Questions and Answers on EFSA Practical Arrangements

The “Questions and Answers on EFSA Practical Arrangements” provides answers to questions frequently asked  on Practical Arrangements (PAs) formulated by EU Member States and stakeholders in the context of the engagement linked to the implementation of the Transparency Regulation prior to its entry into application and completes the feedback cycle on the Practical Arrangements published in January 2021. On 28 August 2023, the Questions and Answers document has been updated, based on the experience gathered after more than two years of implementation.  This new version concerns the arrangements of the pre-submission phase and introduces updates relevant to the Notification of Studies. The main changes are highlighted with a grey shading and listed in Annex 1 to the Q&A document. 

Questions on the interpretation of the provisions of the Transparency Regulation are out of the scope of this document, which exclusively focuses on the EFSA Practical Arrangements.