Australia's TGA consults on consumer advertising

5 June 2018 - Deborah Wilkes

Australia's Therapeutic Goods Administration (TGA) is running a public consultation on a proposal to extend the list of Schedule 3 substances that can be advertised to consumers.

The move follows the publication in January 2018 of a revised Scheduling Policy Framework. The new policy intent for advertising of Schedule 3 non-prescription medicines, according to the TGA, is that they can be advertised to consumers unless it has been determined that this is not appropriate (click here to read the News story).

Schedule 3 non-prescription medicines – also known as pharmacist-only medicines – can only be advertised to Australians if all the ingredients are substances listed in Appendix H of the Poisons Standard.

Currently, only 19 of the 85 substances listed in Schedule 3 are included in Appendix H. The 19 include diclofenac, esomeprazole, fluconazole, ibuprofen, omeprazole, pantoprazole, rabeprazole and ulipristal.

Twenty-four new additions

The TGA is consulting on adding a further 24 Schedule 3 substances to Appendix H, including chloramphenicol, famciclovir, levonorgestrel, naloxone, salbutamol and triamcinolone.

However, another 42 Schedule 3 substances – including cimetidine, orlistat and pseudoephedrine – would be excluded from Appendix H.

The TGA pointed out that existing Schedule 3 substances would be considered in bulk and specific applications from companies would not be required.

The consultation closes on 9 July 2018, and the TGA expects the process to be "largely complete by the end of 2018".

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