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.
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