Advertising medicines to consumers
Controls are placed on the advertising of therapeutic goods - medicines and medical devices to ensure advertisements are socially responsible, truthful, appropriate and not misleading.
The Therapeutic Goods Advertising Code <http://www.comlaw.gov.au> forms the basis for determining the acceptability of advertisements for therapeutic goods directed to consumers.
It is a requirement under the Therapeutic Goods Act 1989 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. 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 s22.5 of the Therapeutic Goods Act 1989 <http://www.tga.gov.au/legis/index.htm#acts>).
- Products containing schedule 3, 4 or 8 ingredients cannot be advertised to consumers unless the ingredients appear in Appendix H of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) <http://www.tga.gov.au/ndpsc/susdp.htm>. (refer Section 42DL(1)(f) of the Therapeutic Goods Act 1989 <http://www.tga.gov.au/legis/index.htm#acts>).
- 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 Therapeutic Goods Regulations <http://www.tga.gov.au/legis/index.htm#acts>).
If the advertisement is in a magazine or newspaper the approval number is required to appear in the advertisement. (refer s42C of the Therapeutic Goods Act 1989 <http://www.tga.gov.au/legis/index.htm#acts> and Regulations 5F-5Q of the Therapeutic Goods Regulations <http://www.tga.gov.au/legis/index.htm#acts>).
Applications for approval of complementary medicines appearing in specified media need to be submitted to:
Advertising Services
Complementary Healthcare Council
PO Box 104
Deakin West ACT 2600
Ph: 02 6260 4022
Fax: 02 6260 4122
Applications for approval of over-the-counter pharmaceutical medicines appearing in specified media and advertisements for all medicines appearing in radio or television need to be submitted to the Australian Self-Medication Industry.
Applications for approval of these advertisements need to be submitted to:
Advertising Services
Australian Self-Medication Industry
PO Box 764
North Sydney NSW 2059
Ph: 02 9955 7205
Fax: 02 9957 6204
Advertisements for all therapeutic goods must comply with the Therapeutic Goods Act 1989 , Part 2 of the Therapeutic Goods Regulations and the Therapeutic Goods Advertising Code.
Copies of the Therapeutic Goods Advertising Code are located on the ComLaw website <http://www.comlaw.gov.au>.
Further assistance regarding the regulatory requirements for advertising may be obtained from the Advertising and Export Section of the Therapeutic Goods Administration by calling 02 6232 8757 or by facsimile 02 6232 8659.