Required Advisory Statements for Medicine Labels (RASML)
About the RASML
Australian labelling requirements for non-prescription medicines (Therapeutic Goods Orders 69 and 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), which is registered on the Federal Register of Legislation (FRL) as schedules to the Specification titled Medicines Advisory Statements Specification 2017 ('the 2017 Specification').
The 2017 Specification includes two versions of the RASML, as Schedule 1 and Schedule 2 to the Specification, respectively. This is intended to allow for implementation of a new Schedule 1, starting 1 July 2017, as well as a transition period for sponsors to comply with new label requirements in Schedule 2 that will come into effect on 1 January 2019.
RASML No. 3 (Schedule 1)
The current edition, RASML No. 3, came into effect on 1 July 2017, as Schedule 1 to the 2017 Specification.
RASML No. 3 is identical to the document of the same name that was published on the FRL on 24 November 2015 as Schedule 2 to the Medicines Advisory Statements Specification 2016 (the previous Specification), apart from the removal of some requirements - including all requirements that applied solely to listed medicines - as previously advised (see Medicines advisory statements specification updates).
RASML No. 3 will remain in effect until 31 December 2018.
RASML No. 4 (Schedule 2)
RASML No. 4 will come into effect on 1 January 2019, as Schedule 2 to the 2017 Specification.
RASML No. 4 will include the new and amended statements that were the subject of public consultation between January 2016 and February 2017, as follows:
- Consultation: Non-steroidal anti-inflammatory drugs: proposed additional advisory statement 11 October 2016 (Submissions received and TGA response 13 February 2017)
- Consultation: Paracetamol and ibuprofen: advisory statements for medicines 11 October 2016 (Submissions received and TGA response 13 February 2017).
For further details, see also:
We recommend that sponsors take steps to amend any labels affected by the new requirements in RASML No. 4 immediately in order to ensure that they will be compliant by 1 January 2019. This is the purpose of the 18 month transition period in which both RASML No.3 and No.4 are published.
How to use RASML
Updating the RASML
The RASML will continue to be periodically updated to include new and amended advisory statements.