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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
Restricted representations and advertising
This guidance is based on the advertising requirements in the Therapeutic Goods Act 1989 (the Act), including the advertising changes that came into effect on 6 March 2018. It has been further updated to provide specific information on advertising biologicals and to also include more background information on advertising requirements.
Advertising to the public must also comply with the Therapeutic Goods Advertising Code. The current version, the Therapeutic Goods Advertising Code (No.2) 2018, came into effect on 1 January 2019. To assist advertisers, we have also published guidance material on the Code: Complying with the Therapeutic Goods Advertising Code (No. 2) 2018.
Restricted representations (whether made expressly or by implication) can only be used in advertisements for therapeutic goods directed to consumers if TGA has permitted or approved the use of that representation.
What is a restricted representation?
A restricted representation is a representation (whether expressly or by implication) in an advertisement that refers to a serious form of a disease, condition, ailment or defect, as defined in the Code. See 'What is a restricted representation?'’ for more information.
Permitted restricted representations
The TGA has permitted the use of certain restricted representations by all advertisers of therapeutic goods that meet the characteristics and requirements specified by the TGA. These permitted restricted representations include:/p>
- 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
Copies of the written notices of approval or permission for the use of restricted representations are available from the published notices of approved and permitted restricted representations.
Where the TGA has permitted the use of a relevant restricted representation, advertisers do not need to apply for approval to use a restricted representation unless:
- the permission has been granted to a specific person or business
- the representations to be used are not captured by the terms of the permission
- the goods to be advertised do not meet the specifications in the permission.
Applying for approval to use restricted representations
If an advertiser wants to use a restricted representation in advertising therapeutic goods to consumers but there is no existing approval or permission, they must seek approval by submitting an application for approval to the TGA.
Approval is not required for advertising that is directed exclusively to healthcare professionals, or generic information about therapeutic goods that is not advertising (as defined in the Act).
What to consider when seeking approval
The TGA can only grant approval for the use of a restricted representation for therapeutic goods that are already entered in (or exempt from inclusion in) 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.
You should prepare your application with reference to the guidance on submitting an application for approval to use a restricted representation and the application checklist.