Medicines, Poisons and Therapeutic Goods Regulation 2023

Client: NSW Ministry of Health


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 MPTGR will support the operation of the Act. 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 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 Regulation seek to ensure that the framework regulating medicines, poisons and therapeutic goods is contemporary, robust, safe, and efficient.

ACIL Allen was engaged by the NSW Ministry of Health to develop a RIS for the new MPTGR.

The RIS assesses the need for regulation and the impacts (both costs and benefits) of the proposed MPTGR.

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