EMA revises number of medicines with concerns on post-Brexit supply

The European Medicines Agency has revised the number of centrally authorized medicines (CAPs) for which, based on current knowledge, there are concerns of Brexit-related supply disruptions from 108 to 39.

This revision results from the EMA’s follow-up activities with the marketing authorization holders of the 108 medicines that were identified as deemed to be at risk of supply shortages once the UK leaves the European Union on March 29, 2019 in the EMA’s survey on industry preparedness earlier this year.

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) the EMA had serious concerns that there might be potential supply shortages.