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Ministry Status: Recovery


The ministry is resuming regular operations and supporting health sector stabilization.

Drug Submissions

Guidelines

Ontario Guidelines for Drug Submission and Evaluation
Ontario Guidelines for Single Source Drug Products
Ontario Guidelines for Biosimilar Products
Ontario Guidelines for Multiple Source Drug Products
Ontario Guidelines for Diabetic Testing Agents
Ontario Guidelines for Nutrition Products
Ontario Guidelines for Flash Glucose Monitoring
Ontario Guidelines for Valved Holding Chambers
Ontario Guidelines for Transitioning Unlisted Single Source Drug Products from the Exceptional Access Program (EAP) to the Ontario Drug Benefit Formulary/ Comparative Drug Index
Ontario Guidelines for Transitioning Generic Drug Products from the Exceptional Access Program (EAP) to the Ontario Drug Benefit Formulary/ Comparative Drug Index
Ontario Guidelines for Notification of Change to Brand Drug Products
Ontario Guidelines for Notification of Change to Generic Drug Products

Templates, Checklists and Worksheets

Templates, Checklists and Worksheets for Submissions under the Ontario Drug Benefit Act (ODBA)
Clinical Data Checklist
OPDP Financial Impact Analysis - Summary
Pharmacoeconomic Analysis - Worksheet
Pharmacoeconomic Analysis - Summary
Template Letter of Ability to Supply
Template Letter Certification of Providing No Rebate
Template Letter of Consent
Template Letter of Consent for Rapid Review
Nutrition Product Summary
Nutrition Product Work Sheet
Templates, Checklists and Worksheets for Submissions under the Drug Interchangeability and Dispensing Act (DIDFA)
Aqueous Solution Checklist
Bioequivalence Data Checklist
Pharmacokinetic - Statistical Worksheet
Submission Summary - DIDFA
Template Letter Current Patent Status
Template Letter of Ability to Supply
Template Letter of Consent
Template Letter of Product Confirmation
Template Letter Certification of Providing No Rebate
New Submission Deadline Dates for Multiple Source Products
New Submission Deadline Dates

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See Also:

For More Information

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In Toronto, (416) 314–5518
TTY 1–800–387–5559.
In Toronto, TTY (416)327–4282
Hours of operation: Monday to Friday, 8:30 a.m. – 5:00 p.m.

 
 
 
 
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