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

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.

Données et ressources

Info additionnelle

Champ	Valeur
Source
Version
Producteur
Courriel de l'auteur
Mainteneur
Courriel du mainteneur
Data Level
Agreement Required
Purpose Constraints
Redistribution Allowed
AI Training Allowed
Data Steward
Title (French)	Sommaire global de la qualité - entités chimiques (Demande d'identification numérique de drogues (DDIN)) (SGQ-EC (DDIN)
Update Frequency	as_needed
Geographic Scope	[]
Criticality Level	[]
Sensitivity Level	unrestricted
Langue
Contact Person
Contact Email
Dictionnaire de données
Open Canada Date Published	2017-05-04 00:00:00
Open Canada Date Modified
Open Canada Subject	["health_and_safety"]
Open Canada Keywords	{"fr": ["résumé global de la qualité", "entités chimiques", "demandes de soumission de DIN", "soumissions de DIN"], "en": ["quality overall summary", "chemical entities", "applications for DIN submission", "DIN submissions"]}
Open Canada Collection	publication
Principal Organization
Reference Data
Official Source