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:
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:
|Document||Contains information on||Last updated|
|Questions and answers to stakeholders on the implementation of the Protocol on Ireland / Northern Ireland||March 2021|
Procedural and practical guidance regarding submission of changes and related fees, including:
|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:
For queries and requests for exemptions for batch release testing in Great Britain (for centrally authorised products), write to:
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:
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)
- Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure (20/04/2018)
- Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicines (23/03/2018)
- Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicines (13/10/2017)
- Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicines (04/10/2017)