Versions Compared

Old Version 4

changes.mady.by.user ZHATKIN Yurii

Saved on

compared with

New Version 5

changes.mady.by.user MONTARD Laurence

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.
Info
titleYou are here:

Breadcrumb

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 PDF format. To help applicants, the EDQM has provided a Word template for QOS can be found on the Certification web pages the QOS, which should be converted into pdf a PDF when duly completed.