The Ontario Public Drug Programs (OPDP) is publishing an addendum (Addendum #1) to the Ontario Guidelines for Drug Submission and Evaluation (Guidelines) to assist the manufacturers in making drug submissions to the OPDP. Addendum #1 contains information about the regulatory amendments that were recently approved by the Ontario government and came into force on October 1, 2016.

Amendments were made to the following regulations:

• Regulation 935 under the Drug Interchangeability and Dispensing Fee Act (DIDFA):
  • Subsection 1 (1) – amended definition of “generic line extension drug product”
  • Section 6 – subsection (3.1) added
  • Subsections 6 (5.1), (6), (7), (7.1) and (7.2) – have been revoked, (6) and (7) substituted
• Ontario Regulation 201/96 under the Ontario Drug Benefit Act (ODBA):
  • Section 12 – amended by subsections (2.1) and (5.1)

Addendum #1 will be posted on the ministry’s website by October 6, 2016, and will be effective and strictly enforced as of October 6, 2016. Any submission made to OPDP on or after October 6, 2016 must comply with the applicable provisions in Addendum #1.

Addendum #1 will be available through the following link by October 6, 2016.