During May 2017, the European Commission and EMA published a Notice to marketing authorisation holders of centrally authorised medicines products for human and veterinary use, stating: “The United Kingdom submitted on 29 March 2017 the notification of its intention to withdraw from the Union pursuant to Article 50 of the Treaty on European Union. This means that unless the withdrawal agreement establishes another date or the period is extended by the European Council in accordance with Article 50(3) of the Treaty on European Union, all Union primary and secondary law ceases to apply to the United Kingdom from 30 March 2019, 00:00h (CET). The United Kingdom will then become a 'third country'.”
This has been followed up with a question-and-answer (Q&A) document concerning 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.
The current situation is that, from 30 March 2019, pharmacovigilance activities which must take place in an EU member state will no longer be able to be conducted in the UK. Quanticate will continue to monitor developments through the close involvement of our highly experienced PV team with expert industry bodies and frequent interactions with regulatory agencies. Quanticate will ensure rapid responses to the changing regulatory landscape to minimise the impact of Brexit for existing and new clients. Our EU offices also have us well placed for any necessary transition of activities in the short or longer term.
We trust that the ongoing talks between the UK and EU will be constructive and keep patients at the forefront of discussions, ensuring access to new medicines is not delayed and the huge efforts towards pharmacovigilance harmonisation, improving patient safety, are not undone.