Forms: Applications and submissions for drug products
For industry information about COVID-19, visit our COVID-19 Drugs and vaccines section.
To use an electronic form, you must first download the form to your computer and then use Adobe Reader or Adobe Acrobat software, latest version, to successfully complete the PDF fillable form. The Adobe Reader software is available for free on the Adobe website.
- 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]
- Details for Payment of Invoice (formerly Details of Payment of a Drug Submission Invoice) [2020-03-23]
- Drug Establishment Licence Application Form (FRM-0033) [2020-03-23] [in effect April 1, 2020]
- Drug Identification Number (DIN) Submission Certification for Human and Disinfectant Drugs (PDF fillable/saveable - 412 KB) [2017-03-24]
(Microsoft Word version - 43 KB) - Form IV: Patent List - Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 466 KB)[2014-09-12]
(Microsoft Word version - 64 KB) - Form V: Declaration re: Patent List Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 471 KB) [2017-09-21]
(Microsoft Word version - 58 KB) - Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation [2022-03-02]
Please note that, as of October 1, 2022, the 3011 should no longer be used for applications for pharmaceutical, biologic and radiopharmaceutical drugs for human and veterinary use as well as disinfectants, pursuant to Part C, Division 1 and Division 8 of the Food and Drug Regulations. Instead, please use the Regulatory Enrolment Process.
(Microsoft Word version - 147 KB) - Third Party Authorization Form (PDF version - 249 KB) [2024-09-11]
(Microsoft Word version - 107 KB) - How to Pay Fees for Health Products (formerly How to Pay Fees to Health Products and Food Branch (HPFB)) [2020-03-23]
- Label Safety Assessment Update - Sponsor Attestation [2015-07-13] [in effect until March 31, 2020]
- Sponsor Attestation S(A)NDS for Generic Drugs - Product Monograph Update to be line with the CRP form (formerly Label Safety Assessment Update - Sponsor Attestation) [2020-03-23] [in effect April 1, 2020]
(Microsoft Word version - 143 KB) - Labelling Standard and Category IV Submission Check List (PDF fillable/saveable - 406 KB) [2013-11-20]
(Microsoft Word version - 43 KB) - Labels and Packages Certification Form for Non-prescription Drugs [2020-03-23] [in effect April 1, 2020]
- Labels and Packages Certification Form for Prescription Products [2020-12-21]
- Master File Application Form [2024-10-09]
Download stylesheet ZIP file - Non-prescription drug monograph attestation form (PDF fillable/saveable - 648 KB) [2016-01-15]
- Notice - Updated Screening Criteria for Generic Drug Submissions [2013-01-09]
- Updated - Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form - Notice [2019-07-31]
- Product Monograph Certification Form (PDF fillable/saveable - 404 KB) [2013-11-07]
(Microsoft Word version - 43 KB) - Product Monograph Translation Certification Form (PDF fillable/saveable - 403 KB) [2015-07-13]
(Microsoft Word version - 43 KB) - Protocol Safety and Efficacy Assessment Template: Clinical Trial Application [2020-09-30]
- Qualified Investigator Undertaking [2020-05-27]
- Research Ethics Board Attestation [2020-12-21]
- Schedule A Form for Nonprescription Products (excluding Natural Health Products) (PDF fillable/saveable - 404 KB) [2013-11-18]
- Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDS) [2020-11-02]
(Microsoft Word version - 170 KB) - Submission Certificate for a NDS, SNDS, SANDS, ANDS, or NC [2020-03-23]
(Microsoft Word version - 37 KB) - Veterinary Drugs Application and submission Forms [2017-12-20]
Page details
- Date modified: