Brexit-related guidance for companies
Table of contents
- Extension of the period under 'Article 50'
- Guidance on centrally authorised products
- Brexit-preparedness of centrally authorised products
- Exemption for batch testing of medicines in UK
- Submission of Brexit-related type I variations
- Change of format for pre-submission meetings
- Guidance on nationally authorised products
- Stakeholder meetings
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.
On 29 October 2019, the European Council agreed to a further extension of the date for the UK’s withdrawal from the EU. The extension will last as long as necessary and, in any event, no longer than 31 January 2020. For more information, see:
- European Council decision taken in agreement with the United Kingdom, extending the period under Article 50(3) TEU (28/10/2019)
- European Commission: Brexit preparedness activities
The UK remains an EU Member State for the duration of the extension.
EMA calls on all pharmaceutical companies in the EU to continue their preparedness for the UK’s withdrawal.
Based on the European Council decision, and until further notice, the deadline of 29 March 2019 referred to in Brexit related guidance should be understood as referring to 31 January 2020.
Companies should check this page regularly for guidance on the consequences of Brexit, as EMA and the European Commission are delivering and maintaining a series of guidance documents.
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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.
EMA continues to urge pharmaceutical companies to make the changes required by EU law to enable them to continue to market a medicine in the EU after Brexit.
In June 2019, just three marketing authorisations (for human medicines) still needed to be transferred from the UK to an EU27 Member State. Good progress had also 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 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, 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.
Marketing authorisation holders who are unable to transfer their batch testing site from the UK to the EU27/EEA by the date of Brexit may be permitted, for a limited period of time, to continue relying on quality control testing performed in the UK after Brexit.
A key condition for this exemption is that all necessary steps have been taken to prepare the transfer of the quality control testing site to the EU27/EEA.
Marketing authorisation holders requesting the exemption must confirm and set out their precise timetable for transfering the quality control testing site. The transfer shoud be completed quickly and in principle by the end of 2019 at the latest.
It is essential that marketing authorisation holders use the time remaining to complete their preparations, so that by 1 January 2020 all batch testing facilities are fully transferred to the EU27/EEA and the necessary regulatory submissions are completed.
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 the date of Brexit.
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
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 date of Brexit.
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.
For human and veterinary initial marketing authorisation applications, EMA holds all pre-submission meetings requested as of 1 October 2018 remotely, either via teleconference or virtual meeting. This is expected to last until the Agency is fully operational in its new permanent premises. For more information, see:
- Human regulatory: Pre-authorisation guidance
- Veterinary regulatory: Pre-submission guidance
- Relocation to Amsterdam
EMA holds pre-submission meetings for scientific advice exclusively by teleconference as of September 2018.
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 (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)