Advertising medicines to consumers

8 April 2011

Controls are placed on the advertising of therapeutic goods (medicines and medical devices) to ensure advertisements are socially responsible, truthful, appropriate and not misleading.

Advertisements for all therapeutic goods must comply with the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and the Therapeutic Goods Advertising Code (the Code). The Code (forms the basis for determining the acceptability of advertisements for therapeutic goods directed to consumers.

Only non-prescription medicines - over the counter and non-prescription complementary medicines - can be advertised to consumers. Prescription medicines can only be advertised to health professionals.

It is a requirement under the the Act that therapeutic goods (unless exempt) be included in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. Once the goods are on the ARTG, the sponsor may begin to promote the product to consumers.

Some limitations on advertising to consumers

When advertising therapeutic goods, the sponsor needs to be mindful of the following:

  • Only those indications accepted for inclusion in the ARTG for the products may be advertised. (refer Section 22(5) of the Act)
  • Products containing ingredients specified in Schedules 3. 4 or 8 of the current Poisons Standard cannot be advertised to consumers unless in the case of Schedule 3 medicines the ingredients appear in Appendix H of the current Poisons Standard (refer Section 42DL(1)(f) of the Act)
  • Advertisements for medicines appearing on television or radio, newspapers, consumer magazines, billboards and cinema films need approval before publication.(refer Part 2 Division 2 of the Regulations

If the advertisement is in a magazine or newspaper, the approval number must appear in the advertisement. (refer Section 42C of the Act and regulations 5Jof the Regulations and subsection 6(4) of the Code)

Getting approval

Applications for approval of advertisements for complementary medicines appearing in specified media need to be submitted to:

Office of Advertising Compliance
Complementary Healthcare Council
PO Box 820
Mawson ACT 2607
Ph: 02 6260 4066
Fax: 02 6260 4122

Applications for approval of advertisements for over-the-counter medicines appearing in specified media, and advertisements for all medicines appearing on radio or television need to be submitted to the Australian Self-Medication Industry:

Advertising Services
Australian Self-Medication Industry
PO Box 764
North Sydney NSW 2059
Ph: 02 9955 7205
Fax: 02 9957 6204

For more information

More information is available from: Regulation of therapeutic goods advertising in Australia.

Further assistance about the regulatory requirements for advertising may be obtained from the TGA Recalls and Advertising Section:

Phone +61 2 6232 8757
Fax +61 2 6232 8426