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Tech alert: Proposed Changes to RASML – Menthol and Methyl salicylate

06 Apr 2021 1:02 PM | Anonymous member (Administrator)

Two separate consultations are now open on proposed changes to required advisory statements for Registered complementary Medicines containing menthol and methyl salicylate, closing on 18 May 2021.

The TGA is seeking comment on the addition of proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing either menthol or methyl salicylate for dermal use, for inclusion in the Required Advisory Statements for Medicine labels (RASML).

The proposed changes apply only to registered medicines. requirements for menthol and methyl salicylate for listed medicines have already been implemented and are included in the Permissible Ingredients Determination.

Please read today’s technical alert for more information, including details on how to respond to the consultation(s).

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