Therapeutic Goods Advertising Changes

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The following information has been provided by the TGA:

Advertising pre-approvals and the new code

We advise advertisers that the date on which an application for pre-approval is decided will determine the version of the code that the advertising must comply with.

Advertisements for medicines that are to appear in specified media require pre-approval under Regulation 5G of the Therapeutic Goods Regulations 1990. The requirement for pre-approval will continue until 1 July 2020.

If you intend to lodge an application for advertising pre-approval between now and 31 December 2018, you should keep this in mind and allow time for revisions if necessary.

If you are in doubt about the application of the 2018 Code to your advertising, please contact us at tga.advertising@tga.gov.au.

For pre-approval applications lodged prior to 1 January 2019 but decided on or after 1 January 2019, the decision will be made based on whether the advertisement complies with the 2018 Code.

Education activities

In addition to finalising a further two elearning modules, we are preparing a number of face to face and webinar information sessions over the next few months to educate advertisers on the 2018 Code and the advertising complaints handling framework. We are working with key industry bodies to deliver some of these activities.

To receive more information as it becomes available, please subscribe to the TGA website updates.

Advertising complaints handling framework

We have published information about the framework under which we receive and process advertising complaints. See – Complaints handling for the advertising of therapeutic goods to the Australian public.

Assessment of complaints

For complaints about pre-approved advertisements, compliance will be assessed against the version of the Code under which the advertisement was approved.

For all other advertisements, the version of the Code applied will depend on the date/s on which the advertisement aired or was published:

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