Europe – Withdrawal of the United Kingdom and EU rules for batch testing of medicinal products

This information is addressed to the EU27 Heads of Medicines Agencies and to the Executive Director of the European Medicines Agency (EMA).
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 as from 30 March 2019, 00:00h (CET) (‘the withdrawal date’) 1
the United Kingdom will be a ‘third country’.2 3
The pharmaceutical industry has been informed early by the Commission, the European
Medicines Agency and national competent authorities about the impact of United Kingdom’s
withdrawal and the need to adapt processes and to consider changes to the terms of marketing authorisations in order to ensure their continuous validity and exploitation, once the United Kingdom has left the Union.4 This contributed to a high level of preparedness of the sector.
In particular, according to Article 51(1)(b) of Directive 2001/83/EC and Article 55(1)(b) of
Directive 2001/82/EC, medicinal products imported into the EU have to undergo quality
control testing (‘batch testing’) in the EU/EEA…