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Application for approval to use a restricted representation in advertising

25 May 2012

This form should be used when applying for approval to use a restricted representation in advertising a therapeutic product.

A restricted representation is a reference, expressly or by implication, to forms of diseases, conditions, ailments or defects which are generally accepted to be:

• not appropriate to be diagnosed and/or treated without consulting a suitably qualified healthcare professional; and/or
• beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a qualified healthcare professional.

More information

Examples of restricted representation are available at Restricted Representations, and more information plus guidance on submitting your application is available below.

Application form

This form is available in pdf and Microsoft Word formats. The pdf form can be filled in and saved to your computer using Adobe Reader version 7 or later or any version of Adobe Acrobat Standard or Professional. If you have an earlier version of Adobe Reader you can fill in the form on-screen and print it out but you will not be able to save the completed form.

• Application for approval to use a restricted representation in advertising (pdf,129kb)
• Application for approval to use a restricted representation in advertising (Microsoft Word,1.72Mb)

Guidance for submitting an application for approval to use a restricted representation under Section 42DF of the Therapeutic Goods Act 1989

What is a restricted representation?

A restricted representation is a reference, expressly or by implication, to serious forms of diseases, conditions, ailments or defects. Serious, in the context of the Therapeutic Goods Advertising Code 2007, means forms of diseases, conditions, ailments or defects that are:

• generally accepted not to be appropriate to be diagnosed and/or treated without consulting a suitably qualified healthcare professional; and/or
• generally accepted to be beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a qualified healthcare professional.

Please refer to section 5(2) and Table 1 of Part 2 of Appendix 6 the Therapeutic Goods Advertising Code 2007 for the list of restricted representations.

Which therapeutic goods can seek approval to use a restricted representation?

Approval for the use of a restricted representation can be granted only for therapeutic goods entered or therapeutic goods exempt from inclusion on the Australian Register of Therapeutic Goods (ARTG).  Any proposed restricted representation must be consistent with:

1. the product's accepted indications or intended purpose, as per its ARTG entry; and/or
2. any mandatory warning or cautionary statements which are required to be included in the product packaging/labelling in order to satisfy other regulatory requirements

Do restricted representations apply to Registered or Listed medicines?

For medicines, where the proposed restricted representation relates to the product's indications, applicants should note that such products must first be included in the ARTG as REGISTERED medicines, prior to seeking approval to use a restricted representation in consumer advertising.

There may be some limited circumstances where approval could be given to a listed medicine for the use of a restricted representation, but only where:

• the proposed representation refers to risk factors associated with a serious form of a disease, condition, ailment and/or defect; and
• a clear public health benefit of such advertising can be demonstrated (in line with the Public Interest Criteria).

When is permission to use a restricted representation required?

This is required before using the representation, either by reference to it or in making a claim, in advertising therapeutic products to consumers.

It is not required for

• advertising to healthcare professionals
• generic information

What can a restricted representation apply to?

The approval for the use of a restricted representation may be given to:

• a group of products, e.g. condoms, broad spectrum 30+ sunscreens, meters for monitoring blood glucose levels;
• a substance, e.g. vitamin D;
• a substance limited to a specific company for some products, e.g. paracetamol-only products sponsored by company X;
• a substance limited to a specific company for specific Stock Keeping Units (SKUs), e.g. Metamucil (4 only); or
• a specific product, e.g. Mediflexor Calf Carer, Diflucan Duo

Applicants, therefore, need to consider carefully the scope of the restricted representation they wish to make, e.g. either a category or limited to the brand/product.  If the applicant wishes to confine the restricted representation to a particular brand/product, it may be helpful for the submission to include some justification for doing so.

Applicants should be aware that:

• the TGACC may recommend a category exemption, even where the application is made for a particular product or recommend amendments to the use of the restricted representation; and
• reference to prescription products or substances in Schedule 4 of the Poisons Standard (S4) is prohibited under section 42 DL(1)(f) of the Therapeutic Goods Act 1989.

Who considers the application and who is the decision-maker?

The decision to approve, or to refuse to approve, is made by the Secretary to the Department of Health & Ageing (or the delegate).  However, the Secretary (or delegate) will, in most cases, seek advice from the TGACC, the Advisory Committee on Non-Prescription Medicines (ACNPM) or the Advisory Committee on Complementary Medicines (ACCM) about the application prior to making his / her decision.  The Act (s.42DF) states that the Secretary must take into consideration any recommendation made by the TGACC, ACNPM or ACCM.

Do I need to provide specific examples of advertising?

No, specific examples of advertising are not required. However, you may wish to provide a specific example or examples with your application if they could provide support and context in relation to the proposed use of the restricted representation.

What are the public interest criteria to which reference is made in the application form?

Public interest criteria to be applied by TGACC

In considering an application for approval to include in an advertisement a reference to a disease, condition, ailment or defect specified in Part 2 of Appendix 6, the Secretary may consult the TGACC.  In making a recommendation to the Secretary, the TGACC must take into account:

1. Consumers, or certain groups of consumers, vulnerability when faced with the disease, condition, ailment or defect;
2. Whether the reference would be likely to result in consumers not seeking timely professional advice where appropriate (such as where timely professional advice is important to prevent negative health consequences or irrevocable deterioration or progression of disease);
3. Whether the reference would be likely (alone or through repetition or together with other references) to have a negative impact on public health (or to have an effect on persons other than those to whom the advertisement is directed); and
4. Such other aspects of the public interest as may appear to be appropriate.
5. The World Health Organization notes that responsible self-medication can:
   • Help prevent and treat symptoms and ailments that do not require medical consultation;
   • Reduce the increasing pressure on medical services for the relief of minor ailments, especially when financial and human resources are limited;
   • Increase the availability of health care to populations living in rural or remote areas where access to medical advice may be difficult; and
   • Enable patients to control their own chronic conditions.

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