Forms – Applications and Submissions – Drug Products
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- Guidance for Completing the Drug Submission Application Form (applicable on or after April 1st, 2019) [2020-03-20]
- 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]
(DOC Version - 59 KB) - 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 (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) [2019-05-15]
- Clinical Trial Site Information Form (Current 2013-2019) (PDF fillable/saveable - 488 KB) [2013-12-13] (DOC Version - 132 KB)
- Clinical Trial Site Information Form (Effective January 2, 2020) (PDF fillable/saveable - 231 KB) [2019-12-18]
- 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: Forms and Instructions (FRM-0033) [2011-04-01] [in effect until March 31, 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]
(DOC Version - 43 KB) - Drug Master File (DMF) Application Form (PDF fillable/saveable - 490 KB) [2012-03-13]
(DOC Version - 38 KB) - Drug Submission - Application Fee Form for Human and Disinfectant Drugs [2019-03-15] [in effect until March 31, 2020]
- Drug Submission – Application Fee Form for Human and Disinfectant Drugs [2020-03-23] [in effect April 1, 2020]
- Form IV: Patent List - Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 466 KB)[2014-09-12]
(DOC Version - 64 KB) - Form IV: Patent List - Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 466 KB)[2014-09-12]
(DOC Version - 64 KB) - Form V: Declaration re: Patent List Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable - 471 KB) [2017-09-21]
(DOC Version - 58 KB) - Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation (PDF fillable/saveable - 626 KB) [2019-01-07] [in effect until March 31, 2020]
(DOC Version - 230 KB)- Guidance Document: Health Canada 3011: Drug Submission Application Form for: Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation [2019-01-03] [in effect until March 31, 2020]
- Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation [2020-03-23] [in effect April 1, 2020]
- Guidance for Completing the Drug Submission Application Form [2020-03-23] [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]
- Labelling Standard and Category IV Submission Check List (PDF fillable/saveable - 406 KB) [2013-11-20]
(DOC Version - 43 KB) - Labels and Packages Certification Form for Non-prescription Drugs [2018-02-06] [in effect until March 31, 2020]
- 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 [2020-03-23] [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] - Master File (MF) Application Fee Form for Human Drugs [2020-03-23] [in effect April 1, 2020]
(DOC Version - 50 KB) - 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]
- Product Monograph Certification Form (PDF fillable/saveable - 404 KB) [2013-11-07]
(DOC Version - 43 KB) - Product Monograph Translation Certification Form (PDF fillable/saveable - 403 KB) [2015-07-13]
(DOC Version - 43 KB) - Qualified Investigator Undertaking [2016-04-14]
- Research Ethics Board Attestation [2016-04-14]
- 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]
(DOC Version - 43 KB) - Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDS) [2017-10-30]
(DOC Version - 170 KB) - Submission Certification for NDS, SNDS, SANDS, ANDS and NC (PDF fillable/saveable - 413 KB) [2016-01-15] [in effect until March 31, 2020]
(DOC Version - 40 KB) - Submission Certificate for a NDS, SNDS, SANDS, ANDS, or NC (PDF) [2020-03-23] [in effect April 1, 2020]
DOC Version - Veterinary Drugs Application and submission Forms [2017-12-20]
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