Regulation & IP
Following the publication of the UK-EU Trade and Cooperation Agreement, the MHRA has updated all of its guidance for the end of transition.
The European Commission has published further guidance on the application of the Union's pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain (N Ireland, Malta). This is the 'timed phased approach' or derogation.
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.
On 8 February, the MHRA published updated Brexit FAQs.
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
Using personal data in your business or other organisation during and after the transition period
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