On 2 May 2017, the European Commission and EMA published a Notice to marketing authorisation holders (MAHs) 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’.”

In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, MAHs 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 a significant matter for European and national administrations, and also equally important 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.

In order to consider the necessary changes, a list of Questions and Answers (Q&As) related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure drafted jointly by the European Commission and EMA is available on the EMA website.

The below Practical Guidance has been developed taking into consideration that as of 30 March 2019 the United Kingdom will become a third country. As a result, MAHs and applicants of centrally authorised products for human or veterinary use need to ensure that the necessary changes are made by the 30 March 2019, unless indicated otherwise in the guidance below.

This document complements the EC-EMA Q&A to provide procedural and practical guidance regarding submission of changes and related fees.

Posted on the EMA website on 19 June 2018