Applying the Advertising Code rules: restricted representations

A restricted representation is a representation (a statement or claim) in an advertisement for a therapeutic good which refers to (expressly or by implication) to a serious form of a disease, condition, ailment or defect.

A serious form means:

• that the disease, condition, ailment and/or defect is medically accepted to require 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
• 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.

A representation does not have to be a therapeutic claim to be considered a restricted representation. For example, these representations are all considered to be restricted representations:

• 'Do not use this product if you have diabetes'
• 'We proudly support Osteoporosis Australia'
• 'May help relieve pain associated with arthritis'.

The table below provides further examples of restricted representations.

The following are not restricted representations:

• pregnancy, other than pregnancy with a medical, obstetric, or surgical complication
• any of the diseases mentioned in Schedule 2 of the Regulations as these are prohibited representations.

Restricted representations can only be used in advertisements for therapeutic goods that are available to consumers if TGA has permitted or approved the use of that representation.

Approval to use a restricted representation under section 42DF of the Act can be granted following a successful application from the advertiser.

Prior to commencing an application, advertisers should familiarise themselves with the Submitting an application for approval to use a restricted representation and checklist.

A permission or approval to use a restricted representation is not required for warnings or contra-indications that are required by a legislative instrument to be included in an advertisement. These include a statement required by the following:

• the Required Advisory Statements for Medicine Labels (the Therapeutic Goods (Medicines Advisory Statements) Specification)
• the Permissible Ingredients specification (the Therapeutic Goods (Permissible Ingredients) Determination)
• the Permissible Indications specification (the Therapeutic Goods (Permissible Indications) Determination)
• the Poisons Standard

a standard that applies to the medicine (for example, Therapeutic Goods Order 92).

Applications to use a restricted representation in advertising are submitted using an online application form.

The application form is comprised of two (2) parts. Advertisers should ensure they have the necessary information and supporting documents prior to commencing their application. The application form cannot be saved and accessed at a later time.

Each application is assigned a unique identification number. Include the application number for any queries regarding your application. Send these by email to advertising.exemptions@tga.gov.au.

When deciding whether to approve or refuse the use of a restricted representation in advertising the Secretary takes into consideration the public interest criteria set out in the Code.

The public interest criteria asks 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
• have a negative impact on public health.

The public interest criteria provides a framework against which the Secretary can assess the suitability of the restricted representation for use in advertising to consumers.

The Secretary can also consider other aspects of the public interest that may be appropriate.

Prior to commencing an application, advertisers should familiarise themselves with Submitting an application for approval to use a restricted representation and checklist.

An applicant applies for permission to use a restricted representation in advertising for a specific therapeutic good. The application is made under section 42DE of the Act.

The application specifies the product (with ARTG number if applicable) and the type of restricted representation they want to make in advertising. The application includes justification for the use of the representation. Detailed guidance on how to apply for approval is available at Submitting an application for approval to use a restricted representation.

The approval given to the applicant is given under section 42DF of the Act. The approval can only be given to the applicant for a specific product/s. The TGA notifies the applicant of the result of their application as required under section 42DG of the Act.

The Secretary can however choose to issue a permission under section 42DK of the Act that permits the use of the restricted representation by a group of permitted advertisers, not only the applicant, where it is in the public interest for this to occur.

Examples of section 42DK permissions that have been issued include for the following classes of therapeutic goods:

• condoms
• broad spectrum 30+ sunscreens
• meters for monitoring blood glucose levels
• vitamin D supplements
• iron supplements
• calcium supplements
• rapid antigen tests for COVID-19
• low-dose aspirin products.

The TGA publishes approvals and permissions for both 'restricted' and 'prohibited' representations on its website at Notices of approved and permitted restricted representations.

Example

Albus applies to use the following statement in his advertising for the (fictional) Beans Tonic Lung Formula.

May assist with symptoms of cystic fibrosis by loosening and clearing lung mucus.

The ARTG indication for the product includes clearing mucus and supporting the immune system, however

• the applicant did not provide any justification that the representation is balanced and not misleading
• there is no evidence to support use of the product in any specific disease or condition.

The application is refused under section 42DF(2) of the Act. The delegate is not satisfied that the restricted representation is accurate, balanced and not misleading or likely to be misleading.

Example

Mohammad applies on behalf of a pharmacy marketing group to advertise an automated external defibrillator. The representation he proposes to use has already been permitted under a section 42DK of the Act. The TGA informs Mohammad of the existing s42DK permission. He withdraws his application.

Prohibited representations must not be used in advertising unless permitted by the TGA.

Prohibited representations are those representations that refer to the following:

• neoplastic diseases (e.g. all types of cancer)
• sexually transmitted diseases
• HIV/AIDS
• Hepatitis C virus
• mental illness
• an abortifacient action.

Other prohibited representations apply to other specific types of therapeutic goods including:

• analgesics
• disinfectants and antiseptics
• vitamins and minerals.

For details about prohibited representations refer to Schedule 2 of the Regulations. Schedule 2 applies to all advertising of therapeutic goods.

The TGA publishes approval and permissions for both 'restricted' and 'prohibited' representations at Advertising permissions. 

In limited circumstances, the TGA may permit the use of prohibited representations if the representation is:

• in the interest of public health, or
• necessary for the appropriate use of the goods
  • this applies to packaging, labelling or material included with the goods.

Examples of section 42DK permissions that have been issued for prohibited representations include:

• Sunscreens
• Condoms
• HIV self-test kits.