Forms: Applications and submissions for drug products

For industry information about COVID-19, visit our COVID-19 Drugs and vaccines section.

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• Sponsor Attestation: SNDS for Biosimilar Products - Addition of Indication to Product Monograph to be in line with the Innovator Product [2022-07-27]
• Medical Device Foreign Risk Notification [2022-06-10]
• Serious adverse drug reaction reporting form for hospitals [2019-06-26]
• Template authorizing unrestricted sharing of information [2018-06-22]
• Administrative Changes - Certification Form for Human and/or Disinfectant Drug Submissions and Applications (PDF fillable/saveable - 433 KB) [2018-12-18]
  (Microsoft Word version - 59 KB)
• Adverse Drug Reaction Reporting Form for Drugs Used in Clinical Trials (this document is available in English only) [2003-03-31]
• Certificate of Supplementary Protection (CSP) Application Form (Effective November 16, 2023) [2023-11-16]
• Certificate of Supplementary Protection (CSP) Application Form (Effective January 6, 2021 to November 15, 2023) [2021-01-06]
• Certificate of Supplementary Protection (CSP) Application Form (Effective April 1, 2020 to January 5, 2021) [2020-04-01]
• Certificate of Supplementary Protection (CSP) Application Form (Effective September 21, 2017 to September 21, 2018) [2017-09-21]
• Certificate of Supplementary Protection (CSP) Application Form (Effective September 22, 2018 to May 14, 2019) [2019-05-15]
• Certificate of Supplementary Protection (CSP) Application Form (Effective May 15, 2019 to March 31, 2020) [2019-05-15]
• Clinical Trial Site Information Form (Effective January 2, 2020) (PDF fillable/saveable - 233 KB) [2022-01-13]
  • Instructions for completing the Clinical Trial Site Information Form [2020-05-27]
  • Guidance for Completing the Drug Submission Application Form [2020-05-27]
  • Post-Notice of Compliance (NOC) Changes: Notice of Change: (Level III) Form

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  Date modified: 2024-06-17