Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU
EMA and the European Commission publish first in a series of Q&As for companies
The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.
The questions-and–answers document concerns information related to the location of establishment of a company in the context of centralised procedures and certain activities, including the location of orphan designation holders, qualified persons for pharmacovigilance (QPPVs) and companies’ manufacturing and batch release sites.
EMA is preparing a series of further guidance documents which will be published on its website in due course. Companies are advised to regularly check EMA’s dedicated webpage on the consequences of Brexit.
This first questions-and-answers document follows the publication of the European Commission/EMA notice to marketing authorisation holders of centrally authorised medicines for human and veterinary use on 2 May 2017.
Latest News from
European Banking Authority to be relocated to Paris, France22/11/2017 16:15:00
The EU 27 ministers recently selected Paris, France, as the new seat for the European Banking Authority (EBA).
European Medicines Agency to be relocated to Amsterdam, the Netherlands22/11/2017 15:05:00
The EU 27 ministers recently selected Amsterdam, the Netherlands, as the new seat for the European Medicines Agency (EMA).
EU to beef up cybersecurity22/11/2017 14:15:00
The General Affairs Council has adopted conclusions calling for the strengthening of European cybersecurity and enhancing cyber resilience across the EU, in line with the tasking from the European Council in October 2017.
2018 EU budget: Agreement reached22/11/2017 13:20:00
On 18 November 2017, the Council and the European Parliament reached agreement on an EU budget for 2018 that strongly reflects the EU's main policy priorities.