Forms – Applications and submissions – Drug products
- Mock-Up Labels and Packages Certification Form for Non-prescription Drugs and Contact Lens Disinfectants [2017-05-31]
- 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 KB) [2016-01-15]
(DOC Version - 40 KB) - Changes in Manufacturer/Sponsor Name and/or Product Name: Administrative Changes - Certification Form for Human, Veterinary or Disinfectant Drugs (PDF fillable/saveable - 428 KB) [2017-02-03]
(DOC Version - 45 KB) - Clinical Trial Site Information Form (PDF fillable/saveable - 488 KB) [2013-12-13]
(DOC Version - 132 KB) - 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) [2017-03-24]
Master Files for Human Drugs:
- Master File (MF) Application Fee Form for Human Drugs (PDF fillable/saveable - 870 KB) [2017-05-01]
(DOC Version - 67 KB) - How to Pay Fees to Health Products and Food Branch (HPFB) [2016-10-19]
- Advance Payment Details for Drug Submissions and Master Files (PDF fillable/saveable - 924 KB) [2017-02-01]
- Drug Master File (DMF) Application Form (PDF fillable/saveable - 490 KB) [2012-03-13]
(DOC Version - 38 KB)
Drug Submission - Applications for Human and Disinfectant Drugs:
- Drug Submission - Application Fee Form for Human and Disinfectant Drugs (PDF fillable/saveable - 500 KB) [2017-03-03]
(DOC Version - 113 KB) - How to Pay Fees to Health Products and Food Branch (HPFB) [2016-10-19]
- Advance Payment Details for Drug Submissions and Master Files (PDF fillable/saveable - 924 KB) [2017-02-01]
- Details for Payment of a Drug Submission Invoice (PDF fillable/saveable - 618 KB) [2016-10-19]
- 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 - 406 KB)[2013-11-22]
(DOC Version - 43 KB) - 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 KB) - Labelling Standard and Category IV Submission Check List (PDF fillable/saveable - 406 KB) [2013-11-20]
(DOC Version - 43 KB) - 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]
- Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form - Notice [2016-11-03]
- Post-Notice of Compliance (NOC) Changes: Notices of Change (Level III) Form (PDF fillable/saveable - 431 KB) [2016-11-03]
- 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) - Notice - Updated Screening Criteria for Generic Drug Submissions [2013-01-09]
- Sponsor Attestation Checklist for Abbreviated New Drug Submissions (ANDS) [2017-03-29]
(DOC Version - 43 KB)
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