Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether his Department has made an assessment of the potential merits of allowing over-the-counter sales of vitamin B12 injections in the UK.

The Medicine and Healthcare products Regulatory Agency (MHRA) has authorised several medicines for use in different circumstances associated with vitamin B12 deficiency. The legal status assigned to medicines is dependent on an assessment of the product against the criteria for either Prescription Only Medicine status or General Sales List status, and the classification is determined via the marketing authorisation.

The criteria for classification are set out in Regulation 62 of the Human Medicines Regulations 2012 [SI 2012/2016 as amended], and Regulation 62(3) is clear that if the medicine is usually prescribed for parenteral administration, that is by injection, then the medicinal product must by law be classified as a prescription only medicine. Other aspects within Regulation 62 also apply in consideration of the most suitable legal status of vitamin B12 injection and its use in deficiency states.

Currently, United Kingdom law specifies that all products administered by injection must be subject to a prescription. The MHRA is therefore unable to reclassify the status of injections, including Vitamin B12, to medicines, as this would not be consistent with the legislation.