Policy Issues: Filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug Submissions, Notifiable Changes and Cross-referenced Submissions

Description

The attached policy has been developed to provide for the filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug Submissions, Notifiable Changes and Cross-Referenced Submissions in some circumstances prior to the issuance of the Notice of Compliance for the original submission.

Resources

Name Format Description Link
Policy Issues: Filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug Submissions, Notifiable Changes and Cross-referenced Submissions HTML https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/policies/policy-issues-filing-supplemental-new-drug-submissions-supplemental-abbreviated-new-drug-submissions-notifiable-changes-cross-referenced-submissions.html
Policy Issues: Filing of Supplemental New Drug Submissions, Supplemental Abbreviated New Drug Submissions, Notifiable Changes and Cross-referenced Submissions HTML https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/medicaments/demandes-presentations/politiques/questions-politique-depot-presentations-supplementaires-drogues-nouvelles-supplements-presentation-abregee-drogue-nouvelle-modifications-declaration.html

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