Drugs and Devices

Drug Submissions

Drugs funded through Ontario Public Drug Programs are either listed in the Formulary or they are approved through the Exceptional Access program.

The Formulary identifies over 3,200 drug products designated as benefits under the program, as well as drug products that are considered to be interchangeable, and 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:

• O. Reg. 201/96 under the Ontario Drug Benefit Act
  ODBA - Amendments to O. Reg. 201/96:
  1. O. Reg. 320/07
  2. O. Reg. 459/06
  3. O. Reg. 559/06
• Regulation 935 under the Drug Interchangeability and Dispensing Fee Act
  Amendments to Reg. 935:
  1. O. Reg. 321/07
  2. O. Reg. 458/06
  3. O. Reg. 558/06

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

Each complete submission undergoes a thorough review by the Committee to Evaluate Drugs (CED). Following its review, the CED makes recommendations to the Executive Officer as to whether a drug product should be listed as a Formulary benefit or designated as an interchangeable drug product. As well, CED makes recommendations as to drug products that should be available through the Exceptional Access program. Conditional listing or partnership proposals contained in a drug submission are reviewed by the Ministry, taking into consideration the CED's recommendations. Find out more in the section on how drugs are approved.

This Drug Submission section provides information in the following areas:

• Ontario Guidelines for Drug Submission and Evaluation
• Drug Submission Policy Directive
• Drug Submission Status
• Ontario Guidelines for Economic Analysis of Pharmaceutical Products
• Submission Guidelines for Long-Acting Oxycodone Products [PDF]
• New Submission Deadline Dates for Multiple Source Products
• Guideline and Template Downloads