EDQM: Guidance for electronic submissions of CEP applications revised
In July 2021, EDQM published a revised version of the document "Guidance for electronic submissions for Certificates of Suitability (CEP) applications" (PA/PHCEP (09) 108). This guidance includes the current requirements for how an application for Certificates of Suitability must be conducted in eCTD format.
The guideline now includes new provisions for the conversion from another format to the eCTD format, which is mandatory for most monographs of the European Pharmacopoeia: Thus, " it will be mandatory to include any information already assessed and approved previously in a “baseline (full dossier)” to facilitate the lifecycle management of the dossier." The deadline for this is January 2022.
Furthermore, some explanations on specific topics have been added. According to EDQM, the changes are intended to simplify the application process.
Source:
EDQM: Guidance for electronic submissions for Certificates of Suitability (CEP) applications
EDQM: Newsroom
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