FOI release

FOI - Any reviews or reclassification applications for injectable B12

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

Case reference FOI2026/00346

Received 26 March 2026

Published 11 May 2026

Request

I am writing to request information under the Freedom of Information Act 2000. Please provide: Details of any applications received by the MHRA to reclassify hydroxocobalamin or cyanocobalamin injection ampoules from prescription-only medicine (POM) to pharmacy (P) status, including the date received, the applicant, and the outcome. If no such applications have been received, please confirm this in writing. Any horizon-scanning reviews, internal papers, or correspondence in which the MHRA has considered whether the current POM classification of injectable B12 remains appropriate, from January 2010 to the present date.

Response

See attached

Documents

• FOI2026_00346 (redacted).pdf (1.7 MB)

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.