Guidance

Information to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.

Guidance on how to meet child-resistant packaging requirements in the Therapeutic Goods Order No. 95 - Child-resistant packaging requirements for medicines 2017 (TGO 95).

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.

Australian Regulatory Guidelines for Biologicals (ARGB). This guidance will help you understand how to classify your biological.

Guidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.

Guidance for new sponsors on how to supply, import, and export disinfectant products.

Guidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.

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