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Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)
Guidance for advertisers
Advertising different types of therapeutic goods
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.
The regulation of advertising for different types of therapeutic goods can be quite different. It is important that you understand the specific requirements related to the type of good you are advertising.
Before advertising, restricted representation approval may be required and pre-approval for advertisements of medicines to appear in specified media may be required.
Restricted scheduled substances
Restricted scheduled substances are therapeutic goods containing a pharmacist only medicine (schedule 3), prescription only medicine (schedule 4) or controlled drug (schedule 8) of the Poisons Standard. These substances need a health professional to assess whether the therapeutic good is appropriate and suitable for a patient before they are prescribed.
You cannot advertise restricted scheduled substances to the public. This is prohibited under subsection 42DL(10) of the Act and is not permitted.
There are some exceptions including:
- schedule 3 substances listed in Appendix H of the poisons standard
- prescription medicine price lists that comply with the Price Information Code of Practice (before 1 January 2019) or Schedule 4 of the 2018 Code (on or after 1 January 2019)
For information on the advertising requirements and restricted scheduled substances see:
- Advertising prescription medicines to health professionals
- Advertising cosmetic services and injections
- Advertising health services with Schedule 3, Schedule 4 or Schedule 8 medicines
For information on advertising medical devices see:
Generally, you cannot advertise biologicals to the public (section 42DL(11) of the Act).
A few biologicals are entirely excluded from the therapeutic goods legislation, while others are only excluded on the condition that they are not advertised to the public. If such biologicals were advertised to the public, they would be subject to regulation under the biological framework and the advertising requirements (including offences) would apply.
We have the authority to use various enforcement tools if your advertising does not comply with requirements.
Subject to any jurisdictional limitations, these requirements apply to advertising by any person, including health professionals, professional bodies, media outlets and commercial ventures. The requirements apply to advertising in all forms of media, including:
- traditional media (such as television, radio, print media and posters/displays)
- electronic media (such as websites, emails, blogs, discussion forums and social media).
As biologicals cannot be advertised to the public, the Therapeutic Goods Advertising Code will not generally be relevant.
Advertising of services is permitted
Services (that do not mention specific therapeutic goods) are permitted to be advertised, see advertising health services.
To advertise services and comply with the therapeutic goods legislation, the advertising should:
- focus on the services that your business provides without referencing the biological or excluded autologous human cell and tissue (HCT) product
- not make any specific reference to biologicals or excluded autologous HCT products associated with the services
- not provide information and/or advice, on medical or dental professional's (or clinics) websites, for patients to consider particular types of treatments involving biologicals or excluded autologous HCT products; however, such information can be provided to patients as part of a consultation with the professional
- not reference trade names of biologicals or excluded autologous HCT products (e.g. abbreviations, acronyms) or colloquial names such as 'stem cells'
An advertisement for a health service that specifies the use of any biological or excluded autologous HCT product associated with that service is not permitted as it would promote the product also.
Testimonials that refer to biologicals or excluded autologous HCT products are likely to be considered advertising and are subject to the same requirements.