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Therapeutic goods advertising: Update 29 October 2018

29 November 2018

TGA is reminding advertisers that the Therapeutic Goods Advertising Code 2018 (the 2018 Code) takes effect on 1 January 2019. We will continue to provide important information in the lead up to this change.

Compliance and enforcement discretion

We understand that advertisers are working hard to update systems and processes for implementing the new Code when it comes into force on 1 January 2019.

Stakeholders have asked us about the compliance actions the TGA may take in relation to advertising that complies with the 2015 Code but not the 2018 Code, particularly around the prominent display of mandatory information (such as health warnings), where the advertising remains in place after 1 January 2019 (including in stores) while advertisers are transitioning their advertisements.

We will take a pragmatic approach to our compliance activity during 2019 while following our complaints management process outlined in Complaints handling for the advertising of therapeutic goods.

When categorising advertising complaints we take into account a number of factors, including the risk posed to public health and safety. Where an advertiser publishes an ad that is not compliant with the 2018 Code, but would have been compliant with the 2015 Code, in particular in relation to requirements such as the mandatory statements used, scientific citations and testimonial disclosures, this is unlikely to pose a significant risk to public health.

In the event that a complaint is received during the first half of 2019 alleging non compliance of this type, the action taken will involve a reminder about the advertising obligations under the 2018 Code, but is unlikely (in the absence of other non-compliance) to attract more serious action. In the second half of 2019, where a complaint is received or a matter of non-compliance identified, we will seek information such as the process being applied to correct the advertising along with associated dates (including the date corrective action commenced) before determining whether to apply enforcement discretion.

For specified advertising that has been pre-approved under the Therapeutic Goods Regulations 1990 (the Regulations) on the basis of the 2015 Code, any complaints will be considered against the 2015 Code. For more information, see the changeover period.

Stakeholders have also enquired about early compliance with the 2018 Code prior to 1 January 2019.

Complaints about advertisements, other than those that have been pre-approved under the Regulations, which comply with the 2018 Code prior to 1 January 2019 will also be subject to the TGA position on compliance and enforcement discretion described above. Where an advertisement is fully compliant with the 2018 Code before 1 January 2019 (in particular compliant with the requirements for mandatory statements, scientific citations and testimonial disclosures), this is unlikely to pose a significant risk to public health.

Advertisers must ensure that either the 2015 Code or the 2018 Code is applied in full during the remainder of 2018; mixed compliance with both Codes is not acceptable. Advertisements that have been pre-approved under the Regulations on the basis of the 2015 Code must comply with that Code for the duration of the approval.

Therapeutic Goods Advertising Consultative Committee

On 18 October 2018 we held the first meeting of the Therapeutic Goods Advertising Consultative Committee (TGACC). The TGACC brings together members from the therapeutic goods industry, health care professionals, health organisations, media and advertisers and a varied group of consumer interests. The TGACC considered a range of issues including the 2018 Advertising Code, how we manage complaints, our education program and our performance measures.