Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submissions) (QOS-CE (DINA))

Description

The Quality Overall Summary (QOS) is a summary of the Quality Body of Data. This QOS-CE (DINA) template can be used by sponsors to summarize the Quality information for Applications for Drug Identification Number Submissions (DINAs) containing drug substances and their corresponding products of synthetic or semi-synthetic origin that are filed with Health Canada pursuant to Part C, Division 1 (C.01.014) of the Food and Drug Regulations.

Resources

Name Format Description Link
Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submissions) (QOS-CE (DINA)) HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/templates/quality-overall-summary-chemical-entities-applications-drug-identification-number-submissions-dina.html
Quality Overall Summary - Chemical Entities (Applications for Drug Identification Number Submissions) (QOS-CE (DINA)) HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/modeles/sommaire-global-qualite-entites-chimiques-demande-identification-numerique-drogues-ddin-ddin-modeles.html

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