Drug Submissions

Ontario Guidelines for Drug Submission and Evaluation

A drug product will be considered for listing and interchangeability designation in the Formulary where a pharmaceutical manufacturer has made a submission to the Ontario Ministry of Health. The submission must comply with the requirements specified in O. Reg. 201/96 under the Ontario Drug Benefit Act and Regulation 935 under the Drug Interchangeability and Dispensing Fee Act.

The purpose of the interpretive guidelines is to assist pharmaceutical manufacturers in making their drug submissions. The guidelines include various template letters, checklists and worksheets for manufacturers to use in preparing their submissions to the ministry.

PDF copies of the Ontario Guidelines for Drug Submission and Evaluation are available for download at Drug Submissions.

Pharmaceutical manufacturers should refer to this website for any future updates to the interpretive guidelines.

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See Also:

• Drug Submission Policy Directive
• Guideline and Template Downloads
• Drug Submission Status
• New Submission Deadline Dates for Multiple Source Products
• Ontario Guidelines for Economic Analysis of Pharmaceutical Products

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