O. Reg. 354/08: GENERAL
filed October 16, 2008 under Drug Interchangeability and Dispensing Fee Act, R.S.O. 1990, c. P.23Skip to content
ontario regulation 354/08
made under the
drug interchangeability and dispensing fee act
Made: October 15, 2008
Filed: October 16, 2008
Published on e-Laws: October 20, 2008
Printed in The Ontario Gazette: November 1, 2008
Amending Reg. 935 of R.R.O. 1990
1. Section 7 of Regulation 935 of the Revised Regulations of Ontario, 1990 is amended by adding the following subsection:
(6) For greater certainty, upon the application of the manufacturer, the executive officer may re-designate a drug product as a benefit under the Ontario Drug Benefit Act that was designated on the Formulary before December 31, 2007, and whose designation was removed by either of the amendments to the Formulary known as Update 8 to Edition 40, effective January 15, 2008, or Update 8A to Edition 40, effective January 17, 2008, subject to the following:
1. The submission requirements set out in subsection 6 (1) shall be deemed to have been met with respect to the product.
2. The conditions for continued listing set out in section 8 must be met with respect to the product.
3. The criteria established by the executive officer under section 12.2 of Ontario Regulation 201/96 under the Ontario Drug Benefit Act must be met with respect to the product.
2. (1) Paragraph 4 of subsection 8 (1) of the Regulation is amended by striking out “paragraphs 5 and 5.1” and substituting “paragraphs 5, 5.1 and 5.2”.
(2) Paragraph 5 of subsection 8 (1) of the Regulation is amended by adding at the end “This paragraph applies only with respect to the version of the Formulary known as Edition No. 39, published on October 23, 2006”.
(3) Subsection 8 (1) of the Regulation is amended by adding the following paragraph:
5.2 Paragraph 4 does not apply with respect to a product that has been designated as interchangeable with an original product where the manufacturer of the interchangeable product has submitted evidence satisfactory to the executive officer of substantial raw material cost increases, and the executive officer is satisfied that the criteria established under section 12.2 of Ontario Regulation 201/96 (General) made under the Ontario Drug Benefit Act have been met establishing that it is in the public interest that the interchangeable product be listed at a higher drug benefit price, but in no case may the interchangeable product be priced higher than the original product.
(4) Subsection 8 (3) of the Regulation is amended by striking out “paragraph 5 or 5.1” and substituting “paragraph 5, 5.1 or 5.2”.
3. This Regulation comes into force on the day it is filed.