Brexit-related guidance for companies

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.

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.

Document Contains information on Last updated
February 2019
  • necessary changes to marketing authorisations
  • impact on ongoing procedures
  • Impact on generic, hybrid and biosimilar applications
  • necessary changes to orphan designations
  • submission of safety information originating in the UK
February 2019
  • legal obligations
February 2019

Change of format for pre-submission meetings

For human and veterinary initial marketing authorisation applications, EMA will hold all pre-submission meetings requested as of 1 October 2018 remotely, either via teleconference or virtual meeting, until the Agency is fully operational in its new permanent premises at the end of 2019.

Between 11 February and 15 March 2019, no pre-submission meetings for initial marketing authorisation applications will take place, while EMA moves to its new premises.

For more information, see:

EMA holds pre-submission meetings for scientific advice exclusively by teleconference as of September 2018.

Delays in processing EMA certificates

EMA will not print or dispatch certificates for pharmaceutical products from 25 February until 14 March 2019.

Companies can still submit requests during this period, which EMA will continue to process. EMA will resume printing and dispatching certificates on 14 March 2019.

For more information, see:

Industry survey (for centrally authorised products)

EMA carried out a Brexit-preparedness survey in 2018, to gather information from marketing authorisation holders on their preparedness for Brexit.

The main aim was to to obtain information on the timelines for submission of necessary regulatory changes, and identify any centrally authorised products at potential risk of supply shortages. EMA published a high-level summary of the results in July 2018:

Based on the survey results, EMA was concerned about potential supply shortages for 108 medicines (88 human and 20 veterinary). EMA contacted the marketing authorisation holders between July and September 2018 and received reassurance on the regulatory planning for a significant proportion. 

Update: In October 2018, EMA revised the number down to 31 centrally authorised products (19 human medicines and 12 veterinary medicines) for which it remained concerned about potential Brexit-related supply disruptions. 

EMA, together with its scientific committees, has assessed how critical these products are for the treatment of the disease they target. National competent authorities will check whether there are possible therapeutic alternatives available in their country. 

The number of medicines considered to be at risk are subject to change based on updates provided by the marketing authorisation holders. EMA continues working with them directly to address any outstanding issues.

The survey involved marketing authorisation holders for 694 centrally authorised products (661 human and 33 veterinary products) either located in the UK or with quality control, batch release and/or import or manufacturing sites, or a QPPV or pharmacovigilance system master file (PSMF) in the UK.

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

Guidance on nationally authorised products

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