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Answer:

The Quality Overall Summary (QOS) to be included in the CEP dossier should be prepared according to the provisions described in the Notice to Applicants for Medicinal Products for human use (Volume 2B – CTD Module 2.3). Please note that the QOS should be submitted in PDF format. To help applicants, the EDQM has provided a Word template for the QOS, which should be converted into a PDF when completed.


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