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.

The Medicines and Healthcare Products Regulatory Agency has published post-transition period guidance for industry on medicinal products and active substances regulation following the end of the transition period on 1 January 2021. It includes information on licensing, clinical trials and import/export. It does not cover products entering Northern Ireland from Great Britain. MHRA is holding a series of webinars on the guidance from 19 October to 29 October.

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 in the UK from 1 January 2021

Personal data

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

Pharmacovigilance

Guidance on qualified person for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

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