Australian Guidelines for the Registration of Drugs - Australian Government


You may be required to comply with these guidelines if you intend to manufacture therapeutic goods or biologicals. These guidelines describe the information to be supplied 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.

Please consult the Contact Officer for more information and to ascertain the level of compliance (if any) that may be required.

Service type

Advisory Material

Advisory material provides advice and guidance in undertaking a business.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Regulations 1990 AG

Administering agency

Department of Health

Therapeutic Goods Administration

Contact details

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

Enquiries Officer

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Phone: 1800 020 653
Phone: 02 6232 8644