Guidance for completing the Drug Submission Application Form

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. 2023-09-01 Health Canada open-ouvert@tbs-sct.gc.ca Health and Safetyguidancecompleting Drug-Submission-Application FormDIN applicationsformulation formstrength-and-dosage form Guidance for completing the Drug Submission Application FormHTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/forms/guidance-completing-drug-submission-application-form.html Guidance for completing the Drug Submission Application FormHTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/formulaires/directives-facon-remplir-formulaire-presentation.html

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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