Required advisory statements for medicine labels (RASML): proposals to amend the RASML

The Required advisory statements for medicine labels (RASML):

• sets out the advisory statements that are required to be included on the labels of specified medicines; and
• is registered on the Federal Register of Legislation - external site as the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 - external site ('the Specification') under subsection 3(5A) of the Therapeutic Goods Act 1989

The advisory statements required by the RASML are designed to inform consumers about specific risks related to the use of medicines that have been identified via pharmacovigilance activities, testing, adverse event reports or other scientific or clinical information.

Updating the RASML

The advisory statements in the RASML and the conditions of their application to particular medicines need to be updated from time to time. Changes can include addition of new requirement(s), amendment to the wording of existing requirement(s), or removal of the requirement for advisory statement(s).

Examples of circumstances that can result in the need for changes to the RASML include the following:

• The need to have an advisory statement on the label for safe use of the medicine may been identified by the medicine sponsor or by the TGA during the process of registration or listing of the medicine on the ARTG.
• A new advisory statement may be considered necessary to ensure the safe use of existing goods because new information has become available after inclusion on the ARTG.
• A new advisory statement may be required as a consequence of 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]).
• Problems with the wording of an existing advisory statement may be identified, and improved wording proposed.

Proposals are published on the TGA web site and any interested person/party can provide comment. In some cases, peak bodies representing consumers, industry and the professions, as well as relevant TGA expert committees, may be specifically invited to comment.

Process for RASML updates that do not involve rescheduling of a substance

The process for change is as follows:

Proposal to amend the RASML

Proposals for change to the RASML can be made by any interested party.

• The form Proposal to Amend the Required Advisory Statements for Medicine Labels should be completed and forwarded by email to the RASML Document Manager.
• Applicants should note that all information provided with this form will be made available to the public.

Consideration and consultation

Proposals are considered by the relevant TGA area of responsibility (the 'TGA Regulator'). Consultation is an important part of this consideration.

• The TGA Regulator may seek advice from the appropriate expert advisory committee such as the Advisory Committee on Non-prescription Medicines or the Advisory Committee on Complementary Medicines. Where a proposed change affects goods from more than one category of medicines, a coordinated approach is adopted within the TGA to ensure the needs of all parties are taken into account.
• After consideration by the TGA Regulator and/or Expert Committee(s), proposals are published on the TGA web site, with request for submissions from interested parties. The information package published on the TGA web site typically includes:
  • the proposed label advisory statement;
  • the substance(s) and/or class of substance to which it is proposed to apply;
  • the conditions under which the statement is proposed to apply (e.g. SUSMP schedule, any cut off concentration, or any particular indication);
  • the reason why the advisory statement is considered necessary;
  • the proposed transition period (as part of the consultation on the draft RASML document);
  • contact details for responses and/or further information;
  • cut off date for responses to be submitted; and
  • any other relevant information.
• The period for comments is 4 weeks from the date of publication on the TGA web site, unless otherwise specified in the web site information.

Under normal circumstances the process should not take more than 14 months from receipt of a proposal to publication of the updated RASML (as part of the annual update to the Medicines Advisory Statements Specification) on the FRL.

The TGA has separated the process of consulting on individual proposed advisory statements from the process of publishing each new edition of the RASML. This separation of the two processes is intended to ensure that the RASML can be regularly updated in a timely manner in the future (see Consultations & Reviews for details of current and closed consultations).

Determination

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

Implementation

Each new or amended label advisory statement will be included in the next scheduled update to the RASML. The draft of each new edition of the RASML will be made available annually on the TGA website for consultation before publication on the FRL (as a new schedule to the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 - external site).

Proposals to update the RASML that involve rescheduling of a substance

Proposal to amend the RASML

The TGA uses the existing Scheduling Processes where advisory statements are required as part of the process of changing the scheduling of a substance in the Poisons Standard.

Consideration and consultation

Interested parties have the opportunity to comment on proposed statements and their application to particular substances through the scheduling process. Therefore, unless the relevant TGA Regulator proposes amendments to the wording of the statement that had been published as part of the scheduling decision, a separate consultation phase is not generally required in these cases.

Determination and implementation

Changes decided by the relevant TGA Delegate will be published on the TGA's web site and implemented as outlined above for non-scheduling related changes.

Publication of decisions to amend the RASML requirements

Each decision to make a change to the RASML (including the text of the change), or not to change the RASML, is published on the TGA web site together with reasons for the decision.

The draft of each new edition of the RASML will be made available annually on the TGA website for consultation before publication on the FRL (as part of a new version of the Therapeutic Goods (Medicines Advisory Statements) Specification 2019 - external site).

Transition period for compliance with new editions of the RASML

Each new edition of the RASML will typically be included as 'Schedule 2' in the new version of the Specification. The date of commencement of the new 'Schedule 2' allows for a transition period for compliance with the new or amended advisory statements. The transition period will normally be 12 months from the date of publication on the FRL.

Process in cases of disagreement with a proposed amendment to the RASML

Parties who disagree with a proposed statement can make a submission within the consultation timeframe, stating the reasons for concern. This will be taken into consideration before any decision is made.

If stakeholder(s) subsequently have new information that has not been considered in the original proposal they can provide further proposal for consideration. This goes through the same process as a new proposal. There should normally be sufficient time and opportunity for reconsideration and/or confirmation of each individual change, particularly as the final draft RASML document will be provided for consultation on the TGA website before publication, and because of the 12-month transition period for new requirements.