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Tech Alert: Outcomes of RASML consultations for registered medicines: Menthol; methyl salicylate; melatonin

30 Nov 2021 10:54 AM | Anonymous member (Administrator)

Today's Technical Alert provides information on the Required Advisory Statements for Medicine Labels (RASML) consultation outcomes for menthol; methyl salicylate; and melatonin. RASML statements become adopted by the Medicines Advisory Statements Specification (MASS).

These changes to RASML /MASS largely affect registered complementary medicines and are not yet updated to reflect the changes, but are expected to be updated in late 2021 or early 2022.

A transition period of 18 months from commencement will allow for any existing medicines to have their labelling updated. More information is included in this technical alert including context and a comparison between the requirements and those currently outlined for menthol and methyl salicylate in listed medicines in the Permissible Ingredients Determination.

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