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

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 menthol 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 8 submissions. All submissions supported (one ‘tentatively’) the proposed RASML entries. One respondent noted that it may be difficult to fit additional warnings on labelling for some smaller products.

One respondent suggested minor changes to the order of the warnings. While RASML does not mandate a particular order for inclusion of warnings on the label, the order will be revised as suggested, to better indicate how the warnings could most appropriately be included on the label.

Two respondents 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 include the proposed entries, with minor changes to the order of the warning statements as shown here, 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.