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Approvals

The Approval Process

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The Approval Process

Brief overview of regulatory requirements

All advertising of Therapeutic Goods directed to consumers must by law comply with the requirements and standards of the Therapeutic Goods Advertising Code , the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990 . To ensure that the standards developed for the public benefit over the last 30 years are met in all specified media advertising, a system of approval for all advertisements is applied before broadcast or publication.

Background

Therapeutic Goods Regulations 400 , which was gazetted on 18 December 1997, formalized the prior approval of advertisements intended for publication in mainstream print media. In April 2000 the requirement for formal approval of advertisements was extended to include cinematographic film and outdoor media advertising. Until recently, the Broadcasting Services Act 1992 required that advertisements relating to medicines be approved by the Secretary of the Department of Health, or a nominated delegate, prior to broadcast. This requirement applied to all radio and television media. The Act was amended in December 1990, delegating the authority to approve advertisements in broadcast media to the Proprietary Medicines Association of Australia now called the Australian Self-Medication Industry ( ASMI ). The requirements in the Broadcasting Services Act were transferred to the Therapeutic Goods Act in December 2003.

Which advertisements require formal approval?

specified media advertisements: television, radio, print, cinema and outdoor
The authority to approve or not approve an advertisement rests with the Secretary of the Department of Health and Ageing. In the event of a non-approval, the Secretary must give reasons for the refusal and inform the applicant of his/her right to have the Secretary's decision reviewed by the Minister. The Minister must take into account any recommendation by the TGACC. The Minister's decision in turn may be reviewed on application to the Administrative Appeals Tribunal.

The regulations make provision for the Minister to delegate the approval function as follows:

  • all broadcast advertising to the Australian Self-Medication Industry.
  • mainstream print, cinema and outdoor advertising of all over-the-counter (OTC) non-prescription medicines to the Australian Self-Medication Industry.
  • mainstream print, cinema and outdoor advertising of complementary healthcare products to the Complementary Healthcare Council of Australia.

The aims of the approval process are:

  • to ensure compliance with The Act, Regulations and the TGAC,
  • to ensure consistency of allowed claims for similar products and for different advertisements of the same product over time,
  • to ensure decisions are consistent and objective, and
  • to ensure that claims are factual.

Submitting advertisements for approval

To have an advertisement approved, it must be submitted to the appropriate Advertising Services Office. If it is the first proposed advertisement submitted for a particular product, or if the product has been changed (e.g. labelling alterations, modifications to approved indications) the following documentation should be provided to the appropriate Advertising Services Office, either by mail, facsimile or e-mail:

  1. Print: typed copy - black on white background.
  2. Print: layout – clear description of the layout with copies of all visuals/graphics/packshots.
  3. TVC: copy of script with storyboard.
  4. Radio: copy of script with sound-effect descriptions.
  5. Copy of supporting documentation:
    A – certificate of listing/registration
    B – label (enlarged for legibility)
    C – approved indications for use as entered on the ARTG (where applicable).
    D – research/surveys/data referenced in advertisement (see note below).
    E – for professional recommendations and testimonials (see note below).
    F – completed application form, available on the advertising pages of www.tga.gov.au .

Note: Substantiation of claims is to be provided upon request. Substantiation, in line with levels of evidence required to be held by the sponsor at the time of listing or registration, may be required by the advertising services manager. Notwithstanding this, further substantiation may also be requested. Listing or registration of a claim does not automatically mean that the claim may be advertised.

Print advertisements for complementary medicines:
The Advertising Services Office
Complementary Healthcare Council of Australia
PO Box 820, Mawson ACT 2607
Tel: (02) 6260 4066
Fax: (02) 6260 4122
E-mail: advertising@chc.org.au
website: www.chc.org.au/chc_frame_advertisingclearance.html

Print advertisements for other non-prescription (OTC) medicines:
The Advertising Services Office
Australian Self-Medication Industry
PO Box 764, North Sydney NSW 2059
Fax: (02) 9957 6204
e-mail: adservices@asmi.com.au
website: http://www.asmi.com.au/advertising.htm

Broadcast advertisements for all complementary and OTC medicines:
The Advertising Services Office, Australian Self-Medication Industry (address as above)

Fees

All advertisements submitted for approval are subject to a fee, based on a fee-for-service principle and calculated to cover costs. Refer to the attached schedule of fees.

Approval process

The proposed advertisement will be reviewed and the advertiser notified of any changes or claim substantiation that may be required before the advertisement can be approved.

A distinguishing approval number is allocated for each approved advertisement and this number must be displayed in print advertisements. Publishing or inserting in mainstream print media an advertisement without its approval number, constitutes a breach of the Therapeutic Goods Act and is liable to a fine.

Approvals are valid for a period of 2 years and once an approval has expired, the advertisement must be submitted for re-approval.

How long does the approval process take?

The Regulations allow for a period of 60 days; this is totally unrealistic in advertising practice. Every reasonable effort is made to process advertisements within 10 working days, provided all the relevant material is received in the first instance.

What happens if an advertisement is not approved?

Should a particular proposed advertisement not be approved in spite of all reasonable attempts to ensure compliance with The Act, the Regulations and the Code, the advertiser has a right to have the decision reviewed by the Minister. A request for the review must, within 30 days of the notice of non-approval of the advertisement, be sent to:

The Assistant Minister for Health
Parliament House
Canberra ACT 2600
AND The Secretariat
Therapeutic Goods Advertising Code Council
Level 13 Macquarie House,
167 Macquarie Street
Sydney NSW 2000
Phone: 02 8667 3026 or 02 8667 3025