General Requirements for Labels for Medicines - Australian Government

Service summary

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; and
  • 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.

Administering agency

Department of Health
Therapeutic Goods Administration

Act(s) name

Therapeutic Goods Act 1989 (Australian Government)

Regulation(s) name

Therapeutic Goods Order No. 69 - General Requirements for Labels for Medicines 2001 (Australian Government)

Contact details

Enquiries Officer
Department of Health
Therapeutic Goods Administration


Operating address:
136 Narrabundah Lane
Symonston
Australian Capital Territory 2609
Mailing address:
PO Box 100
Woden
Australian Capital Territory 2606

Phone:

1800020653

Phone:

02 62328644
info@tga.gov.au

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