FOI release

FOI - Prescription-only status of cyanocobalamin/hydroxocobalamin injection ampoules

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 FOI2026/00344

Received 26 March 2026

Published 11 May 2026

Request

I am writing to request information under the Freedom of Information Act 2000. Cyanocobalamin and hydroxocobalamin injection ampoules are available for purchase without a prescription in several EU member states, including France and Germany. In the United Kingdom, these products are classified as prescription-only medicines (POM). Please provide: The date on which hydroxocobalamin and/or cyanocobalamin injection ampoules were classified as prescription-only medicines in the UK, and the regulatory instrument or process by which this classification was established. Any internal assessments, advice, or correspondence held by the MHRA that informed or supported the decision to classify these products as prescription-only rather than pharmacy (P) or general sale medicines. Any communications between the MHRA and the Department of Health and Social Care, NHS England, or NICE regarding the prescription-only classification of injectable B12 products, from January 2000 to the present date.

Response

See attached

Documents

• FOI2026_00344 (redacted).pdf (1.7 MB)

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