Forms on applications and submissions for drug products
Some documents are only available by request and are labeled as "available upon request". When you select one of those links, an email message will open with the required information already filled in. Simply 'Send' the message. Alternatively, you can also email the address provided for each document and include the subject line specified in the list below.
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.
- Consent letter authorizing sharing of information with health technology assessment organizations (PDF fillable/saveable - 219 KB) [2026-01-16]
- Risk management plan summary attestation/acknowledgment form [2025-09-03]
- Notifying Health Canada of Foreign Actions in respect of a Serious Risk of Injury to Human Health [2023-08-31]
- Medical Device Foreign Risk Notification [2022-06-10]
- Serious adverse drug reaction reporting form for hospitals [2019-06-26]
- 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 October 28, 2025)
- Certificate of Supplementary Protection (CSP) Application Form (Effective November 16, 2023 to October 27, 2025) [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 September 14, 2026) (fillable/saveable PDF, 198 KB) [2026-09-14]
- 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 - 514 KB) [2026-08-06]
(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 - 121 KB) [2025-09-10]
(Microsoft Word version - 85 KB) - How to Pay Fees for Health Products (formerly How to Pay Fees to Health Products and Food Branch (HPFB)) [2020-03-23]
- Sponsor attestation S(A)NDS labelling only (generic drugs) – Product monograph (PM) updates to align with the Canadian reference product (CRP) (available upon request at no-reply.rpmd-dgpr.non-response@hc-sc.gc.ca). The subject line must read "Request for Sponsor Attestation Supplemental (Abbreviated) New Drug Submission (S(A)NDS) Labelling only (generic drugs)". [2026-05-01]
- 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 [2025-06-30]
- Master File Application Form [2025-11-05]
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]
- Post-Notice of Compliance (NOC) Changes: Notice of Change: (Level III) Form
- 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 (ANDSs) (available upon request at no-reply.rpmd-dgpr.non-response@hc-sc.gc.ca). The email subject line must read "Request for Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDSs)". [2026-05-01]
- 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]
- Ministerial Reliance Order: Sponsor's Request and Attestation Form for Human Drugs (available upon request at no-reply.rpmd-dgpr.non-response@hc-sc.gc.ca). The subject line must read "Request for Ministerial Reliance Order: Sponsor's Request and Attestation Form for Human Drugs ". [2026-07-15]