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Brexit: Regulatory Impact

Brexit Regulatory Impact

Introduction

On 29 March 2017, the United Kingdom notified the European Council of its intention to withdraw from the European Union, a process known as “Brexit”. As a consequence of this, the European Medicines Agency (EMA) relocated from London to Amsterdam, and the United Kingdom will become a “third country” starting 30 March 2019.

 

Regulation of medicines

Pharmaceutical companies are requesting a progressive transition in the regulation of medicines, in order not to interrupt medical supply and to protect public and animal health once the United Kingdom withdraws from the European Union.

In response to this demand, the EMA has published guidance to help pharmaceutical companies prepare for the changes affecting medicines with marketing authorisations granted under the centralised procedure, both for human and veterinary use. The purpose of this guidance is to ensure that pharmaceutical companies are prepared to take the necessary steps to ensure an uninterrupted supply of their medicines, in the interest of patients.

On 1 December 2017, an updated version of the Questions and Answers document included in this guidance was published, providing information on the different application changes resulting from Brexit and related fees, such as transferring authorisations granted under the centralised procedure to companies established in the UE, manufacturing sites located in the EU, batch releases, pharmacovigilance, and so on.

In terms of authorisations granted under the decentralised procedure or under a mutual recognition agreement, the United Kingdom may no longer act as the Member State of Reference, and therefore another will have to be named.

The EMA is also preparing a series of additional documents to continue offering guidance to companies throughout the process.

Time Framework

The necessary changes to the MAHs for medicines authorised under the centralised process must be made before 30 March 2019, the date on which the United Kingdom will become a third country.

 

At Azierta, we have a team of specialists with broad experience in the regulatory environment, who can help and support you as you prepare for the arrival of these new changes.

We invite you to visit our website and ask us any questions you may have using our form https://azierta.eu/rraa/

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