O. Reg. 495/00: GENERAL

 

ontario regulation 495/00

made under the

ONTARIO drug benefit act

Made: August 23, 2000
Filed: August 28, 2000

Amending O. Reg. 201/96

(General)

1. Section 11 of Ontario Regulation 201/96 is amended by striking out “clause 12 (1) (e)” wherever it occurs and substituting in each case “clause 12 (1) (d)”.

2. (1) Clauses 12 (1) (a) and (b) of the Regulation are revoked and the following substituted:

(a) evidence that Health Canada has approved the product for sale in Canada, a copy of the product’s drug notification form issued by Health Canada and, subject to subsection (2), a copy of the product monograph approved by Health Canada;

(b) a letter authorizing the Minister to  gain access to all information with respect to the product in the possession of Health Canada, the Patented Medicine Prices Review Board established under section 91 of the Patent Act (Canada) or of the government of any province or territory in Canada and authorizing the Minister to disclose any information with respect to the product in the possession of the Ministry to Health Canada, the Patented Medicine Prices Review Board or to the government of a province or territory in Canada;

(2) Clauses 12 (1) (d) and (e) of the Regulation are revoked and the following substituted:

(d) the proposed drug benefit price of the product;

(e) evidence that the manufacturer is able to supply the product at the proposed drug benefit price in a quantity sufficient to meet the anticipated demand for the product;

(3) Subsection 12 (2) of the Regulation is amended by striking out “If the Health Protection Branch of Health Canada” at the beginning and substituting “If Health Canada”.

(4) Section 12 of the Regulation is amended by adding the following subsection:

(3.1) A manufacturer may satisfy the condition set out in clause (1) (h) for a format of a drug product by submitting the clinical evidence referred to in clause (1) (h) for another format of the drug product, if the evidence is sufficient for the purposes of evaluating the therapeutic effectiveness or efficacy and safety of both the formats of the product.

(5) Subsection 12 (4) of the Regulation is amended by striking out “the condition set out in clause (1) (h) for a strength of a drug product” and substituting “the condition set out in clause (1) (h) for a drug product”.

3. Section 12.0.1 of the Regulation is amended by adding the following subsection:

(2) Subsection (1) does not apply to a drug product that is designated as an interchangeable product under the Drug Interchangeability and Dispensing Fee Act.