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.

 

During the transition period, medicines and devices regulation will stay aligned with the EU from 1 February 2020 until 31 December 2020.

New MHRA guidance issued on 31 January 2020 confirmed that during this transition period:

  • Market access will not change
  • Pharmaceutical firms can continue UK batch release testing and Qualified Person certification in the UK, with this being recognised by the EU and vice versa
  • Marketing authorisation holders and qualified persons for pharmacovigilance (QPPV) can continue to be based in the UK and access EU markets
  • A UK QPPV and Pharmacovigilance System Master File (PSMF) will not be required, as the UK will continue to operate under EU legislation using the EU QPPV and PSMF
  • There will be continued mutual recognition of manufacturing and distribution licences, as well as associated inspections such as good manufacturing practice (GMP)
  • Firms based in the UK will be able to continue to apply for marketing authorisations via either the centralised or decentralised procedures
  • The UK can continue to participate in the decentralised and mutual recognition licensing procedures but is excluded from acting as Reference Member State (RMS) in these procedures for approval of marketing authorisations. In addition, the UK cannot act as a rapporteur or co-rapporteur the UK cannot act as a rapporteur or co-rapporteur in the Community Marketing Authorisation procedure
  • Community Marketing Authorisations (CMAs) will continue to be valid in the UK and submission routes used in the transition period should be unchanged from those used prior to 31 January 2020. No action is needed in relation to those products for which Product Licence (PL) numbers have already been issued and there is no requirement for a baseline submission to be submitted at this time.  If a CMA has been allocated a PL number, do not use the number for any other future marketing authorisation you intend to submit to the UK
  • Firms can continue to submit information to the MHRA, using the existing submission routes
  • The UK can continue to report to systems that we have access to

MHRA guidance on the transition period also states that:

  • The UK will not act as ‘leading authority’ for medicines.  A ‘leading authority’ conducts assessments on behalf of specific EU agencies. The UK and EU are still discussing the scope of activity that this will cover with respect to medicines.
  • UK authorities will remain available to provide expert advice during this period, and UK businesses will have the same rights during the transition period as EU-based businesses to have their cases accepted and processed by EU agencies and EU-based leading authorities.
  • Some elements of the MHRA’s role will change. For example, the UK will no longer have voting rights in the European Medicines Agency (EMA) and EU committees but will continue to respect their decisions regarding regulation of medicines and medical devices.

 

Intellectual Property

Guidance from the IPO on IP and Brexit during the transition period

Exhaustion of IP rights and parallel trade from 1 January 2021

Changes to SPC and patent law if the UK from 1 January 2021

Personal data

Using personal data in your business or other organisation during and after the transition period

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)

 

Previous ‘no deal’ guidance

If new arrangements on medicines and devices 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 equivalent to the ‘no deal’ scenario for which the government provided guidance ahead of 31 October 2019 - see the links below.

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

 

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

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

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