Required Advisory Statements for Medicine Labels (RASML)

Australian labelling requirements for non-prescription medicines (Therapeutic Goods Order No. 92) require some over-the-counter and complementary medicine labels to contain particular warning statements ('advisory statements') about specific risks related to use of the medicines.

These advisory statements are set out in the TGA document 'Required Advisory Statements for Medicine Labels' (RASML). The most recent version of the RASML (RASML No. 6) is registered on the Federal Register of Legislation (FRL) as Schedule 1 to the Specification titled Therapeutic Goods (Medicines Advisory Statements) Specification 2021 ('the 2021 Specification').