Government publishes guidance on regulation of medicines and clinical trials in case of a no-deal Brexit

Guidance on how medicines, medical devices, and clinical trials will be regulated if the UK leaves the EU with no withdrawal agreement has been .

In a ‘no-deal’ Brexit, the UK’s participation in the European regulatory network would cease, and the Medicines and Healthcare products Regulatory Agency (MHRA) would take on the functions currently undertaken by the EU for medicines on the UK market. This would require changes to UK law via the Human Medicines Regulations 2012.

The MHRA is planning a public consultation on some of the major proposed legislative changes.

The UK would recognise CE-marked medical devices approved for the EU market. If this were to change in the future, adequate time would be provided for businesses to implement any new requirements, the government said.

The 2004 regulations for clinical trials will remain in force, modified using powers under the EU (Withdrawal) Act to ensure they still work in the UK after exit.

New EU clinical trials regulations (CTR) that are being developed will not be in force in the EU when the UK exits the EU, and so will not be incorporated into UK law on ‘exit day’ under the terms of Act.

But the government said the UK “will align where possible with the CTR without delay” when the regulations come into force in the EU.

Citation: The Salvadore DOI: 10.1211/PJ.2018.20205465

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Injectable Drugs Guide

    A user friendly, single point of reference for healthcare professionals in the safe and effective administration of injectable medicines.

  • BNF for Children (BNFC) 2018-2019

    The BNFC contains essential practical information for all healthcare professionals involved in prescribing, dispensing, monitoring and administration of medicines to children.

  • Good Pharmacovigilance Practice Guide

    An essential guide on pharmacovigilance of medicinal products for human use. Practical advice for developing effective pharmacovigilance systems.

  • Martindale: The Complete Drug Reference

    Martindale: The Complete Drug Reference provides reliable, unbiased and evaluated information on drugs and medicines used throughout the world.

  • British National Formulary (BNF) 77

    BNF 77 (March 2019) is your essential reference book for prescribing, dispensing, and administering medicines.


Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete

Jobs you might like

  • London

  • London (Central), London (Greater)

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.