NHS: Drugs

Question

All medicines marketed in the United Kingdom are the subject of a marketing authorisation (MA) issued by either the European Commission (EC) or by the Medicines and Healthcare products Regulatory Agency (MHRA). In the event that the UK leaves the European Union without a deal, national MAs issued by the MHRA will remain valid regardless of the source of the product. MAs issued by the EC will cease to be valid but the UK is proposing that these authorisations will be converted into UK MAs in a so-called ‘grandfathering’ process that is currently part of a public consultation due to close on 1 November 2018. This would be an administrative process without reassessment of data as the MHRA has already been involved in the authorisation procedure.

Information on this procedure and the public consultation is available at the following links:

https://www.gov.uk/government/publications/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal/how-medicines-medical-devices-and-clinical-trials-would-be-regulated-if-theres-no-brexit-deal

https://consultations.dh.gov.uk/mhra/mhra-no-deal-contingency-legislation-for-the-regul/consultation/subpage.2018-09-19.0744149330/consultation/intro/user_uploads/consultation-annex--3.pdf