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Advertising medicines: Requirements for pre-approval

13 May 2019

Advertisements for medicines require pre-approval before they can appear in specified media. As a result of changes to the Therapeutic Goods Act 1989 (the Act), this will no longer be required after 30 June 2020.

Current
advertising
pre‑approval
requirements
remain
unchanged
until
1 July 2020

What is 'specified media'?

The term 'specified media' represents traditional mass media channels including magazines, newspapers, television and radio broadcasts as well as cinematograph films, billboards, advertising on public transport and displays in shopping malls. It does not include the internet, email, pay television or other mediums covered in Regulation 5BA of the Therapeutic Goods Regulations 1990.

Assessing compliance

Until 1 July 2020, advertisements for medicines to appear in specified media will continue to require pre-approval under Regulation 5G of the Therapeutic Goods Regulations 1990. This includes being assessed for compliance with the Therapeutic Goods Advertising Code (No. 2) 2018 (the Code).

Advertisers using specified media should be aware that the Code took effect from 1 January 2019. Pre-approval applications lodged before then are assessed against the old Code:

  • For applications decided on or before 31 December 2018, compliance will be assessed against the Therapeutic Goods Advertising Code 2015.
  • For applications decided on or after 1 January 2019, compliance will be assessed against the Therapeutic Goods Advertising Code (No. 2) 2018.

Under section 42C of the Act, it is an offence to publish or broadcast an advertisement for therapeutic goods without pre-approval, up until 1 July 2020. Section 42C also addresses other offences relating to pre-approval, including an offence for publishing or broadcasting an advertisement that differs from the approved advertisement. The TGA may choose to issue an infringement notice to an advertiser that fails to comply with section 42C of the Act, once the TGA is satisfied that the advertiser is aware of the pre‑approval requirements.

Restricted representations

Restricted representations - any reference, expressly or by implication, to a serious disease, condition, ailment or defect - must be approved by the TGA before being used in any kind of advertising. This approval will still be required after 1 July 2020.

For advertisements that require pre-approval, the restricted representation approval is required before seeking pre-approval of the advertisement.

Complaints about advertisements

Complaints about the advertising of therapeutic goods to the public (including approved advertisements) should be lodged with the TGA. The TGA will assess any advertising complaints against the applicable version of the Therapeutic Goods Advertising Code.

Consequences for non-compliant advertising

Where a pre-approved advertisement is considered by the TGA to breach the advertising requirements in the Act and the Code, the TGA may consider:

  • varying any conditions on the advertisement approval under Regulation 5K
  • withdrawing the approval for the advertisement in accordance with Regulation 5L
  • issuing a direction to the advertiser under section 42DV of the Act to address non-compliant advertising and/or retract or correct the advertising.

The TGA may also issue the advertiser with a substantiation notice under section 42DR of the Act to establish whether particular claims made in the advertisement are verified.

Receiving an approval for an advertisement does not guarantee that the advertisement is fully compliant with the Act and the Code, as other people seeing the ad may interpret it in a way that the delegate did not foresee. Nor does it indemnify the approval holder from upheld complaints about the advertisement.

Further information

Please contact the TGA via tga.advertising@tga.gov.au or by calling 02 6232 8757.