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BioTalk

2 results for: marketing authorisation

09 Oct, 2024

Case C-237/22 of the CJEU – Clarification of the concepts of “Significant Benefit” and “Clinical Superiority”

By Marc Martens Benedicte Mourisse

The CJEU brings clarity, on the concepts of “Significant Benefit” and “Clinical Superiority” with respect to Orphan Medicinal Products...

09 Aug, 2023

By Sophie Vo Sally Shorthose

This article is part of a series that covers the proposed reforms to EU pharmaceutical legislation. To view our first article and the...