Orphacol ruling a blow for European Commission, but brings some legal clarity
This article was originally published in SRA
Executive Summary
The EU's General Court has annulled a decision by the European Commission to deny approval of Orphacol, a cholic acid-containing orphan drug for rare liver diseases produced by the French firm Laboratoires CTRS1. Among other things this means that the product can now receive an EU marketing authorization (MA).
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