O. Reg. 496/00: GENERAL

 

ontario regulation 496/00

made under the

drug interchangeability and dispensing fee act

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

Amending Reg. 935 of R.R.O. 1990

(General)

1. (1) Clause 6 (1) (a) of Regulation 935 of the Revised Regulations of Ontario, 1990 is 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;

(2) Clause 6 (1) (b) of the Regulation is amended by striking out “the Health Protection Branch of Health Canada” wherever it occurs and substituting in each case “Health Canada”

(3) Clause 6 (1) (c) of the Regulation is revoked and the following substituted:

(c) documentation disclosing the product’s master formulation;

(4) Clauses 6 (1) (d), (d.1) 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;

(5) Clause 6 (1) (g) of the Regulation is revoked.

(6) Clause 6 (1) (i) of the Regulation is revoked.

(7) Subsection 6 (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”.

(8) Subsection 6 (3) of the Regulation is amended by striking out “Clauses (1) (g) and (h)” at the beginning and substituting “Clauses (1) (c) and (h)”.

(9) Subsection 6 (5) of the Regulation is amended by striking out the portion before paragraph 1 and substituting the following:

(5) Clause (1) (h) does not apply with respect to a drug product that is pharmaceutically equivalent to the original product, demonstrates the same physicochemical properties of the original product, is the same dosage form, packaging format and volume as the original product and is one of the following:

. . . . .

(10) Subsections 6 (6) and (7) of the Regulation are revoked and the following substituted:

(6) Clause (1) (c) does not apply with respect to a product that has been designated as bioequivalent to the original product by Health Canada unless the product is described in subsection (5).

(7) Clause (1) (h) does not apply with respect to a product that has been designated as bioequivalent to the original product by Health Canada if it is required to provide bioavailability studies to Health Canada under Part A or B of the guideline available from Health Canada and entitled “Conduct and Analysis of Bioavailability and Bioequivalence Studies”.

2. Section 7 of the Regulation is amended by striking out “clause 6 (1) (d.1)” wherever it occurs and substituting in each case “clause 6 (1) (d)”.