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').
RASML No. 6
RASML No. 6 was published on 1 January 2022 as Schedule 1 to the 2021 Specification and came into full effect on 1 July 2023 after the 18-month transition period.
RASML No. 6 includes the new and amended statements that were the subject of public consultation between April and September 2021, as follows:
- Consultation: Proposed minor changes to Required Advisory Statements for Medicine Labels (RASML): Chlorhexidine, hydrocortisone, ibuprofen 6 August 2021 (Outcome published 17 November).
- Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Lidocaine (lignocaine) 6 April 2021 (Outcome published 16 November).
- Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Melatonin 6 August 2021 (Outcome published 16 November).
- Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Menthol 6 April 2021 (Outcome published 16 November).
- Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Methyl salicylate 6 April 2021 (Outcome published 16 November).
- Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Mometasone 6 August 2021 (Outcome published 16 November).
- Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines 6 April 2021 (Outcome published 16 November).
- Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Triptans 6 August 2021 (Outcome published 17 November).
RASML No. 6 also includes the removal of codeine entries (no longer available as OTC medicines) and correction to Entry 2 for pyridoxine (to refer to vitamin B6).
For further details, see also:
- Medicines Advisory Statements Specification updates
- Therapeutic Goods (Medicines Advisory Statements) Specification 2021