Forms: Applications and submissions for drug products
The electronic forms below require the use of 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.
- Serious adverse drug reaction reporting form for hospitals [2019-06-26]
- Template authorizing unrestricted sharing of information [2018-06-22]
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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 Drug Submissions and Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications [2017-09-13] [in effect until March 31, 2020]
- Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications [2020-03-23] [in effect April 1, 2020]
- Certificate of Supplementary Protection (CSP) Application Form (Effective April 1, 2020) [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) [2020-05-27]
- Details for Payment of a Drug Submission Invoice [2016-10-19] [in effect until March 31, 2020]
- Details for Payment of Invoice (formerly Details of Payment of a Drug Submission Invoice) [2020-03-23] [in effect April 1, 2020]
- 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 [2020-03-23] [in effect April 1, 2020]
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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 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, 2020, the 3011 should no longer be used for applications for pharmaceutical, biologic and radiopharmaceutical drugs for human 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 - 228 KB)
- Guidance for Completing the Drug Submission Application Form [2020-05-27] [in effect April 1, 2020]
- How to Pay Fees to Health Products and Food Branch (HPFB) [2016-10-19] [in effect until March 31, 2020]
- How to Pay Fees for Health Products (formerly How to Pay Fees to Health Products and Food Branch (HPFB)) [2020-03-23] [in effect April 1, 2020]
- 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 (PDF fillable/saveable - 1,006 KB) [ 2019-07-25] [in effect until March 31, 2020]
- Labels and Packages Certification Form for Prescription Products [2020-04-22] [in effect April 1, 2020]
- Master File (MF) Application Fee Form for Human Drugs [2019-08-14]
(PDF fillable/saveable - 894 KB) Please download form to your desktop before filling out. [in effect until March 31, 2020]
(DOC Version - 50 KB) - Master File (MF) Application Fee Form for Human Drugs [2020-03-23] [in effect April 1, 2020]
- 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]
- Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form (PDF fillable/saveable - 435 KB) [2019-10-03] Please download form to your desktop before filling out. [in effect until March 31, 2020]
- Post-Notice of Compliance (NOC) Changes: Notice of Change: (Level III) Form [in effect April 1, 2020]
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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 [2020-05-27]
- Right to Sell Drugs Fee Remission Request and Attestation Form [2011-06-01] [in effect until March 31, 2020]
- 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) [2017-10-30]
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Submission Certification for NDS, SNDS, SANDS, ANDS and NC (PDF fillable/saveable - 413 KB) [2016-01-15] [in effect until March 31, 2020]
- Submission Certificate for a NDS, SNDS, SANDS, ANDS, or NC [2020-03-23] [in effect April 1, 2020]
- Veterinary Drugs Application and submission Forms [2017-12-20]
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