Brexit-related guidance for companies

  • Email
  • Help

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 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
  • authorisation of different types of products, such as generic, hybrid and biosimilar medicines
January 2018
  • necessary changes to marketing authorisations
January 2018
  • legal obligations
January 2018

 

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 in October 2017:

Update: On 23 January 2018, EMA launched a survey to gather information from marketing authorisation holders of centrally authorised medicines who are located in the UK or who have quality control, batch release and/or import manufacturing sites or a QPPV or pharmacovigilance system master file (PSMF) in the UK, on their plans to submit transfers, notifications or variations to their marketing authorisations in preparation for Brexit.

The aim is to:

  • identify companies where there is a need for concerted action to address medicines supply concerns due to Brexit in order to protect human and animal health;
  • help EMA and the Commission plan resources in the areas where these submissions will be processed.

The survey also serves to stimulate those companies who have not yet taken any action to start planning for any regulatory steps required for their centrally authorised products to remain on the EU market post-Brexit in order to minimise disruption to medicines supply and avoid shortages.

EMA has sent the survey directly to these marketing authorsiation holders, who should complete it by 9 February 2018. The Agency will publish a high-level summary of the overall results.

EU national competent authorities may carry out further surveys in relation to nationally authorised products.

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

How helpful is this page?

Average rating:

 Based on 38 ratings

Add your rating:

See all ratings
9 ratings
6 ratings
7 ratings
8 ratings
8 ratings
    

Tell us more

Related content

News and press releases

External links