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Some pharma companies not prepared for Brexit, warns EMA

Regulator concerned about medicines shortages after March 2019


The European Medicines Agency has warned that some companies could be caught out by Brexit, with supply shortages of some medicines likely if action isn’t taken soon.

The UK is set to the leave the European Union on 29 March 2019, and as the  arrangements for a transition period are yet to be finalised, the EU medicines regulator says pharma companies should take this as their deadline date for regulatory changes.

Companies have to plan for the UK becoming a ‘third country’ to the EU, which means updating any centrally authorised products (CAP) marketing authorisations which have a crucial step registered in the UK.

Examples of this could include changes to the marketing authorisation itself, such as a transfer of the marketing authorisation to a legal entity established in the European Economic Area (EEA), a change of the qualified person for pharmacovigilance (QPPV) or pharmacovigilance system master file (PSMF) to a location in the EEA.

There may also need to be adaptations to a company’s logistics, manufacturing sites, supply chains and contracts – costly and complicated procedures which are normally carried out over a period of several years.

The EMA says its survey of marketing authorisation holders found that more than half (58%) of the 694 CAPs with an important step in their regulatory processes in the UK were on track to ensure their licences remains valid – but have raised concerns about a small group of companies and products.

It says 108 (88 human products and 20 veterinary products), or 16%, of these medicines with manufacturing sites located in the UK only, “there are serious concerns that the necessary actions will not be carried out in time.”

Most worryingly, for 10% of the products included in the survey, EMA received no feedback from companies.

The agency says it is liaising directly with companies who either did not reply to the survey or have indicated that they don’t plan to submit the changes required by 30 March 2019 and have manufacturing sites in the UK only, as this could clearly lead to supply disruptions.

The EMA say it will look to identify those products at greatest risk of supply shortages, and those most critical to medical care.

It concluded: “EMA urges those companies who have not yet informed EMA of their Brexit preparedness plans to do so as soon as possible to mitigate any risks to the continuous supply of medicines for human and veterinary use within the EU.”

The UK pharma industry association the ABPI says it is currently formulating its response to the EMA's announcement this morning.

The EMA is itself in the midst of its own massive upheaval thanks to Brexit: it is in the process of moving to Amsterdam. However the complexity of this undertaking means the move won’t be complete by April 2019, as EMA staff will have to use temporary offices because its permanent new office block in the Zuidas district is still under construction - and would not be able to accommodate all 890 staff and provide room for meetings until the very end of 2019 at the earliest.

The EMA has pledged that the relocation won’t disrupt its activities, most especially the approval of new medicines for humans.

Article by
Andrew McConaghie

11th July 2018

From: Regulatory



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