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Required Advisory Statements for Medicine Labels (RASML)

Learn about Required Advisory Statements for Medicine Labels (RASML).

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Australian labelling requirements for non-prescription medicines (Therapeutic Goods Order No. 92) require some over-the-counter (OTC) and complementary medicine labels to contain particular warning statements ('advisory statements') about specific risks related to use of the medicines.

Advisory statements are set out in the 'Required Advisory Statements for Medicine Labels' (RASML). The most recent version of 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').

Please note that RASML does not comprehensively cover all registered non-prescription medicines. Medicines may fall outside RASML where there is no entry for the active ingredient, such as for ingredients that have been recently down-scheduled from prescription-only to OTC availability, or where they do not meet the scope or conditions specified in existing entries. In these circumstances, warning statements for the medicine may be proposed and considered at the time of registration, with reference to existing medicines where necessary.

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:

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:

How to use RASML

Updating RASML

The advisory statements in RASML and the conditions of their application to particular medicines need to be updated from time to time. Changes can include:

  • addition of a new requirement
  • amendment to the wording of an existing advisory statement
  • removal of a requirement.

When RASML needs to be updated

Identification of the need to update RASML occurs in various circumstances, including those listed below. 

  • The need for an advisory statement may be identified during evaluation of a medicine for inclusion in the ARTG.
  • New information may become available after inclusion of a medicine in the ARTG.
  • A change to the scheduling of existing medicines that results in greater availability (e.g. from 'Prescription Only Medicine' [S4] to 'Pharmacist Only Medicine' [S3]) may result in the need for a new advisory statement.
  • Problems with the wording of an existing advisory statement may be identified, and improved wording proposed.
  • New information may warrant the deletion of a required warning.

Public consultation

Proposals to update RASML are published on the TGA consultation hub and any interested person or party can provide comment. In some cases, the TGA may specifically invite peak bodies representing consumers, industry and the professions, as well as relevant TGA expert committees, to provide comment.

  • The TGA considers additions or changes to RASML as the need arises and may seek advice from an appropriate expert advisory committee if necessary. 
  • After consideration by the TGA, proposals are published on the TGA website, with request for submissions from interested parties. The information published on the TGA website includes reasons why the advisory statement(s) or changes to statements are considered necessary and any relevant background information.
  • The period for comments is 6 weeks from the date of publication on the TGA website, unless otherwise specified in the website information.

Determination

The TGA determines the final outcome of the proposal, after taking into account advice sought from any expert committee and all comments received in the public consultation. All decisions (including a decision not to change) are published on the TGA website, together with reasons for the decision.

Implementation

New and/or amended label advisory statements will be included in the next update to RASML, which is updated from time to time as needed.

Transition period for compliance with new editions of RASML

The new edition of RASML will provide for a transition period for existing products to comply with new or amended advisory statements. The transition period will normally be 18 months from the date of publication on the Federal Register of Legislation. For new product registrations immediate compliance is required, and where labelling is otherwise being updated compliance would usually be expected.

Historical information

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