Question to the Department of Health and Social Care:

Her Majesty's Government whether they plan to convert EU Regulation 658/2014 into UK law; and, if so, which UK body will assume the role of the European Medicines Agency for the setting and charging of fees to UK-based marketing authorisation holders.

The Medicines and Healthcare products Regulatory Agency sets and charges fees for marketing authorisations in the United Kingdom which are granted nationally and not approved centrally by the European Medicines Agency. The extent to which European Medicines Agency procedures will apply in the UK after we have exited the European Union will be subject to negotiations. The Government will ensure that the UK’s full approval regime is ready and operational as soon as the UK has formally departed the EU.