Guidance for completing the Drug Submission Application Form

Description

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.

Resources

Name Format Description Link
Guidance for completing the Drug Submission Application Form HTML 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 Form HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/formulaires/directives-facon-remplir-formulaire-presentation.html

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