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 in the EU for the benefit of patients, based on the assumption that the UK will become a third country as of 30 March 2019. 

On this page

Guidance on centrally authorised products  

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 entities, including:
    • marketing authorisation holders and applicants;
    • orphan designation holders;
    • qualified persons for pharmacovigilance (QPPVs);
    • minor use/minor species (MUMS)/limited markets classification holders;
    • companies' manufacturing and batch release sites.
  • effects of Brexit on marketing authorisation applications, batch release processes and inspection outcomes by the UK national competent authority
  • authorisation of different types of products, such as generic, hybrid and biosimilar medicines and ancillary medicinal substances in medical devices
  • multi-country packs of medicines, where one of the countries in which the packs are to be sold is the UK
June 2018
  • necessary changes to marketing authorisations
June 2018
  • legal obligations
January 2018

Guidance on nationally authorised products 

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

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

Stakeholder meetings 

EMA has published reports with updates from the Agency and EU industry associations on their preparations for Brexit and information on planned stakeholder engagement activities from the Agency's meetings with industry stakeholders:

Industry survey (updated)

EMA carried out a Brexit-preparedness survey in 2018 to gather information from marketing authorisation holders for centrally authorised products on their plans to update their marketing authorisations in preparation for Brexit.

The main objective was to to gather information on the timelines for submission of the necessary regulatory changes and identify any centrally authorised products potentially at risk of supply shortages

EMA sent the survey to marketing authorisation holders of 694 centrally authorised products (661 human and 33 veterinary products) either located in the UK or with an important step in their regulatory processes in the UK, such as quality control, batch release and/or import manufacturing sites, QPPV and pharmacovigilance system master file (PSMF).  

According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the EEA for a company to be able to market a medicine in the EU.

EMA published a highl-level summary of the results in July 2018:

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