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Tech Alert: Proposed Changes to RASML – Melatonin

09 Aug 2021 12:36 PM | Anonymous member (Administrator)

The TGA have announced a consultation on proposed changes to advisory statements for Registered Complementary Medicines containing melatonin, closing on 17 September 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 melatonin for oral use, for inclusion in the Required Advisory Statements for Medicine labels (RASML).

Please note: The proposed changes will apply only in RASML to registered medicines; there are currently no RASML warning statements for melatonin. Melatonin is in included in Schedule 3 of the Poisons Standard and therefore is not eligible for inclusion in listed medicines and not currently included in the Permissible Ingredients Determination (certain homeopathic preparations may be exempt from listing requirements).

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

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