Advertisers are reminded the Therapeutic Goods Advertising Code 2018 (TGAC) was recently amended by the Therapeutic Goods Amendment (Therapeutic Goods Advertising Code) Instrument 2019. The amendments came into effect on 30 July 2019. This is particularly important given the TGA continues to crack down on non-compliant advertising.
What should you look out for?
Advertising prescription only medicines or therapeutic goods that are not listed or registered on the Australian Register of Therapeutic Goods (ARTG) are some of the most common offences.
Indeed, on 10 September 2019:
- PharmaCare paid a fine of AU$12600 for advertising its 'Sambucol Cold & Flu Kids Liquid' product which had previously been cancelled from the ARTG (the reason for its cancellation from the ARTG was due to its initial application for inclusion on the ARTG being false or misleading).
- Redback SARMs paid fines in the amount of AU$15210 after the TGA issued six infringement notices for non-compliant advertising of prescription only medicines.
Other offences include advertising restricted or prohibited representations without approval or permission from the TGA.
Review your marketing material
In light of the recent amendments to the TGAC, we recommend advertisers review their marketing material to ensure compliance with the updated TGAC, particularly in relation to mandatory health warning statements.
The key amendments to the TGAC include:
- A change to the general rules of advertisements to clarify that, for the purposes of section 13, the test for whether there is a health warning for a medicine is limited to the inclusion of an ingredient listed in Part 1 or Part 2 of Schedule 1 (Medicine ingredients with specific health warnings).
- Clarification that the general rules of advertisements do not apply to advertisements for therapeutic goods containing only the name of the goods, a pack shot image of the goods or the price of the goods so long as no therapeutic claims are visible or implied.
- Clarification that advertisers may either use the indication or intended purpose as it is set out on the good's label or primary packaging, or, alternatively, modify the indication or intended purpose in a manner that does not change the meaning or intent of the indication or intended purpose, as it appears on the label or packaging.
- With respect to restricted representations, clarification that a serious form of a disease, condition, ailment or defect does not include pregnancy, other than pregnancy with a medical, obstetric or surgical condition.
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