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Ministry Status: Activation Status

Drug Submissions

Guideline and Template Downloads

Guidelines Format
Ontario Guidelines for Drug Submission and Evaluation - September 2016 PDF

Addendum #1 to Ontario Guidelines for Drug Submission and Evaluation

Part III-A.8. – Generic Line Extension Product

Part III-A.9. – Transitioning Unlisted Products from Exception Access Program (EAP) to the Formulary

Part III-B.2.o – Streamline Submissions for all Generic Products with a Declaration of Equivalence (DOE) from Health Canada

Part III-B.2.p – Non-Systemic Effect Drug Product

Part III-B.6. – Transition of Generic Products from Exceptional Access Program (EAP) to the Formulary

PDF
Templates, Checklists and Worksheets Format
(Part VI Ontario Guidelines for Drug Submission and Evaluation)
Submissions under the Ontario Drug Benefit Act – September 2016
Clinical Data Checklist PDF | MS Word
ODB Financial Impact Analysis - Assumptions and Estimates Excel
ODB Financial Impact Analysis - Summary PDF | MS Word
Pharmacoeconomic Analysis - Worksheet PDF | MS Word
Pharmacoeconomic Analysis - Summary PDF | MS Word
Submission Summary - Single Source Products Submitted Under ODBA MS Word
Template Letter of Ability to Supply - Updated September 16, 2016 PDF | MS Word
Template Letter Certification of Providing No Rebate PDF | MS Word
Template Letter of Consent PDF | MS Word
Template Letter of Consent for Rapid Review PDF | MS Word
Template Letter Certification Confirming Product is not a Private Label Product PDF | MS Word
Template Letter of Confirmation of Same Formulation for Clinical and Commercial Lot PDF | MS Word
Submissions under the Drug Interchangeability and Dispensing Act – September 2016
Aqueous Solution Checklist PDF | MS Word
Bioequivalence Data Checklist PDF | Word
Pharmacokinetic - Statistical Worksheet PDF | MS Word
Submission Summary - DIDFA MS Word
Template Letter Current Patent Status PDF | MS Word
Template Letter of Ability to Supply - September 16, 2016 PDF | MS Word
Template Letter of Consent PDF | MS Word
Template Letter of Product Confirmation PDF | MS Word
Template Letter Certification of Providing No Rebate PDF | MS Word
Template Letter Certification Confirming Product is not a Private Label Product PDF | MS Word
New Submission Deadline Dates Format
New Submission Deadline Dates for Multiple Source Products 2016-2017 Web Page

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