Legal and Regulatory Services is responsible for developing new regulations within the health portfolio. In addition, all regulations are subject to staged repeal every five years under the Subordinate Legislation Act 1989. Legal and Regulatory Services also develops regulatory impact statements required in accordance with that Act.

Draft Medicines, Poisons and Therapeutic Goods Regulation

The NSW Ministry of Health is seeking your feedback on the Exposure Draft Medicines, Poisons and Therapeutic Goods Regulation (Draft Regulation) and its Regulatory Impact Statement.

The Medicines, Poisons and Therapeutic Goods Act 2022 (the Act) passed Parliament in November 2022. On commencement, the Act will replace the current Poisons and Therapeutic Goods Act 1966 (PTGA) which is the primary legislative framework governing the control of medicines, poisons, and therapeutic goods in NSW.

The Draft Regulation will support the operation of the Act. Medicines, poisons (chemicals) and therapeutic goods are an essential part of people’s lives and our society. These substances bring many benefits to health and are necessary in many industries. However, the substances can also pose a risk to health and safety when used inappropriately.

Together, the Act and Draft Regulation set out who can manufacture, supply by wholesale, obtain, supply, prescribe, use, and administer these substances. The Draft Regulation also sets out specific obligations in relation to prescription requirements, on-the-spot fines, fees, when an approval or authority from the Health Secretary is required, labelling, disposal and destruction of these substances. The Act and the Draft Regulation seek to ensure that the framework regulating medicines, poisons and therapeutic goods is contemporary, robust, safe, and efficient.

The consultation period is open from 26 September 2023 to 22 December 2023. Submissions should include the reference DG23/5729 and must be received by 22 December 2023.

Submissions should be sent via email to or sent in hardcopy to:
Legal and Regulatory Services Branch
NSW Ministry of Health
Locked Mail Bag 2030
St Leonards NSW 1590

If you have any queries, please email the MPTG Project Team at

Current as at: Tuesday 26 September 2023
Contact page owner: Legal and Regulatory Services