Brexit-related guidance for companies

The European Medicines Agency (EMA) and the European Commission have been providing guidance to help pharmaceutical companies prepare for the consequences of Brexit since 2017. This includes companies responsible for human medicines and for veterinary medicines, both centrally and nationally authorised.

The Protocol on Ireland / Northern Ireland forms part of the withdrawal agreement that established the terms of the UK's withdrawal from the EU. Based on this Protocol, EU pharmaceutical law applies to and in the UK in respect of Northern Ireland only, as of 1 January 2021.

Guidance for companies on the impact of this Protocol and their activities within Northern Ireland is available in the document below:

The Protocol is subject to periodic consent of the Northern Ireland Legislative Assembly. Its initial period of application is four years from 1 January 2021.

Pharmaceutical companies had until 31 December 2020 to make the necessary changes to ensure that their centrally and nationally authorised medicines complied with EU law in order to remain on the EU market.

During the transition period, EU pharmaceutical law as laid out in the ‘acquis communautaire' continued to apply to the UK.

For more information, see: 

• Industry stakeholder webinar on the UK withdrawal from the European Union - End of transition period(30/11/2020)

Under 'Annex TBT 2 - Medicinal Products' of the EU-UK Trade and Cooperation Agreement, the EU and the UK shall recognise the outcomes of good manufacturing practice (GMP) inspections carried out by the other party in their territories.

This applies to the manufacture of medicines for human and veterinary use, including:

• biological and immunological products;
• advanced therapy medicinal products;
• active substances for human and veterinary medicinal products;
• investigational medicinal products. 

The agreement also foresees the possibility of EU recognition of inspections carried out by the UK authorities in third countries. Applicants and marketing authorisation holders may submit UK-issued GMP certificates for sites located in third countries as supporting information for regulatory submissions in the EU, for consideration as part of the evaluation as appropriate.

For more information, see: 

• European Commission: The EU-UK Trade and Cooperation Agreement
• European Commission, DG Trade: EU-UK Trade and Cooperation Agreement
• International collaboration on GMP inspections

Document	Contains information on	Last updated
Questions and answers to stakeholders on the implementation of the Protocol on Ireland / Northern Ireland	EU-UK Trade and Cooperation Agreement Changes required in the Article 57 database Fees Safety reporting into EudraVigilance and access to EudraVigilance data European Union Drug Regulating Authorities Clinical Trials Database (EudraCT) Electronic Application Forms Periodic safety update report (PSUR) repository Organisation Management Services Product information Marketing status reporting Dossier submission SME incentives Orphan designation sponsors Good manufacturing practice and manufacturing Parallel distribution	March 2021
European Commission / EMA notice to stakeholders (including questions and answers)	Legal considerations after the end of the transition period, including on: issues related to marketing authorisations and related procedures manufacturing and importation of finished products and active pharmaceutical ingredients parallel trade pharmacovigilance orphan medicines, traditional herbal medicinal products product information and labelling safety features inspection results Provisions for products placed on the market before the end of the transition period Applicable rules in Northern Ireland after the end of the transition period	March 2020
EMA practical guidance	Procedural and practical guidance regarding submission of changes and related fees, including: necessary changes to marketing authorisations impact on ongoing procedures impact on compliance assessments impact on generic, hybrid and biosimilar applications necessary changes to orphan designations submission of safety information originating from the UK UK nationally authorised products in European procedures	March 2020
European Commission notice to stakeholders on application of the EU pharmaceutical acquis in markets historically dependent on medicines supply from Great Britain	Guidance on possible exemptions for selected markets with regards to: imports from Great Britain; batch release testing in Great Britain; complying with provisions for the placement and verification of the unique identifier. For queries and requests for exemptions for batch release testing in Great Britain (for centrally authorised products), write to: emabrexitsurveyfu@ema.europa.eu (for human medicines) vet.applications@ema.europa.eu (for veterinary medicines)	January 2021

Further information in the form of notices to stakeholders published by the European Commission are available on the European Commission's website.

The Coordination Groups for Mutual Recognition and Decentralised Procedures - Human (CMDh) and Veterinary (CMDv) - provided information for marketing authorisation holders of nationally authorised products:

• CMDh: Brexit-related information for nationally authorised human medicines
• CMDv: Brexit-related information for nationally authorised veterinary medicines

Reports from EMA's meetings with industry stakeholders on preparations for Brexit are available below. These include updates from EMA and from EU industry associations on their activities.

• Industry stakeholder meeting on Brexit and operation of centralised procedure for human and veterinary medicines(24/09/2018)
  • Report
• Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure (20/04/2018)
  • Report
• Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicines (23/03/2018)
  • Report
• Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicines (13/10/2017)
  • Report
• Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicines (04/10/2017)
  • Report