Health Canada
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Drugs and Health Products
Forms
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
The electronic forms below require the use of the latest version of Adobe Reader or Adobe Acrobat software, to successfully complete the PDF fillable form. The Adobe Reader software is available for free on the 
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- ADR Expedited Reporting Summary for ADRs Occuring During Clinical Trials [2003-03-31]
- Animal Tissue: Labelling Standard [2010-10-26]
- Certification: Submissions NDS, SNDS, NC (PDF fillable/saveable (413 K)) [2016-01-15]
(DOC Version - 40 K) - Changes in Manufacturer/Sponsor Name and/or Product Name: Administrative Changes - Certification Form for Human, Veterinary or Disinfectant Drugs (PDF fillable/saveable (419 K)) [2016-04-21]
(DOC Version - 45 K) - Clinical Trial Site Information Form (PDF fillable/saveable (488 KB)) [2013-12-13]
(DOC Version - 38 K) - Drug Establishment Licence Application:Forms and Instructions (FRM-0033) [2011-04-01]
- Drug Identification Number (DIN) Submission Certification (PDF fillable/saveable (412 KB)) [2013-11-29]
(DOC Version - 43 K) - Drug Master File (DMF) Application Fee Form (PDF fillable/saveable (882 KB)) [2016-04-01]
(DOC Version - 68 K)
- How to Pay Fees to Health Products and Food Branch (HPFB) [2016-04-01]
- Advance Payment Details for Drug Submissions and Master Files (PDF fillable/saveable (1.7 MB)) [2016-04-01]
- Drug Master File (DMF) Application Form [2012-03-13]
- Drug Product Information Form [2007-06-21]
- Drug Submission/Application Fee Form (PDF fillable/saveable (923 KB)) [2016-04-01]
(DOC Version - 107 K)
- How to Pay Fees to Health Products and Food Branch (HPFB) [2016-04-01]
- Advance Payment Details for Drug Submissions and Master Files (PDF fillable/saveable (1.7 MB)) [2016-04-01]
- Details for Payment of a Drug Submission Invoice (PDF fillable/saveable (594 KB)) [2016-04-01]
- Form IV: Patent List - Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable (466 KB))[2014-09-12]
(DOC Version - 64 K) - Form V: Declaration re: Patent List Patented Medicines (Notice of Compliance) Regulations (PDF fillable/saveable (406 KB)) [2013-11-22]
(DOC Version - 43 K) - Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation (PDF fillable/saveable (657 KB)) [2013-12-12]
(DOC Version - 222 K)
- Labelling Standard and Category IV Submission Check List (PDF fillable/saveable (406 KB)) [2013-11-20]
(DOC Version - 43 K) - Mock-Up Labels and Packages Certification Form (PDF fillable/saveable (129 KB)) [2015-08-19]
- Non-prescription drug monograph attestation form (PDF fillable/saveable (648 KB)) [2016-01-15]
- Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form - Notice [2016-02-19]
- Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form (PDF fillable/saveable (431 KB)) [2016-02-19]
- Product Monograph Certification Form (PDF fillable/saveable (404 KB)) [2013-11-07]
(DOC Version - 43 K) - Product Monograph Translation Certification Form (PDF fillable/saveable (403 KB)) [2015-07-13]
(DOC Version - 43 K) - 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 K) - Notice - Updated Screening Criteria for Generic Drug Submissions [2013-01-09]
