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Almost half of UK medicines’ marketing approvals not Brexit-ready

Up to 42% of UK medicines may not be able to market their products in the European Union (EU) post-Brexit, a survey from the European Medicines Agency (EMA) has revealed.

The EMA said marketing authorisation holders for 58% of 693 centrally authorised products (CAPs) are on track to ensure they can continue to market their products once the UK leaves the EU in March 2019.

UK companies with CAPs have a single marketing authorisation (MA) issued by the European Commission (EC). They must update this authorisation to be able to continue advertising within EU states once the UK has left the EU.

The EMA said it had “serious concerns” regarding the 108 medicines (88 human and 20 veterinary) that it fears will not take the necessary actions in time.

Many of these companies will need to transfer their MA approvals or change their qualified persons to EEA established legal entities, as well as update logistics, manufacturing sites, supply chains and contracts.

The EMA survey was launched in January 2018 to identify CAPs that will be at risk of supply shortages and to obtain timelines for the necessary regulatory changes. The regulator will now work closely with those companies which are at risk.

Tom Moore, senior healthcare analyst at GlobalData, said: “[The] results published by the EMA provide some explanation as to why healthcare and pharma professionals foresee regulatory issues as being so important post-Brexit.”

Mr Moore explained that the results are in line with GlobalData’s findings, which outline regulatory issues as the more severe implication for the healthcare industry, when the UK leaves the EU.

Mark Dayan, policy and public affairs advisor at independent think tank Nuffield Trust said that the marketing authorisations for these medicines would have a greater impact on EU pharmacists, whereas EU marketing authorisations that are not prepared to continue marketing products in the UK will be more important to UK pharmacists.

Mr Dayan said: “With regards to the UK industry, it still remains overwhelmingly likely that we will have a transition period from March next year until 2021, so these issues probably will not be immediately relevant.

“However, there remains a small but perhaps growing chance of a ‘no deal’ Brexit, in which case any section of the UK pharmaceutical industry without MAs held by an entity within the EEA would not be able to sell into the EEA. There would also need to be batch control when products arrived in the EEA. All this could of course cause considerable trouble in the short term.”

A spokesperson from European Federation of Pharmaceutical Industries and Associations (EFPIA) said: “With less than a year to go till March 2019, EFPIA members continue to prepare for the contingency of a hard Brexit and the ‘no deal’ scenario.

“In February, the EFPIA president sent a letter to all members stressing the need for readiness by March 2019 and the importance of having Brexit contingency plans in place. EFPIA members took note, moving marketing authorisation holders from the UK to the EU27, moving testing facilities, working on packaging and labelling issues [and] study how to ensure supply with respect to possible customs challenges.”

He added that the EFPIA will work together with the EMA and the survey results to understand the status of companies preparedness. The spokesperson also pointed to ongoing work with the Life Sciences Coalition, and the eleven associations representing the European and British life science industry to gain additional regulatory clarity.

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