EMA Has Concerns Over Some Drug Firms' Readiness for Brexit

Peter Russell

July 11, 2018

A recent survey of the pharmaceutical industry carried out by the European Medicines Agency (EMA) identified concerns over some manufacturers' preparedness for Brexit.

It revealed that marketing authorisation holders for 58% of centrally authorised products with at least one important step in their regulatory processes in the UK, were "on track with their regulatory planning" to ensure that their marketing authorisation remained valid once the UK leaves the European Union (EU).

Complying With EU Rules

The centralised authorisation process allows pharmaceutical companies to submit a single marketing authorisation application to the EMA to make a medicine available throughout the EU. However, in the absence of any transitional arrangement in a withdrawal agreement, EU rules governing medicinal products for human and veterinary use would no longer apply to the UK after Brexit.

In May 2017, the European Commission warned companies of the need to prepare for the UK becoming a 'third country' a nation with which the EU has a relationship, despite no longer being a member state. EU law says that the marketing authorisation holder, the qualified person for pharmacovigilance (QPPV), or the medicine's information database, known as the pharmacovigilance system master file (PSMF), must be based in the European Economic Area (EEA) for a manufacturer to be able to market a medicine in the EU.

The Commission urged companies to prepare in advance for Brexit by ensuring these changes were made and adapting their logistics, manufacturing sites, supply chains and contracts if necessary, to ensure a continuous supply of medicines in the EU.

'Serious Concerns' for Supplies of Some Medicines

The EMA found that for the 16% of centrally-authorised medicines that are manufactured only in the UK, there were "serious concerns" that the necessary action would not be completed in time ahead of the UK's planned withdrawal from the EU. As a consequence, supplies of 88 human and 20 veterinary medicines might be disrupted in the EU unless the companies took action, it said.

As part of its Brexit preparations, the EMA contacted more than 180 marketing authorisation holders of 694 human and veterinary centrally authorised medicinal products that had a manufacturing or regulatory process in the UK on their post-Brexit plans. Over 90% of companies responded to the survey which was launched at the end of January 2018.

Relocation of the EMA 'Will Add to Workload'

The EMA said it would work with the 10% of companies that had not responded to the survey, as well as those that did not expect to carry out the necessary changes required by March 30, 2019. It would also monitor the submission of changes to marketing authorisations for all 694 products.

The EMA said it expected the majority of changes to come in the last quarter of 2018 and the first quarter of 2019 and added that this would be a particularly challenging period for the Agency as it coincides with relocation of its headquarters from the UK to the Netherlands.

It "strongly advised" pharmaceutical companies to submit the necessary changes for the continued maintenance of their marketing authorisations to the EMA before the end of the year to ensure processing takes place before the UK's withdrawal from the EU.


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