Labelling of Medicines - Australian Government

Description

You will need to comply with these standards if you intend to package therapeutic goods or medicines for use within Australia. These standards include requirements for:
  • label size
  • font size
  • measurements of the product contained
  • product name
  • storage conditions
  • directions for use
  • further information as required.

You must submit your intended label to the administering agency before it is able to be placed on the market. Please consult the Contact Officer for more information and to ascertain the level of compliance 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

Therapeutic Goods Administration

Department of Health

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