FOI release

FOI Differential regulatory status of injectable B12 for human versus veterinary use

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 FOI2026/00332

Received 25 March 2026

Published 11 May 2026

Request

I am writing to request information under the Freedom of Information Act 2000. Injectable hydroxocobalamin and cyanocobalamin products formulated for veterinary use are available in the United Kingdom without a prescription, including via online veterinary pharmacies and agricultural suppliers. Injectable hydroxocobalamin formulated for human use is classified as a prescription-only medicine (POM). Please provide: Any internal assessments, advice, or correspondence held by the MHRA that addresses the differential regulatory treatment of injectable B12 products for human versus veterinary use, including any consideration of whether this differential creates a patient safety risk through off-label sourcing of veterinary products by human patients. Any evidence that the MHRA is aware of patients sourcing veterinary injectable B12 products for self-administration, and any action taken or considered in response. Any communications between the MHRA and the Veterinary Medicines Directorate (VMD) regarding the classification of injectable B12 products and the implications of the difference in human and veterinary regulatory status.

Response

See attached

Documents

• FOI2026_00332 (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.