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Advertising: Advertising Code and guidance

13 December 2019

The Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG)

The Australian Regulatory Guidelines for Advertising Therapeutic Goods (ARGATG) provides information to advertisers about:

  • advertising compliantly under the regulatory framework
  • the requirements for advertising different types of therapeutic good
  • approvals that are needed before advertising
  • enhanced sanctions and penalties for non-compliant advertising
  • the kinds of activities that represent advertising
  • advertising therapeutic goods with related services
  • advertising specific types of therapeutic goods
  • advertising interface products
  • the handling of advertising complaints

Therapeutic Goods Advertising Code (the Code)

The Code sets the requirements advertisers must meet to ensure the marketing and advertising of their therapeutic goods is:

  • conducted in a manner that promotes the quality use of the product
  • socially responsible
  • doesn't mislead or deceive the consumer

The Therapeutic Goods Advertising Code (No.2) 2018 originally took effect on 1 January 2019 and was amended on 30 July 2019.

Further information about the amendments to the Code is available. Information about previous versions of the Advertising Code is also available.

Guidance: Advertising to the public

We have published guidance to help advertisers comply with the Therapeutic Goods Advertising Code (No. 2) 2018. This guidance aims to provide further information about the understanding, interpretation and application of the Code. This guidance is being updated to reflect the changes made to the Code in July 2019.

Questions and answers on the Advertising Code

During our training sessions and webinars on the Therapeutic Goods Advertising Code (No.2) 2018 (the Code), we received a large number of queries that we undertook to publish responses to.

We have released answers to some of the most common questions and will add to these on a regular basis.

Restricted representations

A restricted representation is any reference expressly or by implication, to a serious disease, condition, ailment or defect which is generally accepted to be:

  • not appropriate to be diagnosed and/or treated without consulting a suitably qualified health professional; and/or
  • beyond the ability of the average consumer to evaluate accurately and to treat safely without regular supervision by a qualified health professional.

Application for approval to use a restricted representation in advertising
Form to apply for approval to use a restricted representation in advertising

Restricted representations
Detailed information on the use of restricted representations in advertisements

Notices of approved & permitted restricted representations
These are the written notices of approval or permission for the use of restricted representations in advertising therapeutic goods to consumers

Cancelled and suspended therapeutic goods cannot be advertised to the public

Therapeutic goods that are not entered in the Australian Register of Therapeutic Goods (ARTG) cannot be advertised to the public[1].

Subsection 42DL(12) of the Therapeutic Goods Act 1989 (the Act) sets out that an advertisement directed to the public must not refer to:

therapeutic goods that are not entered in the Register[2] and that are prescribed by the regulations for the purposes of this subsection, other than a reference authorised or required by a government or government authority (not including a foreign government or foreign government authority).

Cancelled and suspended therapeutic goods are considered not to be entered in the ARTG and cannot be advertised or commercially supplied in Australia.

Even if the cancelled or suspended goods can be made available to consumers via the special access schemes or other unapproved goods access pathways, they must not be advertised to the public.

Further, cancelled and suspended goods will be captured by the Therapeutic Goods Regulations 1990 for the purposes of ss.42DL(12). To date, the TGA has not authorised or required a reference to cancelled or suspended goods in advertising and therefore goods that have been cancelled or suspended from the ARTG cannot be advertised to the public.

Cancelled goods

Goods that have been cancelled from the ARTG (whether by the TGA or the sponsor) cannot be advertised to the public as they are goods that are not entered in the Register and ss.42DL(12) applies.

In relation to medicines, s.30 of the Act sets out the conditions under which the Secretary can cancel the registration or listing of a therapeutic good.

In relation to medical devices, s.41GM of the Act sets out the conditions under which the Secretary can cancel the registration or listing of a therapeutic good.

Advertisers can check whether a therapeutic good has been cancelled from the ARTG through the following:

Suspended goods

Goods that are suspended from the ARTG cannot be advertised for the duration of the period of suspension. For the duration of the suspension, they are considered to be goods that are not entered in the ARTG and therefore ss.42DL(12) applies.

In relation to medicines s.29G of the Act sets out:

If the registration or listing of therapeutic goods is suspended under section 29D, the goods are taken, for the purposes of this Act (other than sections 28, 29A, 29AA, 29E, 29F, 30 and 31), not to be included in the Register while the suspension has effect

In relation to devices ss.42GI sets out:

If all or some medical devices of a particular kind are suspended, they are taken, for the purposes of this Act (other than Division 2 of Part 4 5, this Division and Part 4 8), not to be included in the Register while the suspension has effect.

Advertisers can check to see whether a therapeutic good has been suspended from the ARTG through the suspensions page.

There are offences and civil penalties for advertising cancelled or suspended therapeutic goods

The TGA has a range of compliance and enforcement tools available to detect, deter and address the illegal advertising of cancelled and suspended therapeutic goods. These tools may include criminal or civil court proceedings, which can result in substantial fines or imprisonment.

The TGA has previously issued an Infringement notice for advertising a therapeutic good after it had been cancelled from the ARTG.

Complaints handling

Complaints about the advertising of therapeutic goods that have been cancelled or suspended from the ARTG will be handled in the same way as complaints about the advertising of any other type of therapeutic good. All complaints are handled in accordance with the TGA’s advertising complaints handling framework.


Footnotes


Pre-approval

Fact sheet - Requirements for pre-approval
Advertisements for medicines require pre-approval before they can appear in 'specified media' (such as television, radio, magazines and newspapers)

Application for approval of advertising for medicines
This form is for applying for the approval of advertisements in specified media to which Division 2 of Part 2 of the Therapeutic Goods Regulations applies

For additional educational tools and fact sheets to help you understand your advertising requirements, see Advertising basics, general information and enquiries.

Other resources

Guidance

Therapeutic goods advertising: Ensuring 'natural' claims are not misleading
This guidance provides information for industry on how claims about the 'naturalness' of a particular therapeutic good and/or its ingredients can be made without misleading consumers

Guidelines for advertisements for medicines containing Schedule 3 substances
This guidance is for those interested in the advertising of pharmacist-only medicines

Sample social media acceptable use policy
To help advertisers comply with the Therapeutic Goods Advertising Code, we've provided a social media acceptable use policy that advertisers can use on their digital platforms

Advertising guidance for businesses involved with medicinal cannabis products
The focus of this guidance is to help you to understand how to promote your business and service without advertising medicinal cannabis products to the public, which is prohibited.

Advertising guidance for providers of disease education activities
This guidance is to assist providers of disease education activities (including sponsors, health professionals, pharmacies, peak organisations and community educators) to ensure that disease education activities do not inadvertently become advertisements for therapeutic goods

Advertising guidance for businesses involved with stem cells and other human cell or tissue (HCT) products
This guidance is to assist providers of stem cells and other human cell and tissue (HCT) products regulated as biologicals (including sponsors, manufacturers, importers, pharmacists, health professionals and marketers) in complying with the therapeutic goods advertising restrictions

Fact sheets

Complying with the new Advertising Code: Tips to help advertisers

Complying with the new Advertising Code: Tips to help pharmacists

Advertising health products: Rules about safety claims in advertising

Advertising therapeutic goods: Natural claims on medicines and medical devices: naturally compelling?