Title: CEP 2.0 and content of the application  
Author: MONTARD Laurence Jul 21, 2023
Last Changed by: MONTARD Laurence Jul 21, 2023
Tiny Link: (useful for email) https://faq.edqm.eu/x/KoBvB
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    Page: CEP 2.0
Children (6)
    Page: What are the requirements for the quality of water used in the last steps of the synthesis and reported on the CEP 2.0?
    Page: How can I get confirmation that a specific grade (e.g. micronised, milled, etc.) described in my CEP dossier is approved by the EDQM?
    Page: How can we provide two distinct sections (3.2.S.4.2) in our eCTD* sequences?
    Page: CEP 2.0 requires maximum daily dose (MDD), route of administration and treatment duration to be provided in S.1.3. However, these characteristics do not apply to active ingredients. What should I do?
    Page: Is it possible to apply for a re-test period when only 3 months of accelerated/long-term stability studies are available at the time of the original submission?
    Page: What will be the procedure for deleting non-approved information from the dossier?
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Time Editor  
Jul 21, 2023 10:43 MONTARD Laurence