Guidance

Guidance on how to apply to register a biosimilar medicine on the Australian Register of Therapeutic Goods (ARTG) and ongoing sponsor responsibilities.

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

Guidance for sponsors on the fees payable and timeframes for different types of prescription medicine applications.

Guidance to assist sponsors and manufacturers comply with Therapeutic Goods (Microbiological standards for medicines) (TGO 100) Order 2018.

Guidance on requirements relating to impurities in prescription medicines entered in the Australian Register of Therapeutic Goods (ARTG).

Guidance to assist sponsors to understand the process for submitting a priority registration application.

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 on bioavailability and/or bioequivalence aspects of medicines including information on biowaivers.

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

Guidance on criteria and supporting documentation required for a medicine to be eligible for provisional determination.

Guidance on the process for registering new medicines with new trade names that are 'clones' of currently registered prescription medicines

Guidance for sponsors and manufacturers of prescription medicines that contain, or are produced by, genetically modified organisms (GMOs).

This guidance helps sponsors understand the eligibility criteria and supporting documentation required for a medicine to be eligible for priority determination.

Guidance on provisional registration process for prescription medicines with provisional determination.

Guidance about how to make variations to Australian Register of Therapeutic Goods (ARTG) entries for prescription medicines.

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).

Guidance about the types of notifications and variations for chemically derived (non-biological) prescription medicines.

Guidance about application pathways and data requirements for new generic medicines, and variations to existing medicines.

Guidance on the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.

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

Guidance for sponsors about how to apply for orphan drug designation for a prescription medicine.

Guidance on submitting the CPD for prescription medicines.

Guidance about the process of applying for a priority determination, which is the first step of the priority review registration pathway.

Guidance on how to prepare your application for orphan drug designation so that it meets eligibility criteria and requirements.