Restricted representations

What is a restricted representation?

A restricted representation is representation that refers, whether 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 (the Code), means a form of a disease, condition, ailment and/or defect where:

• 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.

However, the following are not considered to be serious forms of a disease, condition, ailment and/or defect, within the meaning of the Code:

• pregnancy, other than pregnancy with a medical, obstetric or surgical complication; or
• any of the diseases mentioned in section 30 of the Code (which are prohibited representations).

A representation does not have to be a therapeutic claim to be considered a restricted representation. For example, the representations: 'Do not use this product if you have diabetes', 'We proudly support Osteoporosis Australia' and 'may help relieve pain associated with arthritis' are all considered to be restricted representations.

Using restricted representations

It is an offence to advertise therapeutic goods to consumers using restricted representations unless the TGA has issued a relevant approval or permission. See When can I use a restricted representation? for more information.

Advertising (including labelling)

If an advertiser wishes to use restricted representations in advertising (including on labels) but there is no relevant approval or permission in force, they must submit a formal application to the TGA via the 'Application for approval to use a restricted representation in advertising' online form.

Prior to commencing an application, advertisers should familiarise themselves with the related guidance and checklist.

Relevant sections of the Act

Definitions

SECTION 3

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

1. If an application for approval of the use of a restricted representation is made, the Secretary (or delegate) must approve the use of the restricted representation if the Secretary (or delegate) is satisfied that:
   1. the representation is accurate and balanced; and
   2. the representation is not misleading or likely to be misleading.
2. Otherwise, the Secretary must refuse to approve the use of the restricted representation.
3. An approval may be subject to conditions imposed by the Secretary.
4. In deciding whether to approve or refuse to approve the use of a restricted representation, the Secretary must take into consideration:
   1. any advice of a committee that is established under the regulations and is prescribed by the regulations for the purposes of this paragraph; and
   2. the public interest criteria mentioned in the part of the Therapeutic Goods Advertising Code dealing with restricted representations.

Section 42DK - Permitted use of restricted or prohibited representations

Restricted representations

1. The Secretary may, by writing, permit the use of specified restricted representations in specified advertisements about specified therapeutic goods.

Prohibited representations

2. The Secretary may, by writing, permit the use of specified prohibited representations:

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

   if the Secretary is satisfied that the representations are necessary for the appropriate use of the goods.

3. The Secretary may, by writing, 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.

Conditions

4. A permission under this section may be subject to conditions specified in the permission.

Permission not a legislative instrument

5. A permission under this section is not a legislative instrument.

Publication

6. As soon as practicable after giving permission under this section, the Secretary must cause the permission to be published on the Department's website.