Standard for Tablets and Capsules - Australian Government

Description

You must comply with this standard if you are involved in the manufacture of therapeutic or medicinal products that are sold in tablet or capsule form.

Please note that you are exempt from complying with this standard if you are only involved in the manufacture of either:

  • medicines intended solely for export from Australia
  • radio-pharmaceuticals (pharmaceutical products that contain radioactive substances).

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.

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Order No. 78 - Standard for Tablets and Capsules 2008 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.

Information Officer, Office of Manufacturing Quality

Therapeutic Goods Administration

Department of Health

Operating address: 136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address: Office of Manufacturing Quality, TGA, PO Box 100
Woden
Australian Capital Territory 2606
Phone: 02 6221 6881
Phone: 1800 446 443
Fax: 02 6232 8426
Email: gmp@tga.gov.au