Introduction

Paragraph 1 of section 12.1(1) of Ontario Regulation 201/96 (the “ODBA Regulation”) under the Ontario Drug Benefit Act (ODBA) requires manufacturers of listed drug products designated on the Formulary to notify the ministry of changes made to the drug products. This requirement also applies by policy to brand drug products not designated on the Formulary but otherwise funded under Ontario Public Drug Programs (e.g. products funded under the Exceptional Access Program).

The objective of this document is to provide guidance on the submission requirements for a notification of change to a brand drug product described above.

The ministry must be notified of any changes in ownership, Drug Identification Number (DIN), company name, drug product name, formulation or significant changes to the Product Monograph. Significant changes include any changes to indications or substantive changes to contraindications, adverse effects or warning/precautions.

Submission requirements

All notification of change submissions must include a cover letter with the following:

  • A description of the change(s) and a brief rationale for the change(s);
  • The drug product(s) including the DIN(s) affected by the change(s);
  • Confirmation that the master formulation has not changed, and confirmation that the bioavailability has not been affected*; and
  • Confirmation that Health Canada has approved the change(s).

The cover letter must contain the appropriate manufacturer’s letterhead, dated and signed by a senior company official.

If the Product Monograph has been updated, the manufacturer is required to provide the updated Product Monograph (annotated/ tracked and non-annotated) with the most recent date of revision and control number. (Note: Confirmation that the master formulation has not changed, and confirmation that the bioavailability has not been affected is not a requirement for changes to the Product Monograph).

The ministry will review the changes and determine if the notification is complete or incomplete based on the above requirements. The ministry will not issue a confirmation letter for complete submissions.

Manufacturers should monitor for update notices from the Health Programs and Delivery Division, as well as updates to the Formulary which can be found on the ministry’s website.

For incomplete submissions, manufacturers will be asked to respond to the ministry with the information required to complete the submission. In such cases, an incomplete letter will be issued.

The ministry also reserves the right to ask manufacturers for additional information regarding any changes made to the drug product.

*Note: In all cases, if bioavailability has been affected, a new comparative bioavailability study (or a justification for not providing a study), or the scientific data provided to Health Canada is required.

Filing of drug submissions

The Health Programs and Delivery Division accepts e-mail submissions.

All submissions and any additional related information must be sent to:

Senior Manager
Drug Benefits Management Unit
Drug Programs Policy and Strategy Branch
Health Programs and Delivery Division
Ministry of Health

Please email the submissions to DrugSubmissions.MOH@ontario.ca.