FOI release

Inconsistent Application of Regulation 62(3) Across Injectable Medicines

Some or all of the information requested was not provided because we didn't hold it.

Case reference FOI2026/00452

Received 24 April 2026

Published 11 June 2026

Request

I am writing to request information under the Freedom of Information Act 2000. Background In response to my earlier FOI request (FOI2026/00344), the MHRA confirmed that injectable hydroxocobalamin and cyanocobalamin are classified as prescription-only medicines (POM) under Regulation 62(3) of the Human Medicines Regulations 2012, on the basis that products intended for parenteral administration are unsuitable for reclassification due to the heightened risks and complexities associated with this route of administration, making medical supervision necessary. However, a number of injectable medicines are routinely self-administered by patients at home without direct medical supervision at the point of administration, following initial training. These include but are not limited to: Insulin Subcutaneous methotrexate Injectable fertility treatments (for example gonadotrophins) Biologic medicines for conditions including rheumatoid arthritis and Crohn's disease (for example adalimumab, etanercept) Growth hormone preparations requiring reconstitution from vials Several of these products require considerably greater technical skill to prepare and administer than a simple ampoule injection, yet home self-administration is standard clinical practice for them. This appears to create an inconsistency in the application of Regulation 62(3). The regulation as cited treats parenteral administration as a uniform category requiring medical supervision. Actual regulatory and clinical practice does not treat it as uniform. Please provide: Any internal guidance, policy documents, or assessments held by the MHRA that explain how Regulation 62(3) is applied differentially across injectable medicines, including the criteria used to determine when home self-administration is considered acceptable for a POM injectable product. Any internal assessments, advice, or correspondence held by the MHRA that specifically addresses the safety profile of injectable hydroxocobalamin in the context of home self-administration, including any assessment of its therapeutic index, known toxicity ceiling, or adverse event profile compared with other injectable medicines routinely self-administered at home. Any communications held by the MHRA between its licensing, classification, or policy teams regarding whether the current POM classification of injectable hydroxocobalamin remains proportionate given its established safety profile, from January 2010 to the present date. Any risk assessments or benefit-harm analyses conducted by the MHRA comparing the risks of maintaining the current POM classification of injectable B12 (including the risk of patients sourcing unregulated alternatives) against the risks of reclassification to pharmacy or supervised pharmacy status. The criteria the MHRA applies when determining that a parenteral medicine may be suitable for patient self-administration at home, and whether injectable hydroxocobalamin has ever been assessed against those criteria.

Response

See attached

Documents

• FOI2026_00452 (redacted).pdf (1.9 MB)

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