The Poisons Standard

Guidance providing an overview of listed medicines and assessed listed medicines pathways and legislative requirements.

This guidance explains the new regulatory requirements for medical devices containing medicinal, microbial, recombinant, or animal origin substances effective from 1 July 2024. It helps sponsors interpret the new classification rule, conformity assessment requirements and transition arrangements.

Guidance on the regulatory requirements for assessed listed medicines.

Guidance on when and how to provide Product Information to us.

Guidance on the evaluation process and information required for new registered complementary medicines.

This guidance will assist companies making announcements, to comply with their continuous disclosure obligations, without advertising therapeutic goods to the public.

Guidance for sponsors on the information required to establish quality for listed medicines.

This guidance explains parts 4 and 5 of the Code, which requires certain information to be prominently displayed or communicated in advertisements for therapeutic goods.

Guidance for the requirements applicable to medical devices containing poisons.

Guidance on whether medicines are evaluated as prescription medicines or complementary or over-the-counter (OTC) medicines.

This guidance provides for a nationally uniform approach to retail storage of Schedule 6 and Schedule 7 poisons.

Guidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.

Guidance on the application of the Therapeutic Goods (Vaping Goods - Possession and Supply) Determination 2024.

This guidance supports psychiatrists in understanding their regulatory requirements when prescribing MDMA and psilocybine from 1 July 2023.

Guidance on advertising services that involve therapeutic goods.

Guidance about how we define and regulate listed disinfectants, including how to submit a product application and the supporting data and other information required.

General Guidance on the regulation of listed medicines and registered complementary medicines (RCM) in Australia.

Guidance to help sponsors and manufacturers of therapeutic goods to understand and use the Poisons Standard to determine if any restrictions apply to their product.

Guidance on how to access and use the Permissible Ingredients Determination for the purposes of submitting applications for substances in listed and assessed listed medicines.

Guidance for sponsors on changing information in the Australian Register of Therapeutic Goods (ARTG) for registered complementary medicines.

Guidance on how the Poisons Standard is amended and the processes that underpin scheduling policy