Europe – Withdrawal of the United Kingdom and EU Rules in the Field of Good Laboratory Practice (GLP)

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. Following a request by the United Kingdom, the European Council (Article 50) agreed on 11 April 2019 to extend further the period provided for in Article 50(3) TEU until 31 October 2019.3
This means that the United Kingdom will be, as of 1 November 2019 (‘the withdrawal date’), a ‘third country’.

Preparing for the withdrawal is not just a matter for EU and national administrations but
also for private parties.

In view of the uncertainties surrounding the ratification of the Withdrawal Agreement, all
interested parties, and especially economic operators, are reminded of legal
repercussions, which need to be considered when the United Kingdom becomes a third
country.

Subject to the transition period provided for in the Withdrawal Agreement, as of the
withdrawal date the EU rules in the field of Good Laboratory Practice, and in particular
Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004
on the inspection and verification of good laboratory practice (GLP) and Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the
application of the principles of good laboratory practice and the verification of their
applications for tests on chemical substances no longer apply to the United Kingdom. This has in particular the following consequences…