Recent amendments have been made to the Ontario Regulation 201/96 under the Ontario Drug Benefit Act (‘ODBA Regulation’) and to Regulation 935 under the Drug Interchangeability and Dispensing Fee Act (‘DIDFA Regulation’). The amendments have been approved by the Ontario Government and come into force on October 1, 2016.
A notice was posted on the ministry’s website on June 1, 2016, that provided stakeholders with information on the proposed amendments to the ODBA Regulation and DIDFA Regulation. Stakeholders were given a 45-day period to comment on the proposed regulatory amendments.
The amendments to the ODBA Regulation and DIDFA Regulation establish the following:
- Enable more appropriate access to certain drugs through Formulary listing, which are currently only available under the Exceptional Access Program;
- Allow for the remaining generic products with a Declaration of Equivalence designation from Health Canada to be reviewed under the faster, streamlined drug submission process; and
- Allow for new strengths of a generic product that do not have a comparable reference product to be considered for listing based on evidence other than product-specific clinical studies.
For the authoritative text of the consolidated DIDFA Regulation, please visit the e-Laws website.
For the authoritative text of the consolidated ODBA Regulation, please visit the e-Laws website.
The Ontario Public Drug Programs (OPDP) is publishing an addendum to the Ontario Guidelines for Drug Submission and Evaluation (Guidelines) to assist the manufacturers in making drug submissions to the OPDP resulting from the recent regulatory amendments as described above. The addendum will be posted by October 6, 2016. For this information, please visit the ministry’s website at: Drug Submissions.
Any questions regarding the changes to the ODBA Regulation and DIDFA Regulation can be directed to:
Executive Officer, Ontario Public Drug Programs
Ministry of Health and Long-Term Care
80 Grosvenor Street, 9th Floor
Hepburn Block, Queen’s Park
Toronto, ON M7A 1R3