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European Commission and EMA Guidance to UK Marketing Authorisation Holders Regarding Brexit

The European Commission and European Medicines Agency (EMA) have jointly issued a document titled “Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use.” In this document the Commission reminds companies that from midnight on 30 March 2019, the UK will leave the EU and become a “third country.” The notice continues as follows:

In this regard, marketing authorisation holders of centrally authorised medicinal products for human and veterinary use are reminded of certain legal repercussions, which need to be considered:

  • EU law requires that marketing authorisation holders are established in the EU (or EEA);
  • Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.

Preparing for the withdrawal is therefore not just a matter for European and national administrations, but also for private parties. Marketing authorisation holders may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union.

Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union.

In particular, the Commission and the European Medicines Agency expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework.

The Commission and the European Medicines Agency stand ready to support marketing authorisation holders and will provide a series of Q&As. A dedicated page of the Agency’s website already contains general information pertaining to the outcome of the UK referendum. This page will be updated with further practical information and relevant Q&As, from May 2017 and will be subsequently expanded, where necessary.

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