Drug Submissions
Drug Submission Policy Directive
The Ontario Guidelines for Drug Submission and Evaluation (the Guidelines) were developed to provide manufacturers with practical information and guidance to facilitate the submission of information to the Ministry. From time to time and as circumstances warrant, the Ministry may amend, clarify or institute new policies, practices or procedures relating to drug submissions and the review process. The Ministry will notify manufacturers of such clarifications or changes by posting policy directives on the Ministry’s website and by issuing notices from the Ontario Public Drug Programs.
Should there be any inconsistencies or conflicts between the Guidelines and a policy directive, the more recent document will prevail.
| Title | Format |
|---|---|
| Policy Directive - Drug Submission: Changes to the Template Letters - November 30, 2022 |
English | French |
| Policy Directive - Drug Submission: Changes to the Template Letter of Consent - August 31, 2022 |
English | French |
| Policy Directive – Updates to the Ontario Guidelines for Drug Submission and Evaluation - January 11, 2022 | English | French |
| Policy Directive – Updates to the Ontario Guidelines for Drug Submission and Evaluation - March 23, 2020 | English | French |
| Policy Directive – Drug Submission: Addendum # 5 to the Ontario Guidelines for Drug Submission and Evaluation – effective January 1, 2020 | English | French |
| Policy Directive- New Submission Deadline Time for Multiple Source Products – December 19, 2019 | English | French |
| Policy Directive - Drug Submission - Updates to the Ontario Guidelines for Drug Submission and Evaluation – December 23, 2019 | English | French |
| Policy Directive - Biosimilar Products – October 1, 2019 | English | French |
| Policy Directive - Flash Glucose Monitoring Guidelines – July 24, 2019 | English | French |
| Policy Directive - Update to the Ontario Guidelines for Drug Submission and Evaluation: Removal of Hard Copy Requirement - July 1, 2019 | English | French |
| Policy Directive – Valved Holding Chambers (VHCs) Guidelines – January 1, 2018 | English | French |
| Policy Directive – Addendum #1 to Ontario Guidelines for Drug Submission and Evaluation – October 1, 2016 | |
| Policy Directive – Notice of Change in Product Monograph (PM) matching Innovator PM – June 8, 2016 – Archived | |
| Policy Directive - Submission requirement for the number of hard copies for Multiple Source Submissions and for Single Source Submissions – July 30, 2015 – Archived | |
| Drug Submission - Information Bulletin –March 22, 2016 | English | French |
| Policy Directive – Notice of compliance for cross-reference products – February 14, 2014 – Archived |
See Also:
Public Information
