Therapeutic goods advertising code: notice of amendments, July 2003

Amendments have been made the Therapeutic Goods Advertising Code. Updated copies of the Therapeutic Goods Advertising Code are available from the ComLaw website <http://www.comlaw.gov.au>.

Published in the Commonwealth of Australia Gazette No. GN28, 16 July 2003

COMMONWEALTH OF AUSTRALIA

THERAPEUTIC GOODS ACT 1989

THERAPEUTIC GOODS REGULATIONS

THERAPEUTIC GOODS ADVERTISING CODE: NOTICE OF AMENDMENTS

Amendment No.1

Replace the existing Clause 2.5 with -

2.5 "Healthcare Professional" includes a person defined as a healthcare professional in Therapeutic Goods Regulations 4(1), (2) and (2A) (see Appendix 2) and any other person represented directly or indirectly to be a healthcare professional.

Amendment No.2

Replace the existing Clause 4.3 with -

4.3 Comparative Advertising
Comparative advertisements must be balanced and must not be misleading or likely to be misleading, either about the therapeutic goods advertised or the therapeutic goods, or classes of therapeutic goods, with which it is compared. Points of comparison should be factual and reflect the body of scientific evidence. Comparisons should not imply that the therapeutic goods, or classes of therapeutic goods, with which comparison is made, are harmful or ineffectual.

Amendment No.3

Add the following introductory paragraph and criteria to Appendix 5 -

In considering whether or not to make a recommendation to the Secretary to amend Appendix 5 so as to permit therapeutic goods to be advertised to persons under the age of 18, the TGACC will satisfy itself on the following factors (which are not exhaustive):

1. That the likely audience could be expected to have the knowledge and maturity to self-diagnose and self-manage the condition(s) for which the goods are to be advertised;
2. That the advertising of the goods to the likely audience could reasonably be expected to deliver to them significant health benefits or significant improvements to their quality of life;
3. That the risk of over-use, misuse or inappropriate use in the likely audience is insignificant;
4. That over-use, misuse or inappropriate use of the goods is unlikely to cause significant harm;
5. That the advertising of the goods can be confined to the intended audience.

Amendment No.4

Delete all references to the "Glossary of Permissible Representations" ie.

In Appendix 6, delete the sentences:

• "The approved representation will be listed in the "Glossary of Permissible Representations" published by the TGACC from time to time;
• "for some examples of non-serious forms of these diseases, conditions, ailments and defects, refer to the "Glossary of Permissible Representations"; and
• "Permissible Representations - refer to "Glossary of Permissible Representations" for some examples".

Amendment No.5

Add the following, new Clause 4.1.3 - Incentives to pharmacy assistants and other non-healthcare professional sales persons

4.1.3 An advertisement must not offer any personal incentive to a pharmacy assistant, or other non-healthcare professional sales person at retail, to recommend or supply therapeutic goods.

For the purposes of the Therapeutic Goods Regulations, the changes set out in this NOTICE shall commence to operate on the date this NOTICE is published in the Gazette.

Dated this 2nd day of July 2003.

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