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Frequently Asked Questions

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Frequently Asked Questions

1   What is the Therapeutic Goods Advertising Code (TGAC)?
The TGAC is a set of principles and guidelines that ensures socially responsible marketing and advertising of therapeutic goods in a way that will promote the appropriate use of these products. All advertisements and generic information provided about therapeutic goods directed to consumers must comply with the TGAC.

2   What are therapeutic goods?
Therapeutic goods include medicines available by prescription only; non-prescription, over-the-counter (OTCs) or proprietary medicines; complementary healthcare products (such as mineral, herbal and vitamin supplements, homeopathic and aromatherapy products) and certain healthcare devices.

With a few exceptions, only therapeutic goods that are on the Australian Register of Therapeutic Goods (ARTG) may make therapeutic claims. These products can be recognised by an AUST L or AUST R number on the label.

3   What products may be advertised to the public?
Healthcare products available without prescription from pharmacies, health food stores, supermarkets and by direct marketing can be advertised to the public.

4   Do I need formal approval for advertisements?
YES, all advertisements for designated therapeutic goods published for valuable consideration in the following media must be approved.

Broadcast: television, radio and cinema

Print: newspapers and magazines (including inserts)

Display: including billboards, bus shelters, bus sides and interiors and taxis displays.

5   What advertisements don'¬ít require approval?
Advertisements not displayed outdoors, such as indoor posters, leaflets, brochures, catalogues, point-of-sale material, facts sheets, shelf wobblers and the internet do not require formal approval. Nor do advertisements for therapeutic devices.

However, they must comply with the Therapeutic Goods Act, Regulations and the Code.

6   Who approves advertising?
The Advertising Services Offices of the ASMI and the CHC approve advertisements.

All broadcast advertisements. All over-the-counter(OTC) non-prescription medicines advertisements in specified media:

Advertising Services Manager
Australian Self-Medication Industry
PO Box 764
North Sydney NSW 2059
Tel: (02) 9955 7205
Fax: (02) 9957 6204
email: asmiadvertising@asmi.com.au
All complementary (i.e. herbal, aromatherapy, vitamin and mineral supplements) specified media advertisements (other than broadcast).

Advertising Services Manager
Complementary Healthcare Council
PO Box 820
MAWSON ACT 2607
Email: tricia.campbell@chc-advertising.com.au

7   Do I get an approval number?
All advertisements that require approval are allocated an approval number. All advertisements, other than those in broadcast media (including any material inserted in newspapers/magazines), must display the approval number. The approval number in print media advertisements must be prominently displayed in the bottom right hand corner of the advertisement.

8   Are there any costs involved?
A fee for service is charged for all advertisements that are submitted to either of the two Advertising Services Offices. See the schedule of fees in the Regulations: Schedule 9, Part 2, Column 1 items 17 and 17A

9   How long does it take to get approval?
While the time limit set in the Regulations is 60 days, this is never applied. Depending on the nature and content of the material the turn-around time normally ranges between 5 and 10 working days.

10   What is the role of the Therapeutic Goods Advertising Code Council (TGACC)?
The TGACC reviews the Code and its operation to ensure that it remains current and relevant.

11   What does the Complaints Resolution Panel do?
The Complaints Resolution Panel (CRP) determines complaints about advertisements (whether or not approved) and generic information about therapeutic goods, including devices, broadcast on television, radio, the internet, exhibited in cinemas, published in newspapers and magazines or displayed outdoors, such as on billboards, posters, bus shelters, bus sides and interiors and taxis.

12   What about complaints about other advertisements?
Complaints regarding advertisements on indoor posters, leaflets, letterbox drops, brochures, catalogues, point-of-sale material, facts sheets, shelf wobblers, as well as advertisements directed to healthcare professionals, are handled by different industry associations including the ASMI and the CHC

13   What happens if an advertisement or generic information is found to have breached the Code?
If the CRP decides that an advertisement or generic information has breached the Code, as part of its determination, the Panel may make request(s) of the advertisers/sponsors [Reg. 42ZCAI(1) and (2)]. The Panel has no power to impose penalties. If the request is not complied with within 14 days, the Panel may make recommendations to the Secretary who may order withdrawal of the advertisement (or generic information) or the publication of a retraction or correction. The Panel may also recommend that the Secretary order an advertiser not to repeat misrepresentations. In extreme cases, regulatory action to remove the product from the market may be necessary. When the decision-maker acts on a recommendation, the action can be challenged by ministerial review followed by an appeal to the Administrative Appeals Tribunal (AAT).

Where a complaint is found not justified, the Panel makes no recommendation. There is, therefore, no process of appeal to the Secretary, the Minister or the Administrative Appeals Tribunal, although the matter may always be taken to the Federal Court of Australia or to the courts of a State or Territory.