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Required Advisory Statements for Medicine Labels (RASML)
- Medicines advisory statements specification updates
- Therapeutic Goods (Medicines Advisory Statements) Specification 2019
- Medicines Advisory Statements Specification 2017
- Therapeutic Goods Order No. 69 - General requirements for labels for medicines
- Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
- Process for updating the 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). The most recent version of the RASML (RASML No. 5) is registered on the Federal Register of Legislation (FRL) as Schedule 1 to the Specification titled Therapeutic Goods (Medicines Advisory Statements) Specification 2019 ('the 2019 Specification').
RASML No. 4
RASML No. 4, included as Schedule 2 to the Medicines Advisory Statements Specification 2017 ('the 2017 Specification'), came into effect on 1 January 2019 after a transition period of 18 months. Labels must comply, as a minimum, with the advisory statement requirements specified in RASML No. 4 during the transition period for RASML No. 5, which ends on 31 August 2020.
RASML No. 5
RASML No. 5 includes the new and amended statements that were the subject of public consultation between May and October 2018, as follows:
- Consultation: Sedating antihistamines: proposed additional advisory statements for medicines 24 May 2018 (Submissions received and TGA response 25 September 2018)
- Consultation: Benzocaine: proposed advisory statements for medicines 18 September 2018 (Submissions received and TGA response 14 January 2019)
- Consultation: Miconazole and fluconazole: proposed advisory statements for medicines 24 May 2018 (Submissions received and TGA response 14 September 2018)
RASML No. 5 also includes a new entry for fennel oil with the advisory statement "Keep out of reach of children", required for exclusion from Schedule 6 of the Poisons Standard. This advisory statement is included in RASML 5 in accordance with the entry for fennel oil included in Schedule 6 of the Poisons Standard on 1 June 2017 following public consultation.
For further details, see also:
We recommend that sponsors take steps to amend any labels affected by the new requirements in RASML No. 5 immediately in order to ensure that they will be compliant by 1 September 2020. This is the purpose of the 18 month transition period in which either RASML No.4 or No.5 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.