ANSES released on 14 March 2024 a Note setting out the criteria it takes into account when allocating specification dossiers between Member States. Pursuant to Article […]
The European commission has launched a public consultation from 22 November to 20 December 2023 on a draft Commission Regulation to define the data requirements for […]
In May 2021, the Commission published a revision of the working guidance document SANCO Doc 6621-99 initiated in 1994 and relating to the scope and limits […]
The Transparency Regulation (EU) 2019/1381 entered into force on 27 March 2021. From this date, new rules apply as regards the confidentiality of dossiers. The applicants […]