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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
Restricted representations and advertising
This guidance for advertisers applies to the current Therapeutic Goods Advertising Code 2015 but incorporates amendments to the Therapeutic Goods Act 1989 (the Act) that came into effect on 6 March 2018, and has been further updated to provide specific information on advertising biologicals and to also include more background information on advertising requirements.
The Therapeutic Goods Advertising Code (No.2) 2018 was made on 31 October 2018 to replace the 2018 Code which will come into effect on 1 January 2019. A summary of the changes is available. To assist advertisers with implementation, we have also published guidance material; Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
You may only use a restricted representation (either expressly or by implication) in an advertisement for therapeutic goods directed to the public if TGA has permitted or approved the use of that representation. TGA has permitted the use of some key restricted representations for commonly advertised therapeutic goods. However, in many cases, you will need to apply to the TGA for prior approval from us for such use.
What is a restricted representation?
A representation in an advertisement about therapeutic goods that refers to a serious form of a disease, condition, ailment or defect, as specified in the Code, is a restricted representation.
The Code sets out the definition of serious for the purposes of determining which diseases, conditions, ailments and defects would constitute such a reference.
Any representation in an advertisement for a therapeutic good can be a restricted representation if the representation refers (whether overtly or impliedly) to a serious form of a disease, condition, ailment or defect. The representation does not have to be a therapeutic claim to be a restricted representation. For example, the representations: 'Do not use this product if you have diabetes' and 'We proudly support Osteoporosis Australia' and 'may help relieve pain associated with arthritis' are all considered to be restricted representations.
Permitted restricted representations
TGA has permitted the use of certain restricted representations by all advertisers of therapeutic goods meeting the characteristics and requirements specified by the TGA. The permitted restricted representations include:
- certain neural tube defect risk reduction in pregnancy representations when advertising medicines that deliver a minimum of 400 micrograms of folic acid in a daily dose
- representations about reducing the risk of osteoporosis when advertising medicines that deliver a minimum of 290mg of elemental calcium in a daily dose
- representations about sleep apnoea, Obstructive Sleep Apnoea (OSA) and Central Sleep Apnea/Apnoea (CSA) in relation to Continuous Positive Airway Pressure (CPAP) equipment
Details of permissions are available from the published notices of approved & permitted restricted representations.
Unless the permission has been granted to a specific person or business, all advertisers promoting therapeutic goods that are the subject of these permissions are exempted.
It is not necessary to apply for approval to use restricted representations that have already been permitted by the TGA, unless your claims or goods are not captured by the terms of the permission.
Applying for approval to use restricted representations
You are required to make an application to TGA before using a restricted representation in an advertisement for therapeutic goods which is directed to the public if there is no existing permission. This includes representations made on the product's labels and other advertising. You do not require such approval for advertising to healthcare professionals and in generic information.
What to consider when seeking approval
We can only grant approval for the use of a restricted representation for therapeutic goods that are already entered in (or exempt from inclusion on) the ARTG.
Any proposed restricted representation must be consistent with:
- the product's accepted indications or intended purpose, as per its ARTG entry; and/or
- any mandatory warning or cautionary statements which are required to be included in the product packaging/labelling in order to satisfy other regulatory requirements.
Assessing an application to use a restricted representation
Factors we consider when assessing an application
When we assess an application to use a restricted representation, we consider whether the proposed representation is accurate, balanced and not misleading or likely to be misleading. In forming a view about these requirements, we consider various factors including:
- the context in which the proposed representation will be used
- the actual wording of the proposed representation
- substantiating evidence provided to justify the use of the proposed representation and to satisfy TGA that the use of the representation will be accurate
- any relevant information the decision maker may be aware of
- the public interest criteria specified in the Code.
You do not need to provide specific examples of advertising and it should be noted that advertisements in their entirety are not approved. However, you may wish to provide a specific example or examples with your application to provide support and context in relation to the proposed use of the restricted representation.
Public interest criteria
We take public interest criteria, as set out in the Code, into account when considering an application for approval to use a restricted representation in an advertisement. Include a statement in your application to explain to TGA how you see the public interest criteria applying to your proposed representation and advertising.
The public interest criteria consider whether the reference to a serious form of a disease in the advertisement is likely to:
- take advantage of the vulnerability of consumers
- result in consumers not seeking appropriate medical advice
- have a negative impact on public health.
The Secretary can also take into account other aspects of public interest that appear to be appropriate.
Decision to approve or refuse an application
The decision to approve, or to refuse to approve, is made by the Secretary to the Department of Health (or his or her delegate at TGA). However, the Secretary (or delegate) may seek advice from the Advisory Committee on Non-Prescription Medicines (ACNPM), the Advisory Committee on Complementary Medicines (ACCM) or the Advisory Committee on Medical Devices (ACMD) about the application prior to making their decision.
The Secretary must take into consideration any recommendation made by the committees prescribed under Regulation 6AA, which include ACNPM or ACCM (section 42DF of the Act).
Applicants that are not satisfied with the decision in relation to an application can seek a review of that decision. Details on how to seek a review will be set out in the decision letter issued by TGA.