The European Medicines Agency (EMA) has revised the number of centrally authorised medicines (CAPs) for which, based on current knowledge, there are concerns of Brexit-related supply disruptions from 108 to 39. This revision results from EMA’s follow-up activities with the marketing authorisation holders of the 108 medicines that were identified as deemed to be at risk of supply shortages once the United Kingdom (UK) leaves the European Union (EU) on 29 March 2019 in EMA’s survey on industry preparedness earlier this year.
Results of the survey showed that marketing authorisation 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 authorisations would remain valid once the UK leaves the EU. However, for 108 medicines (88 human and 20 veterinary) EMA had serious concerns that there might be potential supply shortages.
After EMA contacted the marketing authorisation holders of these 108 medicines between July and September, reassurance on the planning was received for a significant proportion of these medicines.
“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 Deputy 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.”
Marketing authorisation holders for over half of the 108 medicines have either taken steps to transfer their marketing authorisation 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 authorisation 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.
For each of the 39 remaining products (25 human medicines and 14 veterinary medicines), EMA is analysing how to minimise supply disruptions and any resulting impact on public and animal health.
The Agency will work directly with the marketing authorisation holders of these products to address the outstanding issues on an ongoing basis. It will also discuss with its scientific committees relevant mitigation measures, including recommendations on possible therapeutic alternatives to which patients could be switched if necessary.
This information is being shared with participants at an industry stakeholder meeting taking place at EMA today.
Background on the survey
The aim of the EMA survey, which was launched in January 2018, was to obtain information on the timelines for submission of the necessary regulatory changes and to identify CAPs potentially at risk of supply shortages.
The survey was sent to marketing authorisation holders of the 694 CAPs (661 human and 33 veterinary products) who are located in the UK or who have quality control, batch release and/or import or manufacturing sites, or a QPPV or PSMF in the UK.
Reminder to industry on preparations for Brexit
Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU as Link}. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry as Link} published on 19 June 2018.
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.
In addition, applicants submitting new marketing authorisation applications to EMA are reminded to ensure that the arrangements they are proposing in their application remain valid after Brexit and likewise make the necessary changes by 29 March 2019.
Companies are also reminded that, if they foresee a product supply issue with a medicine, they have a legal obligation to inform EMA.