Consultation: NSW Draft Medicines, Poisons and Therapeutic Goods Regulation

The NSW Ministry of Health is seeking feedback on the Exposure Draft Medicines, Poisons and Therapeutic Goods Regulation (Draft Regulation) and its Regulatory Impact Statement.  The AVA is preparing a submission and is inviting member feedback on it.

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. 

Further information can be found on the NSW Ministry of Health consultation website

What you can do
• Send your feedback to the AVA Senior Advocacy Officer Liz Gemes for consideration for inclusion in the formal AVA submission. Please send feedback to liz.gemes@ava.com.au by 12 November 2023.  
• Make your own submission directly via https://www.nsw.gov.au/have-your-say/medicines-poisons-and-therapeutic-goods, by Friday 22 December. Please note, the AVA will be providing further information and guidance in mid-November to support and encourage members to lodge their own submissions.