Brexit-Related Medicine Supply Disruptions: EMA Revises List

Regulatory NewsRegulatory News | 24 September 2018 |  By 

The European Medicines Agency (EMA) on Monday announced that the number of centrally authorized medicines (CAPs) for which there are concerns of Brexit-related supply disruptions has declined from 108 to 39 (25 human medicines and 14 veterinary medicines).

“This revision results from EMA’s follow-up activities with the marketing authorisation holders [MAHs] of the 108 medicines that were identified as deemed to be at risk of supply shortages” once the UK leaves the EU on 29 March 2019, EMA said.

The revision of the list follows an industry survey on preparedness earlier this year that revealed that for 108 medicines (88 human and 20 veterinary), EMA had serious concerns that there might be potential supply shortages.

“Over the past few months, EMA has made a concerted effort to reach out to the marketing authorisation holders of these 108 centrally authorised medicines to minimise the risk of supply issues for patients,” said Noël Wathion, EMA’s Ddeputy executive director. “This is a positive development for human and animal health, and, as regards the remaining 39 medicines, we want to take this opportunity to remind the marketing authorisation holders of these medicines to step up their planning now to protect patients and animals from non-supply.”

MAHs for over half of the 108 medicines have either taken steps to transfer their marketing authorization to an EU27 country, change their qualified person for pharmacovigilance (QPPV), relocate their pharmacovigilance system master file (PSMF), adapt their logistics, supply chains and contracts or relocate some manufacturing sites, all of which are required under EU law, according to EMA.

“While the evaluation of the risk of supply and shortages of centrally authorised medicines is on-going, all marketing authorisation holders are reminded to inform the Agency of any change of plans which may affect medicine supply to patients in Europe,” EMA said.

EMA said it will work directly with the MAHs of these products to address the outstanding issues and will discuss with scientific committees relevant mitigation measures, including recommendations on possible therapeutic alternatives to which patients could be switched if necessary.

Companies are reminded to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry published on 19 June 2018.


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