Three recent judgments handed down by the Central Administrative Courts Nos. 4, 10 and 2 on 30 March, 14 May 2021 and 27 May 2021 (ordinary proceedings Nos. 26/2019, 27/2019 and 26/2019), respectively, shed light on the data exclusivity and, in particular, on the consequences of the use and re-use of data from clinical trials or pre-clinical studies within the framework of a marketing authorisation dossier for a medicinal product (hereinafter, "MA").
These judgments establish that the use of data...
June 14, 2021
8 min read
