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]
- Adverse Drug Reaction Reporting Form for Drugs Used in Clinical Trials (this document is available in English only) [2003-03-31]
- Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications [2022-01-21]
- Certificate of Supplementary Protection (CSP) Application Form (Effective January 6, 2021) [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 (from September 21, 2017 to September 21, 2018) [2017-09-21]
- Certificate of Supplementary Protection (CSP) Application Form (from 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]
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Drug Master File (DMF) Application Form (PDF fillable/saveable - 490 KB) [2012-03-13]
- Drug Submission - Application Fee Form for Human and Disinfectant Drugs [2021-03-31]
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Form IV: Patent List - Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 466 KB)[2014-09-12]
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Form V: Declaration re: Patent List Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 471 KB) [2017-09-21]
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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.
- 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]
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Labelling Standard and Category IV Submission Check List (PDF fillable/saveable - 406 KB) [2013-11-20]
- 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 (MF) Application Fee Form for Human Drugs [in effect April 1 2022]
- 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]
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Product Monograph Certification Form (PDF fillable/saveable - 404 KB) [2013-11-07]
- Product Monograph Translation Certification Form (PDF fillable/saveable - 403 KB) [2015-07-13]
- 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]
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Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDS) [2020-11-02]
- Submission Certificate for a NDS, SNDS, SANDS, ANDS, or NC [2020-03-23]
- Veterinary Drugs Application and submission Forms [2017-12-20]
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