Overview

Drugs funded through Ontario Public Drug Programs are either listed in the Formulary or they are considered for individual review through the Exceptional Access program.

The Formulary:

  • identifies over 5,000 drug products designated as benefits under the program as well as drug products that are considered to be interchangeable
  • serves as a reimbursement guide for physicians and pharmacists. Drug products listed in the Formulary are designated as General Benefit or Limited Use Drugs

For drug products to be eligible for listing in the Formulary, a drug manufacturer must provide a complete submission in accordance with the prescribed conditions set out in the following regulations:

Or

Interpretive guidelines have been published by the ministry to assist manufacturers in making their submissions.

Drug submissions are then considered for ministry funding through a defined review and funding process. Find more information on how drugs are approved.

Drug submission guidelines and templates

Drug products are considered for listing or interchangeability designation in the Ontario Drug Benefit Formulary when a drug 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 (ODBA) or Regulation 935 under the Drug Interchangeability and Dispensing Fee Act (DIDFA).

The interpretive guidelines aim to assist drug manufacturers in making their drug submissions. Drug manufacturers can use the applicable guidelines, template letters, checklists, and worksheets to prepare their submissions to the ministry.

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

Guidelines

Templates, checklists and worksheets

For submissions made under the Ontario Drug Benefit Act (ODBA)

For submissions made under the Drug Interchangeability and Dispensing Fee Act (DIDFA)

New drug submission deadline dates for multiple source products

The following dates apply to new Formulary and Off-Formulary Interchangeable (OFI) multiple source drug product submissions.

Note: The ministry reserves the right to change the schedule of the submission dates. Changes will be posted on this website approximately 30 days before any new date becomes effective. The onus will be on the manufacturers to check the Health Programs and Delivery Division Notice and this website on a regular basis.

New Submission Deadline Dates for Multiple Source Products 2024
MonthSubmission Date Before 3:00 p.m.
JanuaryJanuary 3
FebruaryFebruary 7
MarchMarch 6
AprilApril 3
MayMay 1
JuneJune 5
JulyJuly 3
AugustAugust 7
SeptemberSeptember 4
OctoberOctober 2
NovemberNovember 5
DecemberDecember 4

*Applies to Formulary and Off-Formulary Interchangeable (OFI) submissions.

Note: The Ministry reserves the right to change the schedules of the submission date. Changes will be posted on this website approximately 30 days before any new date becomes effective. The onus will be on the manufacturers to check the Health Programs and Delivery Division Notice and this website on a regular basis.

New Submission Deadline Dates for Multiple Source Products 2023
MonthSubmission Date Before 3:00 p.m.
JanuaryJanuary 4
FebruaryFebruary 1
MarchMarch 1
AprilApril 5
MayMay 3
JuneJune 7
JulyJuly 5
AugustAugust 2
SeptemberSeptember 6
OctoberOctober 4
NovemberNovember 1
DecemberDecember 6

Drug submission status

The ministry publicly posts the status of manufacturers' drug submissions to allow industry stakeholders and the public to track the status of drug submissions through the various stages of the review cycle.

The ministry posts drug submission status for single-source (generally brand name) submissions, and complete streamlined multiple-source (generally generic) submissions. Posting of status for other submission types (for example, non-streamlined multiple-source submissions) may be considered in the future depending on stakeholder interest and ministry resources.

The posting of drug submission status was first implemented in June 2008, which included single-source drug submissions undergoing first review received on June 1, 2008 and streamlined multiple-source drug submissions for Formulary listing received by the June 4, 2008 deadline.

Beginning in February 2009, postings of complete streamlined multiple-source submissions for Off-Formulary Interchangeability considerations became available. At the same time, submissions for diabetic test strips were added to the single-source submission postings.

Since July 2011, the postings have included status of single-source drug submissions undergoing subsequent reviews.

The status of single-source submissions is updated on a bi-weekly basis. The posting for streamlined multiple-source submissions is updated monthly. Please find the submission status updates below:

Status of single-source submissions

New single-source drug submissions under review

 

Review Status Legend

Submission completed & under review 
(CDA-AMC/CED/OSCCD) — Manufacturer met all submission requirements and an evaluation of the submission is underway.

Review completed (CDA-AMC/CED/OSCCD) — A review has been completed.

Negotiation — The drug is “under negotiation”. Refer to the pCPA website for negotiation status.

Negotiation concluded — the negotiation has concluded. Refer to the pCPA website for negotiation status.

  • CDA-AMC: Canada’s Drug Agency
  • CED: Committee to Evaluate Drugs
  • OSCCD: Ontario Steering Committee for Cancer Drugs

To find out if a drug product has already been funded, please check medication coverage through the ODB program.

To find out if an IV cancer drug product has already been funded, please check the Ontario Health — Cancer Care Ontario Formulary

Find out if your medication is already covered through the Ontario Drug Benefit program.

Complete streamlined multiple-source submissions for future Formulary listing

The Ministry of Health (the “ministry”) has received complete submissions for the following streamlined multiple-source (usually, generic) drug products for listing on the Ontario Drug Benefit Formulary.
Subject to confirmation of Drug Identification Numbers (DIN) and prices by the manufacturers, as well as review and approval by the Executive Officer, these products may be listed as benefits in a future Formulary update. Final listing status will be communicated when the Formulary update is published on the ministry website and via the Health Programs Delivery Division notices.

2024

2023

2022

2021

2020

Historical archive of multiple-source submissions for future Formulary listing published prior to 2020

Complete streamlined multiple-source submissions for future Formulary listing — OFI

Find complete submissions for multiple-source drug products for Off-Formulary Interchangeability (OFI) designation.

The ministry has received complete submissions for the following streamlined multiple-source drug products for OFI designation. Subject to confirmation of Drug Identification Numbers (DIN) and prices by the manufacturers, as well as review and approval by the Executive Officer, these products may be designated as OFI drugs in a future Formulary update. Final OFI designation status will be communicated when the Formulary update is published on the ministry website and via the Health Programs and Delivery Division (HPDD) Notice.

2024

2023

2022

2021

2020

Historical archive of multiple-source submissions for future Formulary listing published prior to 2020

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.

Drug Submission Policy Directive
DateTitle
March 7, 2024

Drug Submission: Policy Directive

November 30, 2022Drug Submission: Changes to the Template Letters
August 31, 2022Drug Submission: Changes to the Template Letter of Consent
January 11, 2022Updates to the Ontario Guidelines for Drug Submission and Evaluation
March 23, 2020Updates to the Ontario Guidelines for Drug Submission and Evaluation
 January 1, 2020Drug Submission: Addendum #5 to the Ontario Guidelines for Drug Submission and Evaluation
December 23, 2019Drug Submission: Updates to the Ontario Guidelines for Drug Submission and Evaluation
December 19, 2019New Submission Deadline Time for Multiple Source Products
October 1, 2019Biosimilar Products
July 24, 2019Flash Glucose Monitoring Guidelines
July 1, 2019Update to the Ontario Guidelines for Drug Submission and Evaluation: Removal of Hard Copy Requirement
January 1, 2018Valved Holding Chambers (VHCs) Guidelines
October 1, 2016Addendum #1 to Ontario Guidelines for Drug Submission and Evaluation
June 8, 2016Notice of Change in Product Monograph (PM) matching Innovator PM - Archived
July 30, 2015Submission requirement for the number of hard copies for Multiple Source Submissions and for Single Source Submissions - Archived
March 22, 2016Drug Submission - Information Bulletin - Archived
February 14, 2014Notice of compliance for cross-reference products - Archived

Contact us

Inquiries regarding drug submissions should be directed to:

5700 Yonge Street, 3rd Floor
Toronto, Ontario M2M 4K5
Tel: 416-327-8099
Fax: 416-327-8123
Email: PublicDrugPrgrms.moh@ontario.ca