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 to be supplied with an application for registration of therapeutic goods in the Australian Register of Therapeutic Goods.

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

Service type

Code of Practice

A code of practice can be either a legal requirement or non-legal requirement. Legal codes of practice are defined as a result of legislation. Non-legal codes of practice are defined by industry regulators and bodies.

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

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: PO BOX 100
Woden, Australian Capital Territory 2606
Phone: 1800 020 653
Phone: 02 6232 8644
Email: info@tga.gov.au