New medicines, poisons and pest management regulatory framework
From 27 September 2021, the Medicines and Poisons Act 2019 (MPA) and Therapeutic Goods Act 2019 (TG Act (Qld)) and the supporting regulations, introduce a new legislative framework for medicines, poisons, pesticides, fumigants and prohibited substances (collectively known as regulated substances) in Queensland.
Access key legislation and documentation:
- Legislation, standards and extended practice authorities
- Fact sheets and supporting documents
- Key partners
Medicines and Poisons Act 2019
The Medicines and Poisons Act 2019 (MPA) repeals and replaces the Health Act 1937 and the Pest Management Act 2001 with a new regulatory framework to:
- modernise and streamline the regulation of medicines and poisons
- simplify existing licence requirements
- improve national uniformity
- introduce real-time prescription monitoring.
A key objective of the MPA is to ensure substances, including medicines, poisons, pesticides and fumigants are used safely and effectively and do not cause harm to human health. The MPA adopts the national classification system for medicines and poisons as specified in the current version of the Standard for the Uniform Scheduling of Medicines and Poisons (Poisons Standard). Medicines and poisons are scheduled in accordance with the National Scheduling Policy Framework for Medicines and Chemicals and the Therapeutic Goods Act 1989 (Cwlth).
Chemicals used for pest management activities are approved, registered or permitted for use as pesticides or fumigants by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Also, many pesticides and fumigants are scheduled poisons and listed in the Poisons Standard.
The MPA and supporting regulations cover activities that involve approved substances included in the schedules of the Poisons Standard and substances registered or permitted for use by the Australian Pesticides and Veterinary Medicines Authority.
The MPA is supported by three regulations:
- Medicines and Poisons (Medicines) Regulation 2021
- Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021
- Medicines and Poisons (Pest Management Activities) Regulation 2021
Therapeutic Goods Act 2019 (Qld)
The Therapeutic Goods Act 2019 (TG Act (Qld)) adopts the Therapeutic Goods Act 1989 (Cwlth) and the regulations, orders, permissions and manufacturing principles under the it as laws of Queensland. The TG Act (Qld) uses the defined term ‘Commonwealth Therapeutic Goods Laws’ to collectively refer to these legislative instruments.
The TG Act (Qld) ensures national regulatory controls apply consistently to Queensland-based manufacturers of therapeutic goods. The Commonwealth Act applies to corporations and entities that trade interstate or across national borders. While this applies to most Queensland manufacturers, adopting the Commonwealth Act as a law of Queensland means it also applies to non-corporate entities such as sole traders and partnerships that only trade within Queensland. As such, these manufacturers will be subject to the same Commonwealth requirements as all other manufacturers.
The TG Act (Qld) is supported by the Therapeutic Goods Regulation 2021 (Qld).