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The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.
On Sept. 24, 2018, the European Medicines Agency (EMA) announced that it revised the number of centrally authorized medicines (CAPs) for which there are concerns over Brexit-related supply disruptions from 108 to 39.
This revision results from EMA’s follow-up activities with the marketing authorization holders of the 108 medicines that were identified to be at risk of supply shortages once the United Kingdom (UK) leaves the European Union (EU) on March 29, 2019 in EMA’s survey on industry preparedness, announced in January 2018.
Results of the survey showed 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) EMA reports that it had serious concerns that there might be potential supply shortages.
After EMA contacted the marketing authorization holders of these 108 medicines between July and September 2018, the agency received reassurance regarding planning for a significant percentage of these 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, EMA’s deputy executive director, in an agency press release. “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.”
Marketing authorization holders for over half of the 108 medicines have either taken steps to transfer their marketing authorization to an EU27 country, or one of 27 EU countries involved in Brexit negotiations except for the UK; 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 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 analyzing how to minimize supply disruptions and any resulting impact on public and animal health.
According to the agency, it will work directly with the marketing authorization holders of these products to address outstanding issues on an ongoing basis. It will also discuss relevant mitigation measures with its scientific committees, including recommendations on possible therapeutic alternatives patients could be switched to, if necessary.
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 authorization 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.
Companies are reminded to plan for the UK’s withdrawal from the EU on March 29, 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA also encourages companies to refer to the updated questions and answers and practical guidance for industry published in June 2018.
While the evaluation of the risk of supply and shortages of centrally authorized medicines is on-going, all marketing authorization 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 authorization 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 March 29, 2019,” the agency stated in the release. “Companies are also reminded that, if they foresee a product supply issue with a medicine, they have a legal obligation to inform EMA.”