You may need to comply with these guidelines if you intend to manufacture therapeutic goods or biologicals. These guidelines:
- describe the information that must be supplied with an application for the registration of therapeutic goods in the Australian Register of Therapeutic Goods
- provide information on how to register a drug, and how to vary the registration of an existing substance.
You must include information specified in Common Technical Module 1: OTC Medicines with your over-the-counter medicines application.