Regulation & IP

The UK’s withdrawal from the EU will have an impact on the regulation of medicines, medical devices and clinical trials, and the protection of IP.

 

The BIA position is that close cooperation with the EU in the regulation of medicines, including mutual recognition of regulatory activities and quality testing, is essential in ensuring that patients in the UK and the EU can continue to access safe and effective medicines.

If, as expected, the UK leaves the EU on 31 January and enters the Transition Period, medicines and devices regulation will stay aligned with the EU from 1 February 2020 until 31 December 2020.

 

During this transition period:

 

  • Firms can continue UK batch release testing and QP certification
  • MA holders, QPs and QPPVs can continue to be based in the UK
  • Manufacturing and distribution licences and inspections will continue to be recognised
  • CE marking will continue to be used and recognised
  • UK notified bodies can continue to conduct third-party conformity assessment
  • UK will be treated as a Member State for the purposes of MRAs
  • Licence for a Centrally Authorised Product will be valid in the EU and UK

If new arrangements on medicines and device regulations are not agreed with the EU by 31 December 2020, trade between the UK and EU would revert to WTO rules.  This could be the equivalent to the 'no deal' scenario for the government provided guidance ahead of 31 October 2019 and which is set out in the links below.  

 

Guidance from the MHRA

Guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal

Collection of guidance and publications about a possible no-deal Brexit

Guidance on how to register to make submissions to the MHRA in the event of no deal

 

Webinars on how to submit regulatory information in the event of no-deal

 

Regulation of medicines and clinical trials

Guidance on marketing authorisations, variations and licensing guidance if there is a no-deal Brexit

Guidance on importing and exporting medicines if there is a no deal Brexit

Guidance on the regulation of medicines for children if there’s a no-deal Brexit

Guidance on regulatory submissions and vigilance activities if there is a no-deal Brexit

DHSC guidance to sponsors of clinical trials

 

Regulation of medical devices

What you need to know about the regulation of medical devices in the UK if we leave the EU with no deal

 Human tissue and organs

Guidance from the HTA on the handling and transport of human tissue and organs if there is a no-deal Brexit

Data

Guidance and resources to help SMEs prepare for data protection compliance after a no-deal Brexit

Intellectual Property

Guidance from the IPO on IP and Brexit

Changes to SPC and patent law if the UK leaves the EU without a deal

The Government has consulted on how the SPC manufacturing waiver will operate in a no-deal scenario but no decision has yet been made

Information from the European Medicines Agency

Guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for Brexit

Information on EMA preparedness and business continuity planning

Information from the EU Heads of Medicines Agencies (HMA)

Brexit updates from the Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh)