EUROPE – EFSA: “Transparency Regulation” – Updated Question and Answers on Practical Arrangements

Published by Adrien Margerit at 25 September 2023

To ease the implementation of the “Transparency Regulation” ((EU) 2019/1381) and of the associated detailed Practical Arrangements (PAs) (i.e. binding rules), EFSA released on 30 March 2021 a Questions and Answers document providing answers to questions frequently asked by EU Member States and stakeholders on these PAs.

On 28 August 2023, the Questions and Answers document was updated, based on the experience gained from more than two years of implementation of PAs. The updates concern arrangements on the pre-submission phase and on the Notification of Studies.

The main changes are highlighted in grey and listed in Annex 1.

To download:

Questions And Answers On The Efsa Practical Arrangements (update 28 August 2023)

See also our previous articles:

EUROPE – COM: New renewal procedure for active substances

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