UK EU law breach defines mutual recognition procedures
This article was originally published in Scrip
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.
You may also be interested in...
Pharmaceutical industry groups say the European Commission’s Pharmaceutical Strategy Roadmap lacks detail on delivering a faster regulatory process and encouraging competitiveness.
The Australian Therapeutic Goods Administration is consulting on a draft standard for data matrix codes on the labels of certain medicines.
The European Medicines Agency received more requests for scientific advice in 2019 than it did in 2018. Meanwhile, requests for advice in other areas has fallen.