TGA Schedule 4 Advertising - IMPORTANT UPDATE FOR ADVERTISING YOUR RESULTS

update from tga.

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To ensure the consistent application of the legislation related to the advertising of therapeutic goods across all industry sectors, the Therapeutic Goods Administration (TGA) has updated our position on references (even in generalised terms) to cosmetic injectables in advertising.

As your members are aware, it is an offence against s42DL(10) and a breach of s42DLB(7) of the Therapeutic Goods Act 1989 (the Act) to advertise where the advertisement refers to substances, or products containing substances, included in Schedule 3, 4 or 8 (but not in Appendix H) to the current Poisons Standard.

The promotion of a health service as a means to obtain a prescription medicine is a form of advertising prescription medicines. Decisions about treatments that involve the use of prescription medicines should be made by a doctor in consultation with each individual patient. It is not legal to influence consumers about the use or supply of prescription medicines through advertising.

For the cosmetic industry this means that while the advertising of the service provided remains outside the jurisdiction of the Act, if such an advertisement refers to a schedule 4 substance or a product containing that substance (even in general terms such as wrinkle reducing injection') the advertisement will in almost all cases be considered an unlawful advertisement for therapeutic goods.

To support the consistent application of legislation related to the advertising of therapeutic goods across all industry sectors, on 18 December 2023. previously published guidance which included certain terms considered at the time to be acceptable was removed from our website.

These terms included anti-wrinkle injections' and 'dermal fillers'.

This is because these terms refer to (by drawing the audience's mind to) prescription only products. Alternatives to these references to support advertising of services remain availabie, for example:

“ our clinic can provide consultations on reducing the appearance of wrinkles “