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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: Information regarding interim measures to respond to scenarios that may arise due to COVID-19 - March 23, 2020 English | French
PDF
Policy Directive – Drug Submission: Addendum # 5 to the Ontario Guidelines for Drug Submission and Evaluation – effective January 1, 2020 English | French
PDF
Policy Directive- New Submission Deadline Time for Multiple Source Products – December 19, 2019 English | French
PDF
Policy Directive - Drug Submission -  Updates to the Ontario Guidelines for Drug Submission and Evaluation – December 23, 2019 English | French
PDF
Policy Directive - Biosimilar Products – October 1, 2019 English | French
PDF
Policy Directive - Flash Glucose Monitoring Guidelines – July 24, 2019 English | French
PDF
Policy Directive - Update to the Ontario Guidelines for Drug Submission and Evaluation: Removal of Hard Copy Requirement - July 1, 2019 English | French
PDF
Policy Directive – Valved Holding Chambers (VHCs) Guidelines – January 1, 2018 English | French
PDF
Policy Directive – Addendum #1 to Ontario Guidelines for Drug Submission and Evaluation – October 1, 2016 PDF
Policy Directive – Notice of Change in Product Monograph (PM) matching Innovator PM – June 8, 2016 – Archived PDF
Policy Directive - Submission requirement for the number of hard copies for Multiple Source Submissions and for Single Source Submissions – July 30, 2015 – Archived PDF
Drug Submission - Information Bulletin –March 22, 2016 English | French
PDF
Policy Directive – Notice of compliance for cross-reference products – February 14, 2014 – Archived PDF

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