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

Overview

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed advisory statements for labels of over the counter (OTC) medicines containing melatonin, for inclusion in the Required Advisory Statements for Medicine Labels (RASML). The proposal to include advisory statements for melatonin-containing medicines in RASML follows recent down-scheduling of melatonin when supplied under specific conditions, from Schedule 4 to Schedule 3 of the Poisons Standard.

Why your views matter

The TGA is requesting comments that will help ensure that the proposed advisory statements are appropriate and support the quality use of the medicines.

Consultation paper

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

Providing feedback

We invite you to provide your feedback by clicking 'Make a submission' below and responding to the consultation question (by free text and/or file upload).

What happens next

All feedback will be considered after the consultation period ends and will be published on the TGA website if your consent is given.

Finalised advisory statements will be included in the next version of RASML, RASML No. 6. A transition period of 18 months from commencement of the new RASML is provided to allow for existing medicines that do not already comply with new requirements to have their labelling updated.