You may be required to comply with these guidelines if you intend to manufacture therapeutic goods or biologicals. These guidelines describe the information you must supply with an application for registration of therapeutic goods in the Australian Register of Therapeutic Goods.
The guidelines 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.
Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.
