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NHS: Drugs

Question for Department of Health and Social Care

UIN 183214, tabled on 24 October 2018

To ask the Secretary of State for Health and Social Care, whether all EU imported medicines approved by the NHS will remain approved on 30 March 2019 in the event that the UK leaves the EU without a deal.

Answered on

29 October 2018

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:

Named day
Named day questions only occur in the House of Commons. The MP tabling the question specifies the date on which they should receive an answer. MPs may not table more than five named day questions on a single day.