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Restricted representations

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:

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

Using restricted representations

Advertising (including labelling)

If an advertiser wishes to make reference to a restricted representation in advertising, including on labels, then a formal application to the Delegate of the Secretary is required (Section 42DE of the Therapeutic Goods Act 1989 refers, see below extract). This request must be made via the 'Application for approval to use a restricted representation in advertising' online form. It should be completed in conjunction with the related guidance.

Relevant sections of the Act

SECTION 3 - Definitions

advertise, in relation to therapeutic goods, includes make any statement, pictorial representation or design that is intended, whether directly or indirectly, to promote the use or supply of the goods, including where the statement, pictorial representation or design:

  1. is on the label of the goods; or
  2. is on the package in which the goods are contained; or
  3. is on any material included with the package in which the goods are contained.

label, in relation to therapeutic goods, means a display of printed information

  1. on or attached to the goods; or
  2. on or attached to a container or primary pack in which the goods are supplied; or
  3. supplied with such a container or pack.

ADVERTISEMENTS (including labels)

Section 42DE - Applications for approval of use of restricted representation

  1. An application for approval of the use of a restricted representation must be made to the Secretary in accordance with a form approved, in writing, by the Secretary.
  2. An approval of a form may require or permit an application to be given in accordance with specified software requirements:
    1. on a specified kind of data processing device; or
    2. by way of a specified kind of electronic transmission.

Section 42DF - Approval of use of restricted representation

Section 42DF stipulates that:

The decision to approve, or to refuse to approve, is made by the Secretary to the Department of Health (or the delegate).

The Secretary (or delegate) must approve the use of the restricted representation if the Secretary 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:

  • any advice of a committee that is established under the regulations and is prescribed by the regulations for the purposes of this paragraph; and
  • the public interest criteria mentioned in the part of the Therapeutic Goods Advertising Code dealing with restricted representations.

Section 42DK - Use of restricted or prohibited representation

  • Section 42DK(1) allows the Secretary to permit the use of a restricted representation in specific advertisements for specific therapeutic goods.
  • Under Section 42DK(2), the Secretary can permit a prohibited representation to be included on the label of specified therapeutic goods, on the package in which specified therapeutic goods are contained, or in information included in the package in which therapeutic goods are contained, if the representation is necessary for the appropriate use of the goods.
  • Section 42DK(3) allows the Secretary to permit the use of specified prohibited representations in specified advertisements about specified therapeutic goods if the Secretary is satisfied that the representations are necessary in the interests of public health.
  • Permissions made under section 42DK may be subject to conditions.