Guidance published by the European Medicines Agency (EMA). This site comprises several links to documents published by the Commission and Heads of Medicines Agencies as well as EMA itself: Brexit-related guidance for companies.
6 March 2019 Brexit: Handling Pharmacovigilance Data from the UK
How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.
27 February 2019 Brexit: Will UK Inspection Reports and GMP Certificates still be valid?
Will EU-based pharmaceutical companies still be able to use a manufacturing site for which the GMP Certificate has been issued by a UK authority? The answer is yes - but with restrictions.
21 November 2018 Brexit: EMA to focus on Medicines Evaluation and Supervision
End of September the EMA together with the European Commission organised a meeting with industry stakeholders to discuss the UK's withdrawal from the European Union ("Brexit"). Now the report of the EMA-Industry stakeholder meeting was published.
27 June 2018 Brexit: Two new Documents published by EMA
The European Medicines Agency (EMA) has published two updated documents on U.K.´s withdrawal from the EU - giving a lot of new Questions and Answers on Brexit.
25 April 2018 Brexit: EMA appoints new rapporteurs for centralized authorizations
In the course of Brexit, the EMA has already appointed new rapporteurs and co-rapporteurs for approx. 370 centralized authorizations. Read more about EMA's procedure for appointing new rapporteurs.
3 August 2017 What does Brexit mean for the QP?
The decision of the U.K. to leave the EU has caused a high uncertainty throughout industry - and also in the pharmaceutical industry. The European QP Association has received a number of questions on what Brexit actually means for QPs. For that reason the EQPA leadership team has prepared some information.
EMA Webinar on „Brexit“ related Manufacturing and Supply:
EMA Webinar on „Brexit“ related Manufacturing and Supply On 12th December 2017 the European Medicines Agency (EMA) conducted a webinar on ““Brexit” related manufacturing and supply" – with the objective to discuss with Industry stakeholders (Human and Veterinary Industry) manufacturing and supply questions linked with Brexit preparedness activities. Industry associations were invited to forward questions in advance. David Cockburn participated in this webinar and provided a summary of the questions asked by industry associations and the answers provided by the EMA (login required).
Your "Brexit"-related Questions in the Discussion Forum: