Guidance for completing the Drug Submission Application Form

For Drug Identification Number applications, a separate completed HC/SC 3011 must be provided for each formulation, strength and dosage form. For all other submission types, only a separate completed Part 2 must be provided for each formulation, strength and dosage form.

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Champ Valeur
Dernière modification avril 17, 2026, 17:40 (TU)
Créé le avril 17, 2026, 17:40 (TU)
criticality_level []
geographic_scope []
open_canada_collection publication
open_canada_date_published 2022-01-06 00:00:00
open_canada_keywords {"fr": ["conseils", "remplir le formulaire de demande de présentation de drogue", "les demandes de DIN", "le formulaire de formulation", "le formulaire de concentration et de dosage"], "en": ["guidance", "completing Drug-Submission-Application Form", "DIN applications", "formulation form", "strength-and-dosage form"]}
open_canada_subject ["health_and_safety"]
sensitivity_level unrestricted
title_fr Directives sur la façon de remplir le formulaire de présentation pour les médicaments
update_frequency as_needed