EMA Expects Less Supply Disruptions Resulting from BrexitBy
The European Medicines Agency (EMA) has revised the number of centrally authorized medicines (CAPs) for which there are concerns of supply disruptions due to the UK’s exit from the European Union (EU) (i.e., Brexit) from 108 to 39. The revision results from the EMA’s follow-up activities with the marketing authorization holders of the 108 medicines that were deemed to be at risk in January 2018 from the EMA.
In January 2018, an EMA survey reported that marketing authorization holders for 58% of the 694 CAPs with an important step in their regulatory processes in the UK were on track with their regulatory planning to ensure that their marketing authorizations would remain valid once the UK leaves the EU. However, for 108 medicines (88 human and 20 veterinary), the EMA had serious concerns that there might be potential supply shortages.
After the EMA contacted the marketing authorization holders of these 108 medicines between July and September 2018, reassurance on the planning was received for what the agency deems a “significant” proportion of the medicines.
“Over the past few months, EMA has made a concerted effort to reach out to the marketing authorization holders of these 108 centrally authorized medicines to minimize the risk of supply issues for patients,” said Noël Wathion, the EMA’s Deputy Executive Director in a September 24, 2018 agency statement. “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 authorization holders of these medicines to step up their planning now to protect patients and animals from non-supply.”
The agency reports that marketing authorization holders 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. According to EU law, the marketing authorization holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) in order for a company to be able to market a medicine in the EU. The EEA consists of EU countries and also Iceland, Liechtenstein, and Norway.
For the 39 remaining products (25 human medicines and 14 veterinary medicines), the EMA is analyzing how to minimize supply disruptions and any resulting impact on public and animal health.