Standard for Labels of Non-Prescription Medicines - Australian Government

Description

You may be required to comply with this standard if you intend to label non-prescription medicines. You have obligations to label medicines according to the requirements prescribed by the Therapeutic Goods Administration, and compliance with this code should achieve this aim.

The standard requires that label parts are described from a consumer's perspective, and that the parts are:

  • named to reflect what consumers do with them
  • shown in the order in which research suggests they are likely to be used
  • ordered independently of the regulatory requirements for what has to appear on the front/back of labels
  • important at the time of purchase and through the life of the product.

Please note that the Agency has advised that there are various codes for medicines, medical devices and chemicals which are amended on a regular basis.

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

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.

Other resources

Act(s) name

Therapeutic Goods Act 1989 AG

Regulation(s) name

Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2001 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

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
Phone: 02 6232 8644
Phone: 1800 020 653
Fax: 02 6203 1605
Email: info@tga.gov.au