Guidance

Provides guidance on the regulatory requirements for labels and other medicine presentation.

Guidance for hand sanitiser manufacturers, suppliers and advertisers about meeting their regulatory obligations.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 3.

Australian regulatory guidelines for over-the-counter medicines (ARGOM) Appendix 4.

Guidance for manufacturers of medical or surgical face masks and respirators on the standards and key performance aspects required for inclusion on the Australian Register of Therapeutic Goods (ARTG).

Guidance for data requirements for microorganisms used as active ingredients in listed or registered complementary medicines. These are generally referred to as probiotics or postbiotics.

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 for industry organisations applying to add a medicine to the Australian Register of Therapeutic Goods (ARTG).

An overview of the Data Protection Scheme for assessed listed medicines, and the criteria that must be met for information to be considered protected under the Scheme.

This guidance explains requirements for registering a non-prescription OTC medicine on the Australian Register of Therapeutic Goods (ARTG).

This guidance will help you understand our pharmacovigilance inspection program (PVIP).

Guidance on changing information in the ARTG for listed or assessed listed medicines.

Guidance for sponsors of COVID-19 IVDs about their ongoing obligations

Guidance to assist sponsors and manufacturers in preparing their documentation for applications for COVID-19 rapid antigen tests.

Guidance for sponsors and manufacturers about pathways for exporting a ventilator from Australia.

Guidance clarifying the interaction between our requirements and AHPRA advertising guidelines.

Guidance on the rules governing COVID-19 rapid antigen tests (RATs) advertising.

Guidance relating to the supply of in vitro diagnostic medical devices for the detection of COVID-19/SARS-CoV-2 infections.

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

Guidance on the format requirements for dossiers.

Guidance explaining types of variations, for registered medicines and biologicals, that can be submitted as notifications due to being very low risk.

Guidance about evidence required to substantiate the quality of the product, for over-the-counter (OTC) medicine registration applications.

Guidance on submitting an effective application to register an over-the-counter (OTC) medicine.

Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations.

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