General Requirements for Labels for Medicines - Australian Government

Description

This Order describes the national labelling requirements for all packaged medicines.

Medicines are defined as therapeutic goods that are represented to achieve their intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human or animal.

It excludes goods:

  • intended solely for use in animals
  • intended for use solely for experimental purposes in humans
  • that have not reached their final stage of manufacture
  • that are personal imports
  • that are medicinal gases
  • that are solely for export
  • made up or compounded in accordance with the individual prescription of a medical practitioner, dentist or veterinary surgeon by a pharmacist or by a person in the course of his or her employment by a pharmacist and under the actual personal supervision of that pharmacist
  • made up or compounded extemporaneously for a specific or individual case by a pharmacist in the lawful practice of his or her profession
  • supplied in the course of treating a patient or animal by a medical practitioner, dentist or veterinary surgeon in the lawful practice of his or her profession, other than professional starter packs
  • made up or compounded extemporaneously for a specific and individual case, in that person s presence, by a complementary healthcare practitioner in the lawful practice of his or her profession.

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. 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.

Enquiries 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: 1800 020 653
Phone: 02 6232 8644
Email: info@tga.gov.au