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.
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.
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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:
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.
In September 2018, EMA revised the number down to 39 centrally authorised products for which it remained concerned about potential Brexit-related supply disruptions.
EMA continues working directly with the marketing authorisation holders to address any outstanding issues. It will also discuss relevant mitigation measures with its scientific committees, including recommendations on possible therapeutic alternatives to which patients could be switched if necessary.
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.
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.
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 stakeholder meeting on Brexit and operation of centralised procedure for human and veterinary medicines (24/09/2018)
- Brexit regulatory preparedness for veterinary medicinal products in the centralised procedure (20/04/2018)
- Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicines (23/03/2018)
- Industry stakeholder teleconference on Brexit and operation of the centralised procedure for veterinary medicines (13/10/2017)
- Industry stakeholder meeting on Brexit and operation of the centralised procedure for human medicines (04/10/2017)