Recent Brexit news of note to regulatory affairs

The following news updates originated in our Life-Lines newsletter, a fortnightly members-only email produced in partnership with international law firm Pinsent Masons. For more extensive insight into Brexit's possible effects on healthcare regulatory affairs, plus other recent life sciences-related legal and regulatory developments, become a TOPRA member to receive Life-Lines directly.

September 2020

• MHRA: List of approved countries for authorised human medicines from 1 January 2021
• MHRA: Post-transition period information for the following topics:
  • Clinical trials
  • Devices
  • Licensing
  • Importing and exporting
  • IT systems
  • Pharmacovigilance
  • Paediatrics
• National Institute for Biological Standards and Control (NIBSC): information for manufacturers of biological medicines

July 2020

• Technical notice to sponsors of clinical trials post-Brexit focuses on 'establishment'
• European Commission on readiness for the end of the transition period
• MOJ consults on departure from retained EU case law by UK courts and tribunals

June 2020

• UK's post-Brexit product liability and safety laws 'could cause confusion'
• European Commission publishes readiness notices to stakeholders, including notices for:
  • Supplementary protection certificates (SPCs) for medicinal and plant products
  • Good laboratory practice (GLP)
  • All EU readiness notices
  • Clinical trials (including the supply of investigation products and establishment requirements)
  • Biocidal products
  • Exhaustion of rights
  • Medicinal products (including GMA, batch release, parallel imports, orphans and multipacks)

May 2020

• Notice on Brexit and clinical trials for stakeholders

April 2020

• UK confirms non-participation in Unified Patent Court

March 2020

• Call for post-Brexit medicines regulation guidance
• Supply and safety of medicines post Brexit
• Pharmaceutical regulation and legislation during the transition period
• MHRA: Quality and safety of human blood and blood products
• Transition period deadline remains despite COVID-19 pandemic

February 2020

• Q&A document on what European authorities are doing to avoid shortages of medicines due to Brexit
• EMA: Pharmaceutical regulation and legislation during the transition period
• Pinsent Masons: Medical device regulation and legislation during the transition period
• Brexit: Quality and safety of human blood and blood products (MHRA)
• UK data protection divergence post Brexit
• Gov.uk - Brexit: IPO guidance on IP rights
  
   

January 2020

• The UK VMD has updated its Brexit Information Hub to provide details of the implementation period
• EMA clarification on the UK's withdrawal from the EU on 31 January 2020
• FVE statement: The European veterinary profession remains united
• AnimalhealthEurope statement: AnimalhealthEurope continues close work with NOAH

November 2019

• International trade mark registrations after Brexit

October 2019

• No deal guidance on comparator products
• Updated no deal guidance for manufacturers of biological medicines - independent batch release in the UK
• Government secures contracts to ensure continued flow of vital medicines after Brexit
• Updated guidance for sponsors of clinical trials
• Updated guidance on pharmacovigilance system master files
• GxP risk-based inspection programmes in a no deal Brexit scenario
• Guideline on paediatric investigation plans, waivers, deferrals and compliance check

September 2019

• Irish medical device manufacturers facing Brexit challenges
• UK Government Border Delivery Group advice for EU businesses trading with or via the UK
• MHRA sets out exceptions to good pharmacovigilance practices guidance post-Brexit
• Brexit and the threat of supply chain failure
• Guidance on regulating medical devices in a no-deal Brexit
• Changes to SPC and patent law in the event of Brexit without a withdrawal agreement
• Update on the DHSC's plans to support the continuity of supply of medical products
• Brexit impact on UPC project acknowledged by Germany
• EU-UK trade in a no-deal scenario

July 2019

• UK consults on 'no deal' Brexit SPC waiver law
• OBR analysis highlights no-deal Brexit economic risk
• Guidance on exporting active substance manufactured in the UK in a no deal scenario
• UK court will not hear Brexit 'frustration' appeal until after exit date
• FT report: EMA has withdrawn its 'frustration' appeal 
• Medicines and medical products: continuity of supply update
• (UK) EU Exit preparedness: Written statement 

• House of Commons product standards and safety marking briefing paper
• EMA Brexit preparedness from June 2019 management board meeting
• European Commission preparedness for no-deal Brexit

May 2019

• Briefing paper on Brexit and medicines regulation (HoC Library)
• UK government outlines commitment to being a life sciences powerhouse in a post-Brexit world (MHRA)
• Exporting active substances manufactured in the UK if a no-deal Brexit occurs
• EMA updates Brexit Q&A on avoiding shortages of medicines
• Guidance on exporting active substance manufactured in the UK in a no-deal scenario (MHRA)
• Ireland's HPRA's guidance on the importation of finished medicinal products post-Brexit
• Clinical Trials - impact of Brexit

April 2019

• Export of medicines: certificate of a pharmaceutical product in no-deal scenario (MHRA)
• Conditional marketing authorisations , exceptional circumstances marketing authorisations and national scientific advice in a no-deal scenario (MHRA)
• New guidance page on substantial amendments to a clinical trial if the UK leaves the EU with no deal (MHRA)
• DHSC - Guidance on prescriptions issued in the EEA and Switzerland

March 2019

• BEIS updates for the life sciences sector
• EMA advises submitting type I variations ASAP
• SPC and patent law guidance in a no-deal Brexit
• Security for costs post-Brexit
• Guidance on MHRA submissions in a no-deal scenario
• Businesses not ready for 'no deal' Brexit
• HMRC urges businesses to take three steps to prepare for no-deal Brexit
• No-deal handbook: A practical guide to preparing for a possible no-deal Brexit
• MHRA guidance and publications on a possible no-deal scenario
• EU actions to prevent medicine shortages due to Brexit
• The Conformity Assessment (Mutual Recognition Agreements) Regulations 2019

February 2019

• HPRA: Confirmation dual UK and Irish labels for medicines are acceptable
•  European Commission: Updated medicinal products FAQ
• Data Protection Commission - Ireland: Irish watchdog issues no-deal Brexit data transfers guidance
• Department of Health and Social Care - UK: Updated guidance for suppliers of medicines or medical devices in no-deal scenario
•  Out-Law.com: EURid: Brexit cancellation of .eu domain names confirmed
•  Out-Law.com: HMRC publishes no-deal Brexit simplified customs procedure
•  Gov.UK: Regulatory compliance in a no-deal Brexit
•  BSI: MedTech market access – some clarification from the BSI and Competent Authorities

January 2019

• MHRA: Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
• MHRA: UK to recognise medical device 'CE' marks after 'no deal' Brexit
• House of Commons briefing on repercussions of a ‘no deal’ Brexit
• UK government guidance on how to prepare if the UK leaves the EU with no deal
• Brexit response: Irish drugs regulator loosens packaging rules
• UK goods face EU transport restrictions if post-Brexit competition is not 'fair'

December 2018

• CJEU: UK can revoke Brexit unilaterally
• UK supplies face six month disruption under 'no deal' Brexit
• Brexit briefing: the Withdrawal Agreement
• 'No deal' Brexit EU citizens' rights plans published

November 2018

• Businesses urged to accelerate IP registrations
• UK Government publishes statutory instrument to address exhaustion of IP rights
• Timescale set for data protection 'adequacy' decision
• UK publishes rules for cross-border mediation post-Brexit

Pinset-Masons have produced a briefing on the Brexit Withdrawal Agreement summarising the accord's key points with a focus on:

• The Brexit withdrawal process under the Withdrawal Agreement
• The arrangements during the proposed transition period and so-called 'backstop' arrangement
• The key areas covered by the Withdrawal Agreement, including Citizens' Rights, Data, and VAT & Excise
• Actions that businesses should be taking now in order to prepare for Brexit

October 2018

• Life sciences companies urged to prepare for various Brexit scenarios
• EU Exit no-deal contingency legislation for the regulation of medicines and medical devices
• Parliamentary Committee on the impact of a no-deal Brexit – call for evidence
• How to manage Brexit supply chain risks
• UK government urged to fund Brexit stockpiling of medicines

August 2018

• UK Government publishes “no-deal” Brexit advice, including 25 "technical notices" setting out what it is doing to prepare for no-deal, of which one relates to regulating medicines and medical equipment. The guidance relating to this are:
  • Batch testing medicines if there's no Brexit deal
  • Ensuring blood and blood products are safe if there’s no Brexit deal
  • How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal
  • Submitting regulatory information on medical products if there’s no Brexit deal
  • Quality and safety of organs, tissues and cells if there’s no Brexit deal

July 2018

• NHS working to secure medicine supply and equipment under different Brexit scenarios 
• Ireland's Health Products Regulatory Authority (HPRA) has highlighted its willingness to take over the role of reference member state for UK pharmaceutical companies, following the new 'question and answer' paper issued by the EMA and Commission.
• Ireland joins Beneluxa initiative on access to drugs and pricing
• The European Union (Withdrawal) Act 2018, outlining UK rules and laws in relation to Brexit, received Royal Assent on 26 June 2018, paving the way for the UK's withdrawal from the EU.
• UK Brexit plan published, but 'major hurdles' remain
• EMIG survey finds growing Brexit concerns among life sciences companies
• Results from EMA survey in preparation for Brexit

June 2018

• Guidance for pharmaceutical companies from the European Medicines Agency and the Commission on preparing for the UK's withdrawal from the EU has been updated
• Ireland may provide Brexit solution to UK pharmaceuticals
• Ireland's pharma-chemical sector needs protection from Brexit
• Customs enforcement of intellectual property rights post-Brexit
• New EU R&D programme could be open to post-Brexit UK
• Brexit: Irish border 'backstop' to run until 2021, says UK

May 2018

• Brexit – guidance to stakeholders on impact in the field of SPCs
• New report – Dispute resolution and enforcement post Brexit
• EU: Brexit 'no deal' will hit copyright and database owners
• Government confirms UK may consider changes to parallel trade rules post Brexit
• Regulatory divergence biggest Brexit concern for pharma  

April 2018

• Briefing paper: new guidelines on the framework for future EU-UK relations 
• No change to substantive competition and state aid rules after Brexit  
• Half of major UK businesses have triggered Brexit plans, says research
• Why companies need to consider Brexit scenario planning , and what it involves
• Agreement reached on 'large part' of Brexit transition arrangements
• Future UK-EU relationship – new UK Committee report 
• Brexit: EU27 agree guidelines on future UK trade
• Brexit 'no deal' will hit copyright and database owners

March 2018

• UK eligibility to participate in existing and future EU Research programmes
• UK and EU regulation to be 'substantially similar' post-Brexit
• Mapping progress of the EMA's move to Amsterdam.
• EMA stakeholder meeting on Brexit and operation of the centralised procedure
• Draft EU withdrawal bill sets out Irish border 'fall-back'

February 2018

• EU Draft Withdrawal Agreement published
• UK publishes preferred approach to post-Brexit transition
• Wellcome: European Research Area should be strengthened to boost science post-Brexit

General information about the referendum

See the website of the UK Parliament for information on the referendum and the process for UK withdrawal from the EU.

Brexit: What happens now? BBC, 29 June 2016. In particular, scroll down for the useful graphic, 'Steps to the EU leaving the European Union'