For any individuals or businesses involved in the supply, possession, storage, transport, disposal or licensing of medicines, poisons, pesticides, fumigants, and prohibited substances (collectively known as regulated substances), a new legislative framework is about to overhaul the status quo in Queensland.
From 27 September 2021, the regulations supporting the Medicines and Poisons Act 2019 and Therapeutic Goods Act 2019 have been approved to commence with those Acts at the Governor-in-Council meeting on 16 September 2021.
The new legislation comprises:
- Medicines and Poisons (Medicines) Regulation 2021
- Medicines and Poisons (Poisons and Prohibited Substances) Regulation 2021
- Medicines and Poisons (Pest Management Activities) Regulation 2021.
With the commencement of the new legislative scheme, the Health Act 1937 with the Health (Drugs and Poisons) Regulation 1996 (HDPR), and the Pest Management Act 2001 and the Pest Management Regulation 2003 will all be revoked.
The Medicines and Poisons Act 2019 and supporting regulations introduces a new legislative framework intended to modernise and streamline the medicines and poisons regulatory framework, making it easier for practitioners, industry and the community to understand and apply them in practice. The framework has also been adopted to provide greater assurance to the community that medicines, poisons, pest management activities and therapeutic goods are regulated by a framework that enhances public safety.
Importantly, the Therapeutic Goods Act 2019 (Qld) adopts the Commonwealth's Therapeutic Goods Act 1989 (Commonwealth Act) and regulations, orders and manufacturing principles as laws of Queensland. The new Queensland Act is intended to reduce regulatory burden and enables the application of national regulatory controls to Queensland-based manufacturers of therapeutic goods. Upon commencement, non-corporate entities in Queensland such as sole traders and partnerships trading only within Queensland, will be subject to the same Commonwealth requirements as all other manufacturers.
The Queensland Department of Health have advised that further information about the Medicines and Poisons Act 2019 and Therapeutic Goods Act 2019 and supporting regulations, and what this means for you, will be available on the Queensland Health website upon commencement.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.