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. 5
RASML No. 5, included as Schedule 1 to the Medicines Advisory Statements Specification 2019 ('the 2019 Specification'), came into full effect on 1 September 2020 after a transition period of 18 months. Labels must comply, as a minimum, with the advisory statement requirements specified in RASML No. 5 during the transition period for RASML No. 6, which ends on 31 June 2023.
RASML No. 6
RASML No. 6 was published on 1 January 2022 as Schedule 1 to the 2021 Specification and comes into full effect on 1 July 2023 after the 18-month transition period. During the transition period, labels may comply with either RASML No. 5 or RASML No. 6.
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:
Transition period
We recommend that sponsors take steps to amend any labels affected by the new requirements in RASML No. 6 immediately in order to ensure that they will be compliant by 1 July 2023. This is the purpose of the 18 month transition period in which either RASML No. 5 or No. 6 may be applied.
How to use RASML
Updating the RASML
The RASML will continue to be periodically updated to include new and amended advisory statements.