Prescription medicines collection

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

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

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

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

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

Guidance on providing adventitious agent safety information in applications for medicines containing, or manufactured using, materials of animal or human origin.

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

Australian recommendations and requirements

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

Guidance about the types of notifications and variations for biological medicines.