Motion No. 1
That Bill C-393 be amended by restoring Clause 2 as follows:
“2. Section 21.02 of the Act is replaced by the following:
21.02 The definitions in this section apply in sections 21.01 to 21.16.
“authorization” means an authorization granted under subsection 21.04(1).
“pharmaceutical product” means any drug, as defined in section 2 of the Food and Drugs Act, and includes monitoring products and products used in conjunction with a pharmaceutical product.”
Motion No. 2
That Bill C-393 be amended by restoring Clause 4 as follows:
“4. (1) Subsection 21.04(1) of the Act is replaced by the following:
21.04 (1) Subject to subsections (3) and (4), the Commissioner shall, on the application of any person and on the payment of the prescribed fee, authorize the person to
(a) manufacture the pharmaceutical product or products named in the application;
(b) make, construct and use any patented invention solely for the purpose of manufacturing the product or products; and
(c) sell the product or products for export to a country that is listed in the Schedule.
(1.1) In addition to what is authorized under subsection (1), an authorization under that subsection authorizes the person to
(a) manufacture any active ingredient used in the manufacture of a finished product; and
(b) make, construct and use any patented invention solely for the purpose of manufacturing any active pharmaceutical ingredient used in the manufacture of a finished product.
(1.2) If a country is removed from the Schedule an authorization continues to apply with respect to that country for 30 days as though that country had not been removed from the Schedule.
(2) Subsection 21.04(2) of the Act is amended by adding “and” at the end of paragraph (a) and by repealing paragraphs (b) to (f).
(3) Subsection 21.04(3) of the Act is replaced by the following:
(3) The Commissioner shall grant an authorization only if the applicant has complied with the prescribed requirements.”