UK EU law breach defines mutual recognition procedures
This article was originally published in Scrip
Executive Summary
The European Court of Justice last week judged the UK's MHRAto be in breach of EU law when it rejected Synthon's marketing application for its generic Varox (paroxetine), submitted through the mutual recognition procedure (MRP). This judgement, hailed as a victory for the generics industry, sets the limits for the way member states handle MRP applications and could even lead to new guidance.