Australian Guidelines for the Registration of Drugs - Australian Government


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.

Service type

Advisory Material

Advisory material provides advice and guidance in undertaking a business.

Eligibility requirements

Please consult the Contact Officer for more information regarding eligibility requirements.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

Administering agency

Department of Health and Aged Care

Therapeutic Goods Administration

Contact details

Contact Email, Phone and Address Details for this service in simple two column table format, header then data.