Brexit-related guidance for companies
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. This is due to end on 31 December 2020.
Since 2017, the European Medicines Agency (EMA) and the European Commission have been providing guidance to help pharmaceutical companies responsible for both human and veterinary medicines prepare for the consequences of Brexit.
The withdrawal agreement establishes the terms of the UK's withdrawal from the EU on 31 January 2020, including a transition period that began on 1 February 2020 and is due to end on 31 December 2020.
During the transition period, EU pharmaceutical law as laid out in the ‘acquis communautaire' will be applicable to the UK.
This means that pharmaceutical companies have until 31 December 2020 to make the necessary changes to ensure that their centrally and nationally authorised medicines comply with EU law and can remain on the EU market.
For example, the following entities can still be located in the UK until 31 December 2020:
Companies should check this page regularly for guidance on the consequences of Brexit, as EMA and the European Commission are maintaining a series of guidance documents.
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Procedural and practical guidance regarding submission of changes and related fees, including:
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 encourages marketing authorisation holders to submit Brexit-related type IA and type IB variations as early as possible, to enable EMA to confirm compliance with regulatory and legal requirements by the end of the Brexit transition period.
According to EU law, the marketing authorisation holder, QPPV, pharmacovigilance system master file (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.
Marketing authorisation holders should email email@example.com (copying the Product Lead and the product mailbox) if their plans change for submitting Brexit-related post-authorisation applications.
EMA continues to urge pharmaceutical companies to make the changes required by EU law to continue to market a medicine in the EU after the Brexit transition period.
In March 2020, just one marketing authorisation (for a human medicine) still needed to be transferred from the UK to an EU27 Member State. Good progress had been made for products with QPPVs and pharmacovigilance system master files (PSMFs) based in the UK. Although companies have reassured EMA that their plans are in place, the Agency reminds them of their responsibility to make the necessary changes required by EU law as soon as possible.
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 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, 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 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 PSMF in the UK.
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)