Jane Hunt MP asked:
To ask the Secretary of State for Health and Social Care, if she will make it her policy to allow pharmacies to sell vitamin B12 injections.
The Rt Hon Andrew Stephenson CBE MP, Minister for Health and Secondary Care, responded:
To make a medicinal product available for sale in a pharmacy without a prescription, the product must be reclassified to pharmacy only status, also known as [P] medicines, by the Medicines and Healthcare products Regulatory Agency (MHRA).
This process is triggered by an application submitted to the MHRA by a company which holds a licence for the particular product. The MHRA will consider all submitted applications, with a decision to reclassify a medicine reached following a robust evaluation of the relevant data, including evidence of the safe use and supply of the product without a prescription. The company must also demonstrate in their application that the criteria specified in relevant legislation, such as the Human Medicines Regulations 2012, have been met.
In accordance with the Human Medicines Regulations 2012, regulation 62(3), Prescription-Only Medicine status will apply where: a direct or indirect danger exists to human health, even when used correctly, if used without medical supervision; there is frequently incorrect use, which could lead to direct or indirect danger to human health; further investigation of the activity or side-effects is required; or the product is normally prescribed for parenteral administration, via injection.
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 [P] medicines, as this would not be consistent with the legislation.
