EMA Surveys Drugmakers on Brexit Preparedness

Posted 24 January 2018 | By Michael Mezher 

EMA Surveys Drugmakers on Brexit Preparedness

EMA says the goal of the survey is to identify companies that will require the most effort to make the necessary adjustments and transitions ahead of Brexit and to assist it and the European Commission in allocating resources to handle the additional workload.

The survey could provide a way to spur companies that have not begun preparations for Brexit to do so promptly.

According to EMA, more than a third (427/1165) of centrally authorized products on the EU market are made by UK-based drugmakers, and more than a quarter of centrally authorized products have a qualified person for pharmacovigilance (QPPV) based in the UK. EMA also says that 18% of the small and medium-sized enterprises registered with the agency are based in the UK.

Figure 1. Centrally Authorized Products on the EU Market

EMA-Survey.jpg

In a separate notice, the European Commission writes that it and EMA "expect marketing authorization holders to prepare and proactively screen authorizations 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."

Last year, both EMA and the European Commission issued guidance on the steps UK-based drugmakers, and those with certain operations in the UK, will need to take to ensure their products can remain on the EU market after Brexit.

Specifically, UK-based drugmakers must transfer their marketing authorizations to entities established in the EU or European Economic Area (EEA) in order to continue marketing those products after Brexit. Sponsors of drugs with orphan designations will also need to transfer those designations to holders in the EU or EEA to maintain them.

EU regulations also require that drugmakers' qualified person for pharmacovigilance (QPPV) reside in the EEA and that their pharmacovigilance system master file be located in the EEA. Additionally, companies with quality control, batch release or import manufacturing sites located in the UK will need to make preparations to remain in compliance with EU regulations following Brexit.

EMA has already begun sending the survey out to UK-based drugmakers and drugmakers the agency has identified as having parts of their operations in the UK. Recipients will have until 9 February 2018 to complete the survey.

EMA, European Commission


Categories: Regulatory News

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