The European Medicines Agency (EMA) has announced that the number of centrally authorised medicines for which there are concerns of Brexit-related supply disruptions has declined from 108 to 39 (25 human medicines and 14 veterinary medicines).
The revision is as a result of the EMA’s follow-up activities with the marketing authorisation holders (MAHs) of the 108 medicines that were identified as a potential risk of supply shortages when the United Kingdom (UK) leaves the European Union (EU) on 28th March 2019.
“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”. With regards to the remaining 39 medicines, the EMA is planning to remind the MAHs of these medicines to step up their planning now to protect patients and animals from non-supply. The EMA plans to work directly with the MAHs of these products to address any outstanding issues, and will discuss with scientific committees the relevant mitigation measures.
Many MAHs have already 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, all of which are required under EU law, according to EMA.
The EMA advises companies to regularly check the EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU, and to check the updated questions and answers, and practical guidance for industry published on 19 June 2018.
To read more about how companies are stepping up their efforts to ensure medicine supply post Brexit, please click here.