At a glance, navigating the TGAC without mandatory pre-approvals

On 30 June, the mandatory pre-approval of therapeutic goods advertising to consumers will end, and those involved in therapeutic goods advertising will need to adapt to the new compliance environment.

To help advertisers navigate this change, CHP Australia has compiled this brief overview of the compliance environment, some of its many complexities, and how you could minimise your risk of noncompliance.

The Basics

  • From July 1, companies that create and/or place ads will still have the legal responsibility to ensure their ads are compliant, but without the compliance safety net of mandatory pre-approvals.
  • All therapeutic goods advertising to consumers must comply with TGA advertising regulations and the Therapeutic Goods Advertising Code (TGAC).
  • Both advertisers and those who “cause” the advertising are legally responsible for the advertising’s compliance.
  • Parties considered to “cause” advertising include, among others, retailers, agencies, publishers and broadcasters.
  • Strengthened TGA investigating powers, and increased noncompliance penalties are in place and enforceable.
  • Noncompliance risks not only heavy fines, but also brand and reputational damage.
  • Should an advertisement be found to be in breach, an advertiser’s “attitude towards compliance” is a factor the TGA considers when determining the appropriate compliance and enforcement tools.

The Code

The Therapeutic Goods Advertising Code (TGAC) is a complex, living document and to assist advertisers with the more complex elements, the TGA has published hundreds of pages of guidance.

Advertisers need to be confident they not only understand what the compliance requirements are, but also how to appropriately apply them to advertising.

So, before advertising here are some of the questions you will need to ask yourself:

  • Is your advertising ethical?
  • Are you promoting the safe and proper use of the product?
  • Is your advertising consistent with current public health campaigns?
  • Does your advertising create unrealistic expectations?
  • Are all the claims, presentations, representations, and comparisons valid, substantiated, balanced, and not likely to mislead?
  • Is your advertisement likely to lead to people delaying necessary medical attention or delaying the use of, or failing to use, treatment prescribed by a medical practitioner?
  • Do you know all the specific mandatory statements that are required depending on the therapeutic good or claim being advertised?
  • Have you correctly included all required mandatory statements?
  • Have you complied with the specific requirements in relation to:
    • Scientific or clinical representations?
    • Endorsements, testimonials or incentives?
    • Advertising to children?
    • Restricted or prohibited representations?
    • etc

An estimated 60-70% of ads submitted for mandatory pre-approvals to CHP Australia’s Advertising Services Office required some form of compliance amendment. When mandatory pre-approvals end on 30 June, will your business be equipped to confidently manage your compliance obligations?

AdChecks are performed by the same CHP compliance experts who previously provided mandatory pre-approvals.

Don’t run the risk – Submit for AdCheck

For more information about the AdCheck service visit 

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