Guidance

Guidance to help sponsors and manufacturers of medicines meet the Australian labelling requirements in TGO 91 and TGO 92.

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).

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).

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

Guidance to understand the quality requirements of Therapeutic Goods Order No. 101 - Standard for tablets, capsules and pills (TGO 101, the Order).

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

This guidance provides information about preparing Consumer Medicine Information (CMI) documents that comply with current regulations.

Guidance to help manufacturers and sponsors navigate packaging terms across the industry, to meet regulatory requirements.

Guidance explaining how to find out which statements (if any) are required by the RASML for a particular over-the-counter (OTC) or complementary medicine.

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

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

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

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

Guidance about the Annual Charge Exemption scheme waiver process.

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

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

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

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

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.