Required Advisory Statements for Medicine Labels (RASML)
About the RASML
The Therapeutic Goods Order No. 69 - General requirements for labels for medicines requires the labels of some over-the-counter and complementary medicines to contain particular warning statements ('advisory statements') about specific risks related to use of the medicines.
These advisory statements are set out in the Required Advisory Statements for Medicine Labels (RASML), which is registered on the Federal Register of Legislative Instruments as schedules to the Specification titled Medicines Advisory Statements Specification 2016.
The Medicines Advisory Statements Specification 2016 ('the Specification') came into effect on 1 January 2016.
The Specification includes two versions of the RASML, as Schedule 1 and Schedule 2 to the Specification, respectively. This is intended to allow for a transition period for sponsors to comply with new label requirements in Schedule 2 that will come into effect on 1 July 2017.
RASML No. 2 (Schedule 1)
The current edition, The current edition, RASML No. 2. , came into effect on 1 January 2016.
RASML No. 2 will remain in effect untill 1 July 2017.
RASML No. 3 (Schedule 2)
RASML No. 3 will come into effect on 1 July 2017.
Summary of new label requirements in RASML No. 3
RASML No. 3 will include the new and amended statements that were the subject of either public consultation, or a new Condition of Listing, between January 2014 and October 2015, as follows:
- Consultation: cimetidine, famotidine, nizatidine and ranitidine: corrected advisory statement for medicines: 1 October 2015
- Consultation: Metoclopramide: proposed advisory statements for medicines: 7 April 2015 (Submissions and TGA response 13 May 2015)
- Consultation: Non-steroidal anti-inflammatory drugs [NSAIDs] (diclofenac, flurbiprofen, ibuprofen, ketoprofen, mefenamic acid and naproxen) for oral use: proposed additional advisory statements for medicines: 18 March 2015 (Submissions and TGA response 11 June 2015)
- Consultation: Esomeprazole: proposed advisory statements for medicines: 10 October 2014 (Submissions and TGA response 2 December 2014)
- Consultation: OTC nasal decongestant preparations for topical use: proposed advisory statements for medicines: 5 May 2014 (Submissions and TGA response 9 September 2014)
- Consultation: OTC cough medicines for oral use: proposed advisory statements for medicines: 5 May 2014 (Submissions and TGA response 9 September 2014)
- Consultation: Chloramphenicol, propamidine, dibromopropamidine and sulfacetamide for ophthalmic use: proposed advisory statements for medicines: 10 January 2014 (Submissions and TGA response 4 March 2014)
- Condition of Listing for Euphausia superba oil (Krill Oil) in Listed Medicines: since June 2015, this Condition of Listing has required that all listed medicines containing this ingredient are labelled with the warning 'Contains crustacean shellfish' or 'Derived from seafood' (as published in the TGA eBusiness Services News on 29 April 2015).
For further details, see also: Explanatory Statement on the Amendment Specification
We recommend that sponsors take steps to amend any labels affected by the new requirements in RASML No. 3 immediately in order to ensure that they will be compliant by 1 July 2017. This is the purpose of the 18 month transition period in which both RASML No.2 and No.3 are published.
How to use RASML
Updating the RASML
The RASML will be periodically updated to include new and amended advisory statements.
- Archived versions of the RASML
- Consultation: corrections and minor changes to the RASML (closed 10 April 2015)