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 and Long-Term Care. 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. Submissions must be properly prepared and formatted as indicated in Parts I and II of the interpretive guidelines.

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.

A .pdf copy of the Ontario Guidelines for Drug Submission and Evaluation is available for download or copies may also be purchased from Publications Ontario at 1-800-668-9938 or 416-326-5300.

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

The Ministry is currently in the process of updating the Ontario Guidelines for Drug Submission and Evaluation to reflect and consolidate the regulatory and policy changes that have been implemented and communicated since September 2000. Note that the current Guidelines, prior to their amendment, may contain some inconsistencies with current legislation and regulations. Consult with the applicable legislation and regulations for the statement of the current law. In the event of any inconsistency between the Guidelines and the regulations and legislation, the regulations and legislation prevail.

See Also :

• Improving Patient Access to Drugs: Rapid Review Process
• Single Monthly Formulary Process
• Off-Formulary Interchangeability
• Ontario Guidelines for Economic Analysis of Pharmaceutical Products
• Submission Guidelines for Oncology Drugs
• Inter-Provincial Joint Oncology Drug Review Process
• Submission Guidelines for Diabetic Testing Agents
• Submission Guidelines for Nutrition Products
• Guideline and Template Downloads