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Image header Agence Europe
Europe Daily Bulletin No. 12103
Contents Publication in full By article 24 / 27
NEWS BRIEFS / Health

Availability of 39 other medicines threatened by Brexit

25/09/2018 (Agence Europe)The European Medicines Agency warned on 24 September that Brexit could disrupt access to 39 medicines (25 for human beings and 14 for animals) that have received a centralised marketing permit.  In July, it estimated the number would be 108 (of the 694 products with centralised authorisation). Under EU law, the marketing authorisation holder, the QPPV (person qualified for pharmacovigilance), the PSMF (permanent pharmacovigilance system file) 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.  In a press release, the agency says that for each of the 39 remaining products, the EMA is looking at how to minimise breakdowns in supply and their impact on public health. (SPj)

Contents

SECTORAL POLICIES
INSTITUTIONAL
ECONOMY - FINANCE
EXTERNAL ACTION
COURT OF JUSTICE OF THE EU
NEWS BRIEFS
CORRIGENDUM