.
33 Non-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.
34 Non-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.
35 Application 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.
36 Offence—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.
37 Prescriptions 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.
38 Application 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.
39 Authorisation 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.
40 Offence—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.
41 Offence—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.
42 Offences—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.
43 Offence—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.
44 Offence—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.
45 Offence—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).
46 Offence—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.
47 Offence—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.
48 Defence 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.
49 Health 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.
50 Grounds 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.
51 Making 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.
52 Restriction 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).
53 Review 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.
54 Regulations 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.
55 Regulations 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.
Part 3.1 Introduction
56 Application 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.
Division 1 Granting of wholesaler licences and obtain licences
57 Wholesaler 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].
58 Grounds 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).
59 Application 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.
60 Conditions 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.
61 Variation 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.
62 Annual 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 2 Suspension or cancellation of wholesaler licences and obtain licences
63 Mandatory 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.
64 Discretionary 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.
65 Submissions 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.
66 Notice 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.
67 Application 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.
68 Granting 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.
69 Offence—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].
70 Application 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.
71 Conditions 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.
72 Variation 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.
73 Suspension 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.
74 Registration 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.
75 Offence—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.
76 Granting 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].
77 Application 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.
78 Duration 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.
79 Conditions 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.
80 Variation 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.
81 Suspension 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.
82 Application 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.
83 Information 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.
84 Investigation 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.
85 Fees 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.
Part 1 Preliminary
ch 3A, pt 1: Ins 2024 No 94, Sch 2[1].
85A Definitions
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].
85B Prohibition 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].
85C Prohibition 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.
Maximum penalty—330 penalty units.
(3) 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 100 times the commercial quantity, but less than 1,000 times the commercial quantity, of the kind of vaping goods.
Maximum penalty—5 years imprisonment or 8,400 penalty units, or both.
(4) 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 100 times the commercial quantity, but less than 1,000 times the commercial quantity, of the kind of vaping goods.
Maximum penalty—670 penalty units.
(5) 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 1,000 times the commercial quantity of the kind of vaping goods.
Maximum penalty—7 years imprisonment or 14,000 penalty units, or both.
(6) 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 1,000 times the commercial quantity of the kind of vaping goods.
Maximum penalty—1,170 penalty units.
(7) Subsections (1) and (2) do not apply in relation to the possession of the vaping goods by the person if—
(a) the vaping goods have been lawfully supplied to the person, and
(b) the vaping goods are for use by the person personally, and
(c) the quantity of the vaping goods is less than 5 times the commercial quantity of the kind of vaping goods.
(8) Subsections (1)–(6) do not apply if subsections (9) and (10) apply in relation to the possession of the vaping goods by the person.
(9) This subsection applies in relation to the possession 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.
(10) This subsection applies in relation to the possession of the vaping goods by the person if—
(a) the person—
(i) is 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) is 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, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, under this Act to supply one or more substances included in the NSW Poisons Schedules, Schedule 3,
(ii) the possession of the vaping goods 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 possess the vaping goods,
(ii) the possession of the vaping goods 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 possession of the vaping goods is in accordance with the determination.
s 85C: Ins 2024 No 94, Sch 2[1]. Am 2025 No 51, Sch 2.2[1].
85D Prohibition on possession of vaping goods—less than commercial quantities
(1) A person is guilty of an offence if—
(a) the person is a retailer in relation to retail premises in New South Wales, and
(b) the person possesses a quantity of a kind of vaping goods at the retail premises, and
(c) the quantity is less than the commercial quantity of the kind of vaping goods.
Maximum penalty—12 months imprisonment or 1,400 penalty units, or both.
(2) A person is guilty of a strict liability offence if—
(a) the person is a retailer in relation to retail premises in New South Wales, and
(b) the person possesses a quantity of a kind of vaping goods at the retail premises, and
(c) the quantity is less than the commercial quantity of the kind of vaping goods.
Maximum penalty—160 penalty units.
(3) Subsections (1) and (2) do not apply if subsections (4) and (5) apply in relation to the possession of the vaping goods by the person.
(4) This subsection applies in relation to the possession 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 possession of the vaping goods by the person if—
(a) both of the following apply—
(i) the person is a wholesaler, pharmacist, medical practitioner or nurse practitioner who is the holder of a licence, or is otherwise authorised, under this Act to supply one or more substances included in the NSW Poisons Schedules, Schedule 3,
(ii) the possession of the vaping goods is in accordance with the licence or authority, or
(b) both of the following apply—
(i) the person has been given a section 41RC consent to possess the vaping goods,
(ii) the possession of the vaping goods is in accordance with the consent, or
(c) 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 possession of the vaping goods is in accordance with the determination.
(6) Subsections (1) and (2) do not apply in relation to the possession of the vaping goods by the person if—
(a) the vaping goods are for use by the person personally, and
(b) the quantity of the vaping goods is not more than the permitted quantity of the kind of vaping goods.
(7) In this section—
permitted quantity, of a kind of vaping goods, has the same meaning as in the Commonwealth Therapeutic Goods Act, section 41QD(10).
retail premises means either of the following types of premises, whether or not the premises are used wholly or predominantly for the relevant purpose—
(a) premises from which goods or services are available for supply, or are supplied, to a consumer, or
(b) premises that are used in connection with the supply of goods or services to a consumer.
retailer, in relation to retail premises in New South Wales, means any of the following—
(a) an owner, lessee or occupier of the retail premises,
(b) a person conducting a business or undertaking at, or in connection or association with, the retail premises,
(c) a director, officer or agent of a person referred to in paragraph (a) or (b),
(d) a person performing work in any capacity, including an employee or a contractor, for, or on behalf of, a person referred to in paragraph (a), (b) or (c) at or in connection with the retail premises.
s 85D: Ins 2024 No 94, Sch 2[1].
86 Application of Commonwealth therapeutic goods laws
(1) The Commonwealth therapeutic goods laws, as in force from time to time and as modified by the regulations, apply as a law of New South Wales and are referred to in this Act as the applied provisions.
(2) The Commonwealth therapeutic goods laws apply as a law of New South Wales as if the laws extended to things done or omitted to be done—
(a) by a person who is not a corporation, and
(b) during trade or commerce within the limits of New South Wales.
(3) The regulations under this Act may modify the Commonwealth therapeutic goods laws for the purposes of this section.
(4) The Acts Interpretation Act 1901 and the Legislation Act 2003 of the Commonwealth, as in force from time to time, apply—
(a) as laws of New South Wales in relation to the interpretation of the applied provisions, and
(b) as if the applied provisions were an Act of the Commonwealth or regulations or orders under an Act of the Commonwealth, as the case requires.
(5) The Interpretation Act 1987 does not apply to the applied provisions.
87 Functions of Commonwealth Minister, Commonwealth Secretary and others
(1) The Commonwealth Minister has the same functions under the applied provisions as the Commonwealth Minister has under the Commonwealth therapeutic goods laws as the laws apply to the Commonwealth.
(2) The Commonwealth Secretary has the same functions under the applied provisions as the Commonwealth Secretary has under the Commonwealth therapeutic goods laws as the laws apply to the Commonwealth.
(3) Without limiting subsection (2), the Commonwealth Secretary has the function of including goods in the Australian Register of Therapeutic Goods kept under the applied provisions and is authorised to cancel the inclusion of goods in the Register in accordance with the applied provisions.
(4) An authorised person, authorised officer or official analyst appointed under the Commonwealth therapeutic goods laws has the same functions under the applied provisions as the person, officer or analyst has under the Commonwealth therapeutic goods laws as the laws apply to the Commonwealth.
(5) A delegation by the Commonwealth Minister or the Commonwealth Secretary under the Commonwealth therapeutic goods laws is taken to extend to, and have effect for the purposes of, the corresponding provision of the applied provisions.
(6) The appointment of a person to an office or position under a provision of the Commonwealth therapeutic goods laws is taken to extend to, and have effect for the purposes of, the applied provisions.
(7) In this section—
Commonwealth Minister means the Minister responsible for administering the Commonwealth therapeutic goods laws.
88 Application of Commonwealth administrative laws
(1) The Commonwealth administrative laws apply as a law of New South Wales to matters arising in relation to the applied provisions as if the applied provisions were laws of the Commonwealth and not a law of New South Wales.
(2) For the purposes of the law of New South Wales, a matter arising in relation to the applied provisions—
(a) is taken to be a matter arising in relation to the laws of the Commonwealth in the same way as if the applied provisions were laws of the Commonwealth, and
(b) is taken not to be a matter arising in relation to the law of New South Wales.
(3) Subsection (2) has effect for the purposes of the law of New South Wales except as provided for by the regulations.
(4) A provision of a Commonwealth administrative law applying because of this section purporting to confer jurisdiction on a federal court is taken not to have the effect.
(5) If a Commonwealth administrative law, which applies because of this section, confers a function on a Commonwealth officer or authority, the law also confers the same function on the officer or authority in relation to a matter arising in relation to the applied provisions.
(6) In exercising a function conferred by this section, the Commonwealth officer or authority must act as nearly as is practicable as the officer or authority would act in exercising the same function under the Commonwealth administrative law.
(7) A function conferred on a Commonwealth officer or authority because of this section must not be exercised by an officer or authority of New South Wales.
(8) In this section—
Commonwealth administrative laws means the following Acts of the Commonwealth and the regulations under the Acts—
(b) the Freedom of Information Act 1982,
(c) the Ombudsman Act 1976,
(d) the Privacy Act 1988.
s 88: Am 2025 No 38, Sch 1.10.
89 Application of Commonwealth criminal laws
(1) An offence against the applied provisions must be treated as if it were an offence against a law of the Commonwealth.
(2) The purposes for which an offence against the applied provisions must be treated as an offence against a law of the Commonwealth include, without limitation, the following—
(a) the investigation and prosecution of offences,
(b) the arrest, custody, bail, trial and conviction of offenders or persons charged with offences,
(c) proceedings relating to a matter referred to in paragraph (a) or (b),
(d) appeals and reviews relating to criminal proceedings and to proceedings relating to a matter referred to in paragraph (a) or (b),
(e) the sentencing, punishment and release of persons convicted of offences,
(f) fines, penalties and forfeitures,
(g) liability to make reparation in connection with offences,
(h) proceeds of crime,
(i) spent convictions.
(3) The Commonwealth laws relating to the matters specified in subsection (2) apply as a law of New South Wales in relation to an offence against the applied provisions as if the applied provisions were laws of the Commonwealth and not a law of New South Wales.
(4) For the purposes of the law of New South Wales, an offence against the applied provisions—
(a) is taken to be an offence against the laws of the Commonwealth, as if the applied provisions were laws of the Commonwealth, and
(b) is taken not to be an offence against the law of New South Wales.
(5) Subsection (4) has effect for the purposes of the law of New South Wales except as provided by the regulations.
90 Functions of Commonwealth officers and authorities relating to offences
(1) If a Commonwealth law, which applies because of section 89, confers a function in relation to an offence against the Commonwealth therapeutic goods laws on a Commonwealth officer or authority, the law also confers the same function on the officer or authority in relation to an offence against the corresponding provision of the applied provisions.
(2) In exercising a function conferred by this section, the Commonwealth officer or authority must act as nearly as practicable as the officer or authority would act in exercising the same function in relation to an offence against the corresponding provision of the Commonwealth therapeutic goods laws.
91 No double jeopardy for offences against applied provisions
An offender is not liable to be punished for an offence against the applied provisions for an act or omission if—
(a) the act or omission is an offence against both the applied provisions and the Commonwealth therapeutic goods laws, and
(b) the offender has been punished for the offence under the Commonwealth therapeutic goods laws.
92 Commonwealth may keep fees paid to Commonwealth Secretary
The Commonwealth may keep fees paid to, or recovered by, the Commonwealth Secretary for the exercise of functions conferred on the Commonwealth Secretary by the applied provisions.
Part 5.1 Information gathering
93 Application of Part
A reference in this Part to an authorised officer does not include a police officer.
94 Powers to require information and records
(1) An authorised officer may, by written notice given to a person, require the person to provide the authorised officer with information or records, or both, that the authorised officer requires for ensuring compliance with this Act and the regulations, including compliance with the conditions of a licence, approval or DMT authority (referred to in this Chapter as compliance purposes).
(2) A notice must specify—
(a) the way in which the information or records must be provided, and
(b) a reasonable time by which the information or records must be provided.
(3) A notice may only require a person to provide existing records that are—
(a) in the person’s possession, or
(b) within the person’s power to obtain lawfully.
(4) The authorised officer to whom records are provided under this section may make copies of the records.
(5) Records must be provided in written form, unless the notice otherwise provides.
95 Power to require answers
(1) An authorised officer may require a person to answer questions in relation to a relevant matter if the authorised officer suspects on reasonable grounds that the person has knowledge of the relevant matter.
(2) An authorised officer may, by written notice given to a corporation, require the corporation to nominate, within the time specified in the notice, one or more of the following, who has relevant knowledge about the corporation’s activities, as the corporation’s representative for the purposes of answering questions under this section—
(a) a director of the corporation,
(b) an officer of the corporation,
(c) a contractor.
(3) Answers given by a person nominated by the corporation bind the corporation.
(4) An authorised officer may, by written notice, require a person to attend at a specified place and time to answer questions if attendance at the place is reasonably required for the questions to be properly put and answered.
(5) The place and time at which a person may be required to attend under subsection (4) must be a place and time nominated by the authorised officer that is reasonable in the circumstances.
(6) In this section—
relevant matter means a matter in relation to which information is reasonably required for compliance purposes.
96 Recording of evidence
(1) An authorised officer may arrange for questions and answers to questions given under this Part to be recorded if the authorised officer has informed the person who will be questioned that a record will be made.
(2) A record may be made using—
(a) audio or audio visual equipment, or
(b) another method determined by the authorised officer.
(3) A copy of the record must be provided by the authorised officer to the person who is questioned as soon as practicable after the copy is made.
(4) A record may be made under this section despite the provisions of another law.
97 Power to require name and address
An authorised officer may require a person who the authorised officer suspects on reasonable grounds to have committed, or to be committing, an offence against this Act or the regulations to state the person’s full name, date of birth and residential address.
98 Privilege against self-incrimination not affected
A requirement made under this Part does not affect the privilege against self-incrimination as it applies to an individual.
99 Powers to enter premises
(1) An authorised officer may enter premises at a reasonable time for compliance purposes.
(2) Entry to premises may be effected under this Act—
(a) with the use of reasonable force, and
(b) with or without the authority of a search warrant.
(3) This Part does not empower an authorised officer to enter a part of premises used only for residential purposes without—
(a) the permission of the occupier, or
(b) the authority of a search warrant.
100 Search warrants
(1) An authorised officer may apply to an issuing officer for the issue of a search warrant for premises if the authorised officer believes on reasonable grounds—
(a) a requirement imposed by or under this Act is being or has been contravened at the premises, or
(b) there is, in or on the premises, a matter or thing connected with an offence under this Act or the regulations.
(2) An issuing officer to whom an application is made may, if satisfied there are reasonable grounds for doing so, issue a search warrant authorising an authorised officer named in the warrant—
(a) to enter the premises, and
(b) to exercise a function of an authorised officer under this Chapter.
(3) The Law Enforcement (Powers and Responsibilities) Act 2002, Part 5, Division 4 applies to a search warrant issued under this section.
(4) In this section—
issuing officer means an authorised officer within the meaning of the Law Enforcement (Powers and Responsibilities) Act 2002.
101 Powers permitted to be exercised on premises
(1) An authorised officer may, at premises lawfully entered, do anything the authorised officer considers necessary to be done for compliance purposes, including the following—
(a) search the premises,
(b) examine and inspect a thing, including open and examine a receptacle, container or package,
(c) take and remove samples of a thing, including for analysis,
(d) make examinations, inquiries or tests the authorised officer considers necessary,
(e) take photographs or other recordings the authorised officer considers necessary,
(f) require records or other documents to be produced for inspection,
(g) examine, inspect and remove records or other documents,
(h) copy records or other documents,
(i) seize a thing if the authorised officer has reasonable grounds for believing—
(i) the thing is connected with an offence against this Act or the regulations, or
(ii) the owner of the thing cannot readily be identified or determined,
(j) move a seized thing from the place where the thing is seized or leave the thing at the place where the thing is seized and take reasonable action to restrict access to the thing,
(k) direct the occupier of the premises where a thing is seized to keep the thing at the premises or at another place under the control of the occupier,
(l) require a person holding or required to hold a wholesaler licence, obtain licence, approval, OTP registration or DMT authority to produce it for inspection,
(m) anything else authorised by or under this Act.
(2) The power to examine and inspect a thing includes a power to use reasonable force to break open or otherwise access a container or other thing being used, or suspected of being used, to hold or contain another thing.
(3) The power to seize a thing connected with an offence includes a power to seize—
(a) a thing for or with which the offence has been committed, and
(b) a thing providing evidence of the commission of the offence, and
(c) a thing used for the purposes of committing the offence.
(4) The power to do a thing under this section—
(a) includes a power to require or arrange for the thing to be done, and
(b) may be exercised without the consent of the owner of the thing.
(5) In this section, a reference to an offence includes a reference to an offence there are reasonable grounds for believing has been committed.
102 Power to require name and address
An authorised officer may, at premises lawfully entered, require a person who the authorised officer suspects on reasonable grounds to have committed, or to be committing, an offence against this Act or the regulations to state the person’s full name, date of birth and residential address.
103 Requiring assistance
(1) An authorised officer may require the owner or occupier of premises, or another person in or on premises, other than a public place, to provide the reasonable assistance the authorised officer specifies for the purposes of exercising the authorised officer’s functions under this Part in relation to the premises.
(2) The requirement may be given—
(a) as a verbal direction to the person, or
(b) by written notice to the person.
104 Use of force
In exercising a power of entering or searching premises under this Part, or doing anything else on premises under this Act, an authorised officer must use no more force that is reasonably necessary to exercise the power.
105 Definition
In this Part—
seized thing means a thing seized by an authorised officer under Part 5.2.
106 Release of seized things
(1) A seized thing must be released at the end of the period of 6 months after the seizure (the return period) unless, before the end of the return period, the thing is forfeited to the State under this Part.
(2) The Health Secretary may, by written notice given to the apparent owner, extend the return period for a particular seized thing.
(3) A seized thing may be released—
(a) by or at the direction of—
(i) the authorised officer who seized the thing, or
(ii) the Health Secretary, and
(b) to the owner of the thing or the person who had possession, care, custody or control of the thing at the time the thing was seized.
(4) This section does not—
(a) require the release of a seized thing that was damaged or destroyed during analysis, or
(b) prevent a seized thing from being released before the end of the return period.
107 Forfeiture of seized things by order
(1) A seized thing is forfeited to the State if the Health Secretary makes an order under this section declaring the forfeiture of the thing.
(2) The Health Secretary may, by written order, declare a seized thing to be forfeited to the State if satisfied that—
(a) a person has been convicted of an offence in connection with the seized thing, or
(b) the owner of the seized thing cannot be found despite inquiries being made that are reasonable in the circumstances, or
(c) the seized thing cannot be returned to the owner for other reasons despite efforts being made that are reasonable in the circumstances, or
(d) the return of the seized thing would pose an unacceptable risk to the health or safety of a human or animal, whether or not identifiable, or
(e) other prescribed grounds.
(3) At least 21 days before making an order, the Health Secretary must give written notice to the apparent owner of a seized thing of the intention to declare the seized thing to be forfeited.
(4) The notice must specify a period within which the apparent owner may make submissions to the Health Secretary before the order is made.
(5) The Health Secretary must consider any submissions made within the specified period.
(6) The Health Secretary is not required to give notice to the apparent owner of a seized thing if—
(a) an authorised officer has given a written certificate that the authorised officer is unable to return the seized thing to the owner, or
(b) the Health Secretary is satisfied that—
(i) the owner of the seized thing cannot be found despite inquiries being made that are reasonable in the circumstances, or
(ii) the seized thing cannot be returned to the owner for other reasons despite efforts being made that are reasonable in the circumstances.
108 Forfeiture of seized things with consent
(1) The owner of a seized thing, or the person who had possession, care, custody or control of the thing at the time the thing was seized, may give written consent for the forfeiture of the thing.
(2) The seized thing is forfeited to the State when the written consent is given.
109 Order for expenses to be paid
(1) If a person from whom a seized thing has been seized is convicted of an offence in connection with the seized thing, the Supreme Court or Local Court may order the person to pay the Health Secretary an amount the Court considers appropriate to cover the reasonable costs of—
(a) seizing the thing, and
(b) dealing with the thing under this Part, and
(c) conducting an analysis for which the thing is submitted.
(2) Before making an order, the Court may require specified notice to be given to specified persons, as the Court considers appropriate.
110 Storage of and interference with seized things
(1) Subject to the directions of the Health Secretary, a seized thing may be kept or stored at—
(a) the premises at which the thing was seized, or
(b) another place the authorised officer who seized the thing considers appropriate.
(2) A person must not remove, alter or interfere with a seized thing without the approval of an authorised officer or the Health Secretary.
Maximum penalty for subsection (2)—Tier 5 penalty.
111 Disposal of forfeited things
A seized thing forfeited under this Part may be disposed of in a way directed by the Health Secretary, whether generally or in a particular circumstance or class of circumstances.
112 Offence—contravention of requirement made by authorised officer
(1) A person must not, without reasonable excuse, contravene a requirement made of the person by an authorised officer exercising a power under this Chapter.
Maximum penalty—Tier 4 penalty.
(2) A person is not guilty of an offence of failing to comply with a requirement to provide records or information or to answer a question unless the person was warned on the occasion that failure to comply is an offence.
113 Variation or revocation of notices
(1) The Health Secretary and an authorised officer may vary or revoke a notice given under this Chapter by a subsequent notice or notices.
(2) Without limiting subsection (1), a notice may be varied by extending the time for complying with the notice.
114 Destruction of things surrendered by enforcement agencies
(1) This section applies if a relevant enforcement agency—
(a) lawfully seizes a thing, and
(b) is not required under law to return the thing to the person from whom it was seized or to the owner.
(2) An authorised recipient may—
(a) agree to receive a thing that the relevant enforcement agency lawfully surrenders to the authorised recipient, and
(b) destroy, or authorise the destruction of, the thing if—
(i) a decision is made not to prosecute a person for an offence under this Act or another Act in connection with the thing, or
(ii) a decision is not made within 6 months of the surrender of the thing to prosecute a person for an offence under this Act or another Act in connection with the thing.
(3) Damages or other compensation is not payable to a person for the destruction of a thing in accordance with this section.
(4) In this section—
authorised recipient means the Health Secretary or a person authorised by the Health Secretary for the purposes of this section.
relevant enforcement agency means—
(a) the Australian Border Force, or
(b) another prescribed entity of an Australian jurisdiction with power to seize things that are or may be therapeutic goods.
Part 6.1 Compliance notices
115 Compliance notices
(1) The Health Secretary may give a person a written notice (a compliance notice) if the Health Secretary believes the person—
(a) is contravening—
(i) a provision of this Act or the regulations, or
(ii) a condition of a wholesaler licence, obtain licence, approval, OTP registration or DMT authority, or
(b) has contravened a provision or condition in circumstances making it likely the contravention will continue or be repeated.
(2) A compliance notice may require the person—
(a) to remedy the contravention, or
(b) to prevent a likely contravention from occurring, or
(c) to remedy the things or operations causing the contravention or likely contravention.
(3) A compliance notice must specify—
(a) the grounds on which the compliance notice is given, including the particular contravention on which the compliance notice is based, and
(b) the compliance period.
(4) A compliance notice may include directions about the measures to be taken to remedy the contravention or prevent the likely contravention.
(5) Before the end of the compliance period, the Health Secretary may, by written notice to the person, extend the compliance period for a compliance notice.
(6) A person must comply with the compliance notice within the compliance period.
Maximum penalty—Tier 4 penalty.
(7) The Health Secretary may vary or revoke a compliance notice.
(8) A compliance notice is not invalid only because of—
(a) a formal defect or irregularity in the compliance notice, unless the defect or irregularity causes or is likely to cause substantial injustice, or
(b) a failure to use the correct name of the person to whom the compliance notice is issued if the compliance notice—
(i) sufficiently identifies the person, and
(ii) is given to the person in accordance with this Act.
(9) In this section—
compliance period, for a compliance notice, means the period within which a person is required to comply with the compliance notice and includes the period as extended under subsection (5).
116 Review of compliance notices
(1) A person to whom a compliance notice is issued under section 115 may apply to the Health Secretary for a review of the decision to issue the compliance notice.
(2) An application must be—
(a) in an approved form, and
(b) made within the compliance period for the compliance notice under section 115.
(3) The Health Secretary may refuse to consider an application for review if the Health Secretary—
(a) has considered an application for review in relation to the same compliance notice within the previous 6 months, and
(b) is not satisfied there has been a material change in relevant circumstances.
(4) The Health Secretary must determine an application for review by—
(a) confirming the compliance notice, or
(b) varying the compliance notice, or
(c) revoking the compliance notice.
117 Maximum penalty for Tier 1, 2, 3, 4 and 5 offences
The following table sets out the maximum penalties for offences against this Act or the regulations for Tiers 1, 2, 3, 4 and 5—
| | Penalty for individuals | Penalty for corporations | | Tier | Penalty | Additional penalty for each day of continuing offence | Penalty | Additional penalty for each day of continuing offence | | Tier 1 | 2 years’ imprisonment or 400 penalty units, or both | 200 penalty units | 2,000 penalty units | 1,000 penalty units | | Tier 2 | 6 months’ imprisonment or 200 penalty units, or both | 100 penalty units | 1,000 penalty units | 500 penalty units | | Tier 3 | 100 penalty units | 50 penalty units | 500 penalty units | 250 penalty units | | Tier 4 | 50 penalty units | 25 penalty units | 250 penalty units | 125 penalty units | | Tier 5 | 20 penalty units | 10 penalty units | 100 penalty units | 50 penalty units |
s 117: Am 2024 No 22, Sch 5[1] [2].
118 Contraventions by corporations
(1) If a corporation contravenes a provision of this Act or the regulations, each person who is a director of the corporation or who is concerned in the management of the corporation is taken to have contravened the same provision if the person knowingly authorised or permitted the contravention.
(2) A person may be proceeded against and convicted under a provision as provided by subsection (1) whether or not the corporation has been proceeded against or convicted under the provision.
(3) This section does not affect the liability imposed on a corporation for an offence committed by the corporation under this Act or the regulations.
119 Continuing offences
(1) This section applies to a provision of this Act or the regulations requiring a person to do, or stop doing, something (a continuing requirement provision) regardless of whether—
(a) the requirement is imposed by a notice or in another way, or
(b) the person is required to do, or stop doing, something within a specified period.
(2) A person who is guilty of an offence because the person contravenes a continuing requirement provision—
(a) continues, until the requirement is complied with and despite the fact a specified period has expired or time has passed, to be liable to comply with the requirement, and
(b) is guilty of a continuing offence for each day the contravention continues.
(3) This section does not apply to an offence if the relevant provision of this Act or the regulations does not provide for a penalty for a continuing offence.
Note—
A provision that has a Tier 1–5 penalty includes a penalty for a continuing offence.
(4) This section does not apply to the extent that a requirement imposed on a person is revoked.
120 Proceedings for offences
(1) Proceedings for an offence under this Act or the regulations may be dealt with—
(a) summarily before the Local Court, or
(b) summarily before the Supreme Court in its summary jurisdiction.
(1A) Subsection (1) does not apply in relation to proceedings for an offence against section 85B(1), 85C(3) or 85C(5).
(2) Proceedings for an offence must be commenced not later than 2 years from when the offence was alleged to have been committed.
s 120: Am 2024 No 94, Sch 2[2].
121 Penalty notices
(1) An authorised officer may issue a penalty notice to a person if it appears to the officer the person has committed a penalty notice offence.
(2) A penalty notice offence is an offence against this Act or the regulations prescribed by the regulations as a penalty notice offence.
(3) The Fines Act 1996 applies to a penalty notice issued under this section.
Note—
The Fines Act 1996 provides that, if a person issued with a penalty notice does not wish to have the matter determined by a court, the person may pay the amount specified in the notice and is not liable to further proceedings for the alleged offence.
(4) The amount payable under a penalty notice issued under this section is the amount prescribed for the alleged offence by the regulations, not exceeding the maximum amount of penalty that could be imposed for the offence by a court.
(5) This section does not limit the operation of another provision of, or made under, this Act or another Act relating to proceedings that may be taken for offences.
122 Protection from personal liability
(1) A relevant person does not commit an offence against this Act or the regulations for an activity carried out in the exercise of functions under this Act or the regulations.
(2) A relevant person, or an individual acting under the direction of a relevant person, is not personally subject to civil liability for anything done or omitted to be done—
(a) in good faith, and
(b) for the purposes of exercising functions under this Act or the regulations.
(3) In this section—
civil liability includes an action, claim or demand.
relevant person means the following—
(a) the Health Secretary or a delegate of the Health Secretary,
(b) an authorised officer,
(c) a member of the Clinical Advisory Committee,
(d) a member of the Regulatory Advisory Committee.
123 Exclusion of civil liability of State and State authorities
(1) This section applies to civil proceedings for compensation brought against the State or an authority of the State.
(2) Compensation is not payable in civil proceedings to the extent the claim is based on alleged negligence, defamation or other breach of duty, including statutory duty, arising because of the exercise of, or the failure to exercise, functions under this Act or the regulations in good faith.
(3) In this section—
compensation includes damages and other forms of monetary compensation.
124 Certificates issued by Health Secretary
(1) A certificate purportedly issued by the Health Secretary or an authorised Health certifier stating a matter specified in subsection (2) was, or was not the case, at a specified time or during a specified period is—
(a) admissible in legal proceedings under this Act or another Act, and
(b) prima facie evidence of the matters stated.
(2) The following matters may be certified in a certificate issued under this section—
(a) a person had, or did not have, a particular authorisation,
(b) an authorisation was, or was not, subject to a particular condition, restriction, limitation or other requirement,
(c) a person was, or was not, an authorised officer or analyst,
(d) other prescribed matters relating to the enforcement or administration of this Act or the regulations.
(3) In this section—
authorisation includes an approval, exemption or other authority issued by the Health Secretary under this Act or the regulations.
authorised Health certifier means an employee of the Ministry of Health with written authorisation, whether generally or specifically, from the Health Secretary to issue a certificate under this section.
125 Certificates issued by analysts
(1) An analyst may give a certificate of the results of an analysis of a substance provided for analysis under this Act if the analyst—
(a) analysed the substance, or
(b) supervised or directed the analysis of the substance.
(2) A certificate purportedly issued by an analyst under this section about the results of an analysis is—
(a) admissible in legal proceedings under this Act or another Act, and
(b) prima facie evidence of the matters stated.
(3) A certificate purportedly issued by an interstate analyst under corresponding Australian legislation about the results of the analysis of a substance is—
(a) admissible in legal proceedings under this Act or another Act, and
(b) prima facie evidence of the matters stated.
(4) An analysis to which a certificate referred to in subsection (3) relates is taken to be an analysis of a substance provided under this Act.
(5) In this section—
interstate analyst means a person, however described, who analysed, or who supervised or directed the analysis of, a substance for the purposes of corresponding Australian legislation.
126 Presumptions
(1) This section applies to proceedings for a contravention of a provision of this Act or the regulations.
(2) Evidence that a substance or good is, for the purposes of supply or dispensing, represented as being or including a particular therapeutic good is prima facie evidence that the substance or good is or includes the particular therapeutic good.
(3) A substance or good is represented as being or including a particular therapeutic good for subsection (2) if —
(a) a name or description commonly used for the therapeutic good is also used for the substance or good, or
(b) the substance or good, or the container, is marked or labelled in the way that the therapeutic good or a thing including a therapeutic good, or the container, are required by the regulations to be marked or labelled, or
(c) the substance or good, or the container, is marked or labelled in another way to indicate it is, includes or may include the therapeutic good.
(4) In this section—
label includes to attach a tag, brand, mark or written statement to, or use a tag, brand, mark or written statement in connection with, a substance or good or a container or package containing the substance or good.
Part 7.1 Regulatory Advisory Committee and Clinical Advisory Committee
127 Regulatory Advisory Committee
(1) The Regulatory Advisory Committee is established by this Act.
(2) The function of the Committee is to advise the Health Secretary on matters referred to it by the Health Secretary relating to the following—
(a) the operation, administration or amendment of this Act, the regulations and the NSW Poisons Schedules, including proposals to make, alter or repeal the regulations,
(b) therapeutic goods or stock medicines,
(c) the scheduling of substances under the Commonwealth Therapeutic Goods Act.
(3) The Committee also has other functions conferred or imposed on it by or under this Act or another Act.
(4) The Committee must consist of not less than 9, and not more than 15, members appointed by the Health Secretary.
(5) The Health Secretary must appoint the following—
(a) a person nominated by the Commissioner of Police,
(b) a person nominated by SafeWork NSW,
(c) a person nominated by the Australian Medical Association,
(d) a person nominated by the New South Wales branch of the Pharmacy Guild of Australia,
(e) a person nominated by the New South Wales branch of the Pharmaceutical Society of Australia.
(6) The Health Secretary may appoint persons who the Health Secretary considers have qualifications or experience in the following areas—
(a) medical, dental, nursing and midwifery,
(b) veterinary practice,
(c) industrial use of scheduled substances, including in primary industry,
(d) pharmacology,
(e) toxicology,
(f) the medicines manufacturing and distribution industries,
(g) the development of medicines and the regulation of scheduled substances, including their registration as therapeutic goods under the Commonwealth Therapeutic Goods Act,
(h) assessing the risk of harm to humans, animals or the environment arising in connection with therapeutic goods,
(i) as a consumer of therapeutic goods.
(7) The Health Secretary may also appoint persons who the Health Secretary considers have prescribed qualifications or experience.
(8) The Health Secretary must appoint a member of the Committee as Chairperson.
(9) Schedule 1 contains provisions relating to the members and procedure of the Committee.
128 Clinical Advisory Committee
(1) The Clinical Advisory Committee is established by this Act.
(2) The Committee has the following functions—
(a) to make recommendations to the Health Secretary about applications for approvals and existing approvals,
(b) to advise the Health Secretary on other matters referred to the Committee by the Health Secretary,
(c) prescribed functions.
(3) The Committee must consist of at least 6 members appointed by the Health Secretary.
(4) Each member must be a medical practitioner, nurse practitioner or other prescribed health practitioner.
(5) The Health Secretary must appoint a member of the Committee as Chairperson.
(6) Schedule 1 contains provisions relating to the members and procedure of the Committee.
129 Information required from Health Care Complaints Commission and certain health practitioner bodies
(1) For the purposes of exercising its function under section 128(2)(a), the Clinical Advisory Committee may, by written notice to a relevant body, require a relevant body to provide information that the Committee reasonably requires to exercise the function.
(2) A relevant body must comply with a requirement given under this section.
(3) This section applies despite any provision of the Health Care Complaints Act 1993 or the Health Practitioner Regulation National Law (NSW).
(4) In this section—
relevant body means the following—
(a) Health Care Complaints Commission,
(b) Medical Council of New South Wales,
(c) Medical Board of Australia,
(d) Nursing and Midwifery Council of New South Wales,
(e) Nursing and Midwifery Board of Australia.
130 Subcommittees
(1) The Regulatory Advisory Committee and the Clinical Advisory Committee may—
(a) establish subcommittees for the purposes of assisting the Committee in the exercise of the Committee’s functions under this Act, and
(b) appoint as a member of a subcommittee a person the Committee considers to be qualified to be a member of the subcommittee.
(2) The members of a subcommittee do not need to be members of the Committee.
Sourced from legislation.nsw.gov.au, CC BY 4.0.
1 Name of Act
This Act is the Medicines, Poisons and Therapeutic Goods Act 2022.
2 Commencement
This Act commences on a day or days to be appointed by proclamation.
3 Objects 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.
4 Definitions
(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.
Who this affects
Why it matters (official purpose and then a practical test)
Official purpose (stated in the Act): to regulate activities involving scheduled substances and other prescribed therapeutic goods to protect public health and safety; to use the Commonwealth Poisons Standard as the classification basis; to complement Commonwealth therapeutic goods laws and provide admin/enforcement mechanisms (s 3).
How that purpose is implemented and the trade‑offs it creates:
Centralisation of decision‑making in the Health Secretary: the Act gives broad discretion to the Health Secretary to grant/deny/condition licences, approvals, OTP registrations and DMT authorities (ss 57–61, 68–73, 76–81). That concentrates regulatory choice in a single administrative office and speeds up one‑stop regulation, but means outcomes and compliance requirements will depend heavily on administrative policy and delegated regulations.
Heavy reliance on delegated instruments and Commonwealth material: the NSW Schedules adopt the Commonwealth Poisons Standard (s 6) and the Act makes many Commonwealth therapeutic goods provisions apply as NSW law (ss 85A–86). This reduces duplication of technical classification work but creates legal complexity where NSW modifies Commonwealth provisions (ss 6(3), 86(3), 149). It also creates practical dependency on Commonwealth decisions (e.g. inclusion in the Australian Register of Therapeutic Goods is directly relevant under s 85B(4)).
Compliance costs and enforcement: licence application fees, annual fees and possible fines (ss 59, 62, 85, 117) plus record‑keeping and inspection obligations (ss 55, 94–101) create compliance costs for private businesses and institutions. Penalties include imprisonment for serious breaches (see s 117 table and specific high penalties for vaping offences, ss 85B–85C). This raises the cost of doing business for wholesalers, pharmacies and retailers and may shift behaviour towards tighter internal control, substitution of products or exit for marginal operators.
Targeted authorisations and exemptions: the Act allows narrowly framed authorisations (e.g. for clinical trials s 39; OTP s 74; DMT authorities s 76; public health risk authorisations s 140). Those enable lawful uses that would otherwise be criminal, concentrating benefits for authorised researchers, public health entities and clinical trial sponsors while imposing monitoring obligations.
Market effects and private choice: the licensing and authorisation regime restricts who may lawfully supply or possess certain Schedules (Parts 2.2–2.6). This will limit entry for some suppliers and can raise compliance costs that are likely to be passed on in prices. Conversely, pharmacies and authorised providers retain established rights (ss 30–33) and may see reduced competition from unauthorised sellers (e.g. illicit vaping retail).
Enforcement reach and administrative risk: authorised officers have broad inspection and seizure powers (ss 99–101, 106–111), and the Health Secretary can issue restriction orders that revoke authorisations (s 49). These powers are designed to protect public health but create legal risk for businesses where administrative decisions can quickly alter operating rights. The Act provides internal review paths (e.g. reviews of compliance notices and restriction orders: ss 53, 116) but many operational details are left to regulations, producing short‑term uncertainty.
Who pays, who decides, what changes behaviour (short statements)
Implementation and compliance risks to watch
Key statutory hooks for quick reference: s 3 (objects), s 6 (NSW Poisons Schedules), ss 14 & 28 & 36 (core offence gates for wholesale/non‑wholesale supply and prescriptions), Part 3 (licences/approvals/OTP/DMT), ss 85B–85D (vaping goods), ss 94–106 (information, entry, search & seizure), ss 115–116 (compliance notices), s 117 (penalty tiers).
5 Meaning 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.
6 Meaning 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.
7 Effect 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.
Part 2.1 Introduction
8 Application 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.
9 Authorisation 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).
10 Authorisation 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.
11 Regulations 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.
12 Regulations 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 2.2 Wholesale supply
13 Application 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.
14 Offence—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.
15 Wholesale 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 d
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