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.
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Guidance on the Protocol on Ireland / Northern Ireland / Windsor Framework

The Protocol on Ireland / Northern Ireland, also referred to as the Windsor Framework, forms part of the withdrawal agreement that established the terms of the UK's withdrawal from the EU.

Based on the Protocol, EU pharmaceutical law applies to and in the UK in respect of Northern Ireland only, as of 1 January 2021, to the extent described in the Protocol.

Guidance for companies on the impact of this Protocol and their activities within Northern Ireland is available in the "Guidance documents" section on this page.

    Guidance documents

    Questions and answers to stakeholders on the implications of Regulation (EU) 2023/1182 for centrally authorised medicinal products for human use

    Reference Number: EMA/581345/2023 Rev. 2

    English (EN) (241.8 KB - PDF)

    First published: Last updated:
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    This document contains information on:

    • Scope and applicability of Regulation (EU) 2023/1182
    • Authorisation and supervision of medicinal products eligible to the centralised procedure to be placed on the market in Northern Ireland
    • Transitional provisions 
    • Multi-country packs for centrally authorised products between Northern Ireland / UK and an EU / EEA Member State
    • Update of the product information for centrally authorised products
    • Marketing status reporting
    • Parallel distribution
    • Changes required in the Article 57 database
    • Safety reporting into EudraVigilance and access to EudraVigilance data
    • Issues related to marketing authorisations and their procedures

    Questions and answers to stakeholders on the implementation of the protocol on Ireland / Northern Ireland

    Reference Number: EMA/520875/2020 Rev. 3

    English (EN) (315.19 KB - PDF)

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    This document contains information on: 

    • 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

    Notice to stakeholders - Withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products

    English (EN) (620.01 KB - PDF)

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    This document contains information on: 

    • 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

    Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure

    Reference Number: EMA/478309/2017 Rev. 5

    English (EN) (351.65 KB - PDF)

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    This document features:

    • 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

    European Commission notice to stakeholders on application of the EU pharmaceutical acquis in markets historically dependent on medicines supply from Great Britain

    This document contains:

    • information on 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:

    Impact of EU-UK Trade and Cooperation Agreement

    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: 

    Stakeholder meeting reports

    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.

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    Report of Industry Stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products

    Reference Number: EMA/694143/2018

    English (EN) (144.46 KB - PDF)

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    Report - Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure

    Reference Number: EMA/271499/2018

    English (EN) (163.27 KB - PDF)

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    Minutes - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products

    English (EN) (260.25 KB - PDF)

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    Report - Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicinal products

    Reference Number: EMA/686513/2017

    English (EN) (160.24 KB - PDF)

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    Report - Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicinal products

    Reference Number: EMA/664332/2017

    English (EN) (124.44 KB - PDF)

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