The Ontario Ministry of Health and Long-Term Care recently
updated the Ontario Guidelines for Drug Submission and Evaluation
("Guidelines"). These Guidelines govern
drug submissions for inclusion on the Ontario Drug Benefit
Formulary or for listing as an interchangeable drug.
Despite various amendments to the regulations under the
Ontario Drug Benefit Act and the Drug
Interchangeability and Dispensing Fee Act
("Regulations"), this is the first time
the Guidelines have been updated since 2000.
The Guidelines provide practical information and guidance to
manufacturers making drug submissions to the province of Ontario in
order to have drug products listed on the Ontario Drug Benefit
Formulary or as interchangeable products under the Drug
Interchangeability and Dispensing Fee Act.
This update to the Guidelines consolidates changes made to the
Regulations as well as related changes to submission policy. The
Guidelines do not address recent proposed changes to the
Regulations intended to streamline generic interchangeability
The Guidelines can be found at the link below and include an
executive summary of these changes.
Highlights of changes to the Regulations since 2000 include:
exemption from the requirement to
provide in-vivo bioequivalence studies for dermatological
glucocorticoids and certain aqueous solutions;
limiting the price for most
interchangeable drug products to 25% of the price of the original
a rapid review process for
single-source products that can take place prior to receiving a
Notice of Compliance from Health Canada if certain criteria are
a requirement that manufacturers
confirm that no rebates were provided to listed persons and that
the product is not a private label product; and
allowing the Executive Officer to
consider making an interchangeability designation for products
containing the same amounts of the same or similar active
ingredients in the same or similar dosage form.
Highlights of changes to submission policy since 2000
streamlined processes in listing
single-source products that have been reviewed by the Common Drug
Review or the pan-Canadian Oncology Drug Review, and
multiple-source products that have received a Declaration of
Equivalence from Health Canada;
limitations that have been imposed on
the consideration of non-prescription medications and natural
a requirement that manufacturers
advise that there are no outstanding patent issues; and
a challenge mechanism for
non-streamlined multi-source product submissions.
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