Brexit-related guidance for companies

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The European Medicines Agency (EMA) and the European Commission are providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the United Kingdom's (UK) withdrawal from the European Union (EU), a process known as 'Brexit'.

This aims to ensure that companies are ready to take the necessary steps to enable undisrupted supply of their medicines for the benefit of patients, based on the assumption that the UK will become a third country as of 30 March 2019. 

Guidance on centrally authorised medicines

Companies should check this page regularly for guidance on the consequences of Brexit, as EMA and the European Commission are preparing a series of guidance documents. 

DocumentContains information onLast updated
  • location of:
    • establishment of a company;
    • orphan designation holders;
    • qualified persons for pharmacovigilance (QPPVs);
    • companies' manufacturing and batch release sites.
  • effects of brexit on marketing authorisation applications
  • authorisation of different types of products, such as generic, hybrid and biosimilar medicines
November 2017
  • necessary changes to marketing authorisations
November 2017
  • legal obligations
May 2017


In addition, a report is available with updates from EMA and EU trade industry associations on their preparations for Brexit and information on planned stakeholder engagement activities from the Agency's meeting with industry stakeholders:

Guidance on nationally authorised products

The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) has also published information for marketing authorisation holders of nationally authorised products for human use. 

For more information, see the Heads of Medicines Agencies (HMA) website

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