EDQM FAQs
- What are the requirements for the quality of water used in the last steps of the synthesis and reported on the CEP 2.0?
- How can I get confirmation that a specific grade (e.g. micronised, milled, etc.) described in my CEP dossier is approved by the EDQM?
- How can we provide two distinct sections (3.2.S.4.2) in our eCTD* sequences?
- 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?
- 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?
- What will be the procedure for deleting non-approved information from the dossier?