Posted Tue, 03 Dec 2024 11:43:26 GMT by Caroline Brickell
could IRIS guidance be updated so that users are fully aware of the changes to selections available in the system - we've recently been advised that:
" the transition introduces changes for Scientific Advice/Protocol Assistance that might affect your submission.  Among these changes is the simplification of the structure of the types of scientific advice and relevant fees.  As a result, there will be no more distinction between initial and follow up requests and follow ups have been deactivated".  if some additional clear guidance was provided I am sure it will reduce the number of tickets you are receiving
Posted Wed, 04 Dec 2024 10:00:05 GMT by Tarita Toufexi Ms
We are currently in the process of publishing the updated guidance document.
However, there is already information available on the following webpage, including legal basis, working arrangements and questions & answers (for Scientific Advice please refer to Annex I).
New Fee Regulation (from 1 January 2025) | European Medicines Agency (EMA)



 

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