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.
Update: European Council adopts decision extending the period under 'Article 50'
Following the European Council meeting on 22 March 2019, the date for UK's withdrawal from the EU has been extended beyond 30 March 2019.
Under the European Council decision, if the withdrawal agreement between the UK and the EU is approved by the UK House of Commons by 29 March 2019, the extension will be until 22 May 2019. If the withdrawal agreement is not approved by 29 March 2019, the extension will be until 12 April 2019. In that event, the UK will indicate a way forward before 12 April 2019, for consideration by the European Council.
The decision makes clear that the UK remains a Member State for the duration of the extension, with all the rights and obligations set out in the treaties and under EU law.
EMA calls on all pharmaceutical companies in the EU to continue their preparedness for the UK’s withdrawal.
Based on the European Council decision, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood to be replaced by 12 April 2019 until further notice.
For more information, see:
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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Exemption for batch testing of medicines in UK after 29 March 2019
Marketing authorisation holders who are unable to transfer their batch testing site from the UK to the EU27 by 29 March may be permitted, for a limited period of time, to rely on quality control testing performed in the UK under certain conditions. For more information, see:
- European Commission communication on EU rules for batch testing of medicines in relation to the UK's withdrawal from the EU
For requesting an exemption for a centrally authorised medicine, marketing authorisation holders should use the following template:
They should submit a scanned and signed copy as well as an editable version of the request to EMA via email or Eudralink to firstname.lastname@example.org (copying the Product Lead and the product mailbox for human medicines and email@example.com for veterinary medicines) as soon as possible and no later than by 29 March 2019.
EMA will notify individual marketing authorisation holders whether their request has been granted as quickly as possible. Marketing authorisation holders whose request for exemption has been granted must notify the relevant national competent authority(ies). For more information, see page 22 of EMA's practical guidance
Submission of Brexit-related type I variations
EMA is encouraging marketing authorisation holders to submit Brexit-related type IA and type IB variations as early as possible in March 2019, to enable EMA to confirm compliance with regulatory and legal requirements by 29 March 2019.
For more information and guidance, see:
Marketing authorisation holders should email firstname.lastname@example.org (copying the Product Lead and the product mailbox) if their plans change for submitting Brexit-related post-authorisation applications.
EMA expects an increase of over 50% in the volume of type I variation submissions from March-May 2019. To allow EMA to process these as quickly as possible, marketing authorisation holders are asked not to include editorial changes as part of variation applications in this period. For more information on what is an editorial change, see 'Editorial changes' onClassification of changes: questions and answers.
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 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.
The Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) and Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) have published information for marketing authorisation holders of nationally authorised products.
For more information, see:
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">centralised procedure for human and veterinary medicines as Link} (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)