MHRA: the regulator for new medicines in Scotland

As the Medicines and Healthcare products Regulatory Agency (MHRA) is now the sole regulator of new medicines for use in NHSScotland, we are in the process of updating external facing and internal documents that make reference to the European Medicines Agency (EMA) regulatory process. One practical example of this programme of work is that the SMC Ultra-Orphan definition will be updated to make reference to the need for Great Britain orphan marketing authorisation from the MHRA rather than EMA orphan designation.

Please contact our team at his.smcsecretariat@nhs.scot if you have any queries.