The New Advertising Environment & Your Compliance Liabilities

The New Advertising Environment & Your Compliance Liabilities

A new advertising compliance environment is at your door, changing your obligations and liabilities when creating and/or placing therapeutic goods ads to consumers.

Involved in over-the-counter medicines, complementary medicines or devices advertising to consumers;

Mandatory pre-approvals were independent compliance checks by Therapeutic Goods Advertising Code (TGAC) experts, that helped advertisers:

  • manage their compliance obligations
  • reduce the compliance due diligence burden for publishers
  • minimise the publication of noncompliant ads

An estimated 60-70% of ads submitted for mandatory pre-approvals to CHP Australia’s Advertising Services Office required some form of compliance amendment.

Advertisers and those who “cause” advertising are legally responsible for compliance, and vulnerable to TGA noncompliance penalties, including fines up to $10 million and criminal prosecution

Noncompliance risks not only heavy fines and sanctions, but also:

  • Brand and reputational damage
  • Jeopardising creative and financial investments made to develop a brand
  • Opportunity loss and creative costs of relaunching ad campaigns
  • Administrative and legal costs managing complaints and noncompliance issues

Given the challenges of the new compliance environment, those involved in therapeutic goods ads should reassess their compliance obligations, capabilities, and liabilities.

Advertisers are expected to not only understand what the compliance requirements are, but also how to appropriately apply them to their advertising.

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

  • Is the advertising ethical?
  • Does the ad promote the safe and proper use of the product?
  • Is the ad consistent with current public health campaigns?
  • Does the advertising create unrealistic expectations?
  • Are all the claims, presentations, representations, and comparisons valid, substantiated, balanced, and not likely to mislead?
  • Is the ad 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 all the required mandatory statements been included correctly?
  • Has the ad complied with the specific requirements in relation to:
  • Scientific or clinical representations?
  • Endorsements, testimonials or incentives?
  • Advertising to children?
  • Restricted or prohibited representations?
  • etc

The TGAC is a complex, living document, with hundreds of pages of TGA guidance to assist advertisers with its more nuanced elements.

Without the safety net of mandatory pre-approvals, are you and your business be equipped to confidently manage your compliance obligations?

Use of an independent compliance service provided by dedicated TGAC experts, like AdCheck, is an easy and effective way advertisers, agencies, publishers and broadcasters can minimise the risk of noncompliance.

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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