Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to support the reclassification of medicines with long histories of safe prescribing to be sold over the counter.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is an executive agency of the Department and regulates medicine, medical devices, and blood components for transfusion in the United Kingdom, with responsibility for ensuring that medicines meet appropriate standards of safety, quality, and efficacy.

A Reclassification Alliance was established between industry, the MHRA, and the Department to explore opportunities for improving the reclassification of medicines in the UK. The MHRA has developed an updated reclassification procedure and in April 2024 published updated reclassification guidance. In November 2024, the MHRA also held a reclassification webinar for industry, which focused on the updated procedure and reclassification guidance. In addition, earlier this year, the Government published a list of conditions and categories identified for potential reclassification.

The Government is committed to ensuring that medicines are available to patients in the most convenient and accessible manner, provided that it is safe to do so. The reclassification of medicines from prescription-only to over-the-counter status is a vital part of this commitment. The reclassification agenda aligns with broader Government initiatives, including the NHS 10-Year Health Plan and the Health Sector Strategy, which aim to improve patient access and reduce pressure on general practice through enhanced pharmacy services.

The MHRA welcomes discussions with industry as to how we can assess more applications, especially of novel types, which will aid patient choice in the UK.