Australian Guidelines for the Registration of Drugs - Australian Government

Description

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.

Service type

Advisory Material

Advisory material provides advice and guidance in undertaking a business.

Act(s) name

Therapeutic Goods Act 1989 Australian Government

Regulation(s) name

Therapeutic Goods Regulations 1990 Australian Government

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.

Please use these contact details for help or more information:

Enquiries

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston, Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Toll Free: 1800 020 653
Email: info@tga.gov.au
Website: Therapeutic Goods Administration (Opens in new window)