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Guidance for submitting an application for approval to use a restricted representation

Using a restricted representation under Section 42DF of the Therapeutic Goods Act 1989

28 June 2019

What is a restricted representation?

A restricted representation is a reference, expressly or by implication, to a serious form of a disease, condition, ailment or defect. Serious, in the context of the Therapeutic Goods Advertising Code (No.2) 2018 (the Code), means forms of diseases, conditions, ailments or defects that:

  • are medically accepted to require diagnosis, treatment or supervision by a suitably qualified health professional, except where it has been medically diagnosed and medically accepted as being suitable for self-treatment and management; or
  • have a diagnostic (including screening), preventative, monitoring, susceptibility or pre-disposition test available (including a self-administered test), which requires medical interpretation or follow-up.

Before using a restricted representation when advertising therapeutic goods, you must have a prior approval or permission from the Secretary of the Department of Health (or their delegate).

What is the difference between an approval and a permission to use restricted representations?

Before a restricted representation can be used in an advertisement (including labelling), the representation must be either:

  • approved by the Secretary under section 42DF of the Therapeutic Goods Act 1989 (the Act); or
  • permitted by the Secretary under section 42DK of the Act.

Approval to use a restricted representation can only be granted following receipt of an application from the advertiser. However, the Secretary can permit the use of a restricted representation without receipt of an application.

Can restricted representations be used in the advertising of any type of therapeutic good?

Approval for the use of a restricted representation can be granted only in relation to therapeutic goods that:

  1. can be lawfully advertised to the public (e.g. not prescription medicines), and
  2. are either entered, or exempt from inclusion, in 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 I need restricted representation approval or permission for label warnings or contraindication?

Restricted representation approval or permission for references to serious forms of diseases, ailments, defects or conditions is not needed for warnings, contraindications or advisory statements, provided that the warning, contraindication or advisory statement is required under the therapeutic goods legislation to be included in that form of advertising (e.g. the label).

Australian requirements for non-prescription medicines (Therapeutic Goods Orders 69 and 92) require the labels for some over-the-counter and complementary medicines to contain particular contraindications or warning statements (collectively, advisory statements) about specific risks related to their use. In addition, the the Code requires advertising for medicines containing certain ingredients, for which the Code sets out, to contain particularly serious advisory statements (identified in the Code as health warnings) or to advise consumers to read the label (and therefore the advisory statements) before purchase. Compliance with other aspects of the therapeutic goods regulatory scheme (for example, conditions of marketing approval) may also involve the inclusion of advisory statements on product labels.

Some of these required advisory statements and health warnings may contain references to serious diseases, conditions, ailments or defects.  Generally, such references may be considered to be restricted representations under the the Act. The Act provides criminal offences and civil penalty provisions in relation to advertising, including product labels, containing restricted representations for which the Secretary has not given prior approval or permission (subsections 42DL(7) and 42DLB(4) of the Act refer).

However, the TGA will not require an approval under section 42DF of the Act or a permission under section 42DK of the Act to be necessary for the use of an advisory statement in advertising for a medicine in relation to which the statement is required as part of any of the following:

This advice only applies in relation to the use of such statements in advertising when that use is required under one or more of the measures noted above. The use of such statements in these contexts is required in order to provide and highlight critical safety information for consumers. However, if used inappropriately and not in a manner to highlight that safety information, these statements may have unintended consequences.

If such statements are used outside of the contexts listed above, the Secretary’s approval or permission will be required prior to their use. In the absence of such approval or permission, criminal offences or civil penalties in the Act may apply.

Will a restricted representation approval or permission be limited to a particular product?

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

  • a group of products, e.g. condoms, broad spectrum 30+ sunscreens, meters for monitoring blood glucose levels
  • products containing a particular 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 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 a particular 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 Secretary may decide to issue a category exemption, even where the application is made for a particular product.

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

The decision to approve, or to refuse to approve, an application is made by the Secretary of the Department of Health (or the delegate). The Secretary (or delegate) must approve the use of the restricted representation if she or he is satisfied that:

  • the representation is accurate and balanced; and
  • the representation is not misleading or likely to be misleading.

Otherwise, the Secretary must refuse to approve the use of the restricted representation.

An approval may be subject to conditions imposed by the Secretary.

In deciding whether to approve or refuse to approve the use of a restricted representation, the Secretary must take into consideration:

  • the public interest criteria mentioned in the part of the Therapeutic Goods Advertising Code dealing with restricted representations, and
  • any advice the Secretary may have sought from:
    • Advisory Committee on Medicines;
    • Advisory Committee on Complementary Medicines;
    • Advisory Committee on Medical Devices; or
    • Advisory Committee on Vaccines.

Do I need to provide specific examples of advertising with my application?

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?

Section 42DF of the Act requires that the Secretary (or delegate) take into consideration the public interest criteria set out in the Code when deciding whether to approve, or refuse to approve, the use of a restricted representation in advertising.

The public interest criteria contemplate whether the reference to a serious form of a disease in an advertisement would be likely to:

  • take advantage of the vulnerability of consumers or particular groups of consumers, when faced with the disease, condition, ailment or defect
  • result in consumers not seeking medical advice at an appropriate time (also refer to section 10(b) of the Code)
  • have a negative impact on public health.

The Secretary (or delegate) can also take into account other aspects of public interest that may be appropriate.

The public interest criteria provide a framework against which the Secretary (or delegate) can assess the suitability of the restricted representation for use in advertising to consumers.

An application for approval to use restricted representations should include a statement from the applicant setting out how the public interest criteria apply to their advertisement and goods.