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The Therapeutic Goods Advertising Code

27 April 2022

24 December 2021: The 2021 Advertising Code takes effect on 1 January 2022 and will be subject to a 6-month transition period until 30 June 2022 where both the 2018 and 2021 Advertising Codes will apply. The Advertising Code guidance has been updated to reflect changes to the Code. Further changes will be made to advertising education and guidance material over the coming months.

About the Therapeutic Goods Advertising Code

The Therapeutic Goods Advertising Code (the Code) is the cornerstone of the therapeutic goods advertising regulatory framework. It sets out minimum requirements for advertising therapeutic goods to the public.

This legislative instrument was made under section 42BAA of the Therapeutic Goods Act 1989 (the Act). There are criminal offences and civil penalties for advertising to the public in a manner that does not comply with the Code.

Advertising of therapeutic goods requires a higher ethical standard than may apply for advertising of ordinary consumer goods because consumers rely on therapeutic goods for their health.

It can be difficult for a consumer to determine the appropriateness of a therapeutic good for their particular circumstances, so it is important that promotional material is truthful, balanced and not misleading.

The Code exists to ensure that the advertising of therapeutic goods to the public is conducted in a manner that:

  • Promotes the safe and effective use of therapeutic goods by minimising misuse, overuse or underuse
  • Is ethical, does not mislead or deceive the consumer or create unrealistic expectations about product performance
  • Supports informed health care choices
  • Is not inconsistent with relevant current public health campaigns.

From 1 January 2022, advertisers are encouraged to ensure their advertisements comply with the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (2021 Advertising Code).

However, the Therapeutic Goods Advertising Code (No.2) 2018 (the 2018 Code) remains in-effect until 30 June 2022, and advertisers can choose to apply either the 2018 or 2021 Advertising Code until that date.

From 1 July 2022 all advertising will be assessed against the 2021 Advertising Code requirements.

This guidance should be read with the Code and its Explanatory Statement. It provides further information about the understanding, interpretation and application of the Code provisions.

Unless otherwise stated, the Code requirements apply to all elements of advertising (including both therapeutic claims and non-therapeutic claims) and all types of advertising of therapeutic goods to the public.

Advertisements in their entirety must comply with the requirements of the Code. Therefore, all claims, whether they are therapeutic claims or not, must be compliant.

Further information is available in the 'Guidance on applying the Advertising Code rules' on:

The 2021 Advertising Code

The 2018 Code has been reorganised and rewritten for the new 2021 Advertising Code to ensure the language and presentation meets contemporary government standards.

To assist with indexing and readability the Code is now divided into Parts (and Divisions where warranted) based on content. Parts commence with a simplified outline.

For the purposes of the Code, therapeutic goods have been divided into three broad categories: medicines, medical devices, or other therapeutic goods (OTGs) where needed.

What has changed in the Advertising Code?

For users familiar with the 2018 Advertising Code, a table of changes has been created to highlight the equivalent reference in the 2021 Advertising Code.

Frequently Asked Questions

We have received a number of questions about the Code interpretation and so we created an FAQs page which complements the guidance.

Please see the FAQs page for more details.

Reading the Advertising Code

In reading the Code provisions, note that the conjunctions 'and' and 'or' have different meanings:

  • The conjunction 'and' signifies that each paragraph set out in the provision applies
  • The conjunction 'or' puts each paragraph as an alternative such that only one of the paragraphs needs to be satisfied in order for the provision to apply
  • Where no conjunction is used, 'and' is implied unless the wording is clear that each itemised paragraph is an alternative.

Plurals and singular nouns

A reference to a noun that is singular is taken to include plural forms, for example 'medicine' also includes 'medicines'.

Person

A reference to 'person' in the Act, the Regulations or the Code includes individuals, organisations and corporate entities.

Generic information

Certain sections of the Code also apply to generic information. See Generic information.

All examples used in this guidance have been provided to demonstrate the application of the legislation.

They should not be taken to be a reference to any particular advertisement.