The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for reviewing the reclassification of the legal status of a medicinal product from prescription only to over-the-counter supply. An assessment of the suitability of a medicinal product for pharmacy or general sale list sale or supply usually follows an application from a marketing authorisation holder. Any application to change the legal status of a particular medicine will be considered carefully against the criteria in European and United Kingdom legislation. Patient safety remains the prime consideration and any application would be required to demonstrate its safety in use and that relevant patient and professional education issues had been addressed adequately.
The MHRA has not considered the reclassification of products containing botulinum type A neurotoxin, such as Botox.