Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Methyl salicylate

Results updated 16 Nov 2021

Introduction

We asked for comments from interested parties on proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing methyl salicylate for dermal use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML).

Summary and discussion of responses

The TGA would like to thank those who responded to the consultation. We received 6 submissions. Two submissions considered that the proposed warning of “If irritation develops, discontinue use” should only apply to medicines containing more than 1 per cent of methyl salicylate, consistent with the Permissible Ingredients Determination. One respondent noted that it may be difficult to fit additional warnings on labelling for some smaller products. Submissions were otherwise supportive (one ‘tentatively’) of the proposed warnings.

The TGA had considered it unnecessary to exclude medicines containing 1 per cent or less of methyl salicylate from requiring the irritation warning given an absence of relevant medicines (one grandfathered product appeared to no longer be supplied). Nevertheless, for consistency with the Permissible Ingredients Determination, the proposed RASML entry will be amended so that the irritation warning is only required for preparations containing more than 1% methyl salicylate.

One respondent suggested fee relief for sponsors for mandatory changes and longer permitted timeframes for implementation of new warnings. The TGA considers that existing fees and implementation timeframes for labelling updates are appropriate, noting that extensions, via temporary exemption, may be granted in extenuating circumstances.

In response to concerns regarding regulatory duplication with RASML and the Permissible Ingredients Determination, there is no duplication as RASML applies to registered medicines whereas the Permissible Ingredients Determination applies to listed medicines. (In rare cases, but not relevant here, RASML may apply to listed medicines where allowance for listing is dependent on exclusion from a schedule to the Poisons Standard, which is dependent on the inclusion of a RASML warning.)

Outcome

The TGA will amend the proposed entry to exclude the irritation warning for medicines containing 1 per cent or less of methyl salicylate, as shown here, and will include the entries in the next update of the RASML, to occur in late 2021 or early 2022. A transition period of 18 months from commencement of the new RASML will allow for existing medicines that do not comply with new requirements to have their labelling updated.

Published responses

View submitted responses where consent has been given to publish the response.