FOI release

Melatonin POM to P reclassification and prior CHM advice provided

This request was refused in full, so we didn't provide the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2025/01334

Received 29 December 2025

Published 6 February 2026

Request

The CHM Annual Report for 2024 (see attached pages 13-14) summarises briefly several reclassification applications which CHM advised on. The CHM has considered a POM to P reclassification of melatonin indicated in adults for short-term treatment of jet lag. We would like to request further details including the proposed Pharmacy conditions requested e.g. product format and strength, indication, age limit, posology including maximum daily dose and maximum pack size. We would also like to request details of the CHM advice given and any requests for further information shared with the MHRA reclassification group and applicant.

Response

See attached

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