Forms – Applications and submissions – 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.
- 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) - ADR Expedited Reporting Summary for ADRs Occuring During Clinical Trials [2003-03-31]
- Advance Payment Details for Master Files for Human and Disinfectant Drugs, and Certificate of Supplementary Protection Applications [2017-09-13]
- 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 (effective September 22, 2018) [2018-09-04]
- Clinical Trial Site Information Form (PDF fillable/saveable - 488 KB) [2013-12-13]
(DOC Version - 132 KB) - Details for Payment of a Drug Submission Invoice [2016-10-19]
- Drug Establishment Licence Application: Forms and Instructions (FRM-0033) [2011-04-01]
- 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 [2017-03-03]
- 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]
(DOC Version - 230 KB) - How to Pay Fees to Health Products and Food Branch (HPFB) [2016-10-19]
- Label Safety Assessment Update - Sponsor Attestation [2015-07-13]
- 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]
- Master File (MF) Application Fee Form for Human Drugs [2017-05-01]
- Mock-Up Labels and Packages Certification Form (PDF fillable/saveable - 1,159 KB) [2017-01-05]
- 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 [2018-11-30]
- Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form (PDF fillable/saveable - 431 KB) [2018-11-30]
- 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]
- 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]
(DOC Version - 40 KB) - Veterinary Drugs Application and submission Forms [2017-12-20]
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