On 2 May 2017, the European Commission and EMA published a Notice to marketing authorisation holders of centrally authorised medicines products for human and veterinary use, which was updated on 29 January 2018. The Notice states: “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 a ratified withdrawal agreement establishes another date, 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’.

In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, marketing authorisation holders of centrally authorised medicinal products for human and veterinary use are reminded of certain legal consequences that need to be considered in a timely manner. Preparing for the consequences of the UK’s withdrawal from the Union is not just a matter for EU and national authorities, but also for private parties. Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, the EU rules in the field of medicinal products for human and veterinary use no longer apply to the United Kingdom.

This list of Questions and Answers (Q&As) has been drafted jointly by the European Commission and EMA. This version is an update of the initial list of Q&As published on 31 May 2017 and it replaces that initial list of Q&As. The new text introduced in the version of Q&As “Rev 01” published on 1 December 2017 is indicated by the word “NEW”. The version “Rev 02” published on 29 January 2018 does not amend the Q&A, but consists of a technical revision of the introductory text on page 1 to introduce standardised wording across all sectorial guidance documents. The Q&As may be further updated and complemented in the future. The advice below applies equally to medicinal products for human or veterinary use, unless otherwise indicated in the heading to the question.

Posted on the EMA website on 29 January 2018