Food and Drug Regulations (C.R.C., c. 870)

C.07.001. The definitions in this section apply in this Division.

“Commissioner of Patents”

“Commissioner of Patents” means the Commissioner of Patents appointed under subsection 4(1) of the Patent Act. (commissaire aux brevets)

“General Council Decision”

“General Council Decision” has the meaning assigned by subsection 30(6) of the Act. (décision du Conseil général)

C.07.002. This Division applies to the sale of drugs for the purposes of implementing the General Council Decision.

C.07.003. An application by a manufacturer for authorization to sell a drug under this Division shall be submitted to the Minister and shall contain the following information and documents:

• (a) a statement that the manufacturer intends to file an application with the Commissioner of Patents under section 21.04 of the Patent Act;

• (b) in respect of a new drug, the submission number and date of filing of the new drug submission or abbreviated new drug submission filed under section C.08.002 or C.08.002.1, respectively, and of any supplement filed under section C.08.003 in respect of the drug;

• (c) in respect of a drug that is not a new drug,

  • (i) the application number and date of filing of the application that has been filed under section C.01.014.1 in respect of the drug, or

  • (ii) the drug identification number, if one has been assigned in respect of the drug pursuant to section C.01.014.2;

• (d) for a drug in a solid dosage form, the manner in which the drug is marked in accordance with paragraph C.07.008(a) and evidence that such manner does not alter the safety and efficacy of the drug;

• (e) for a drug in a dosage form that is not solid, the manner in which the immediate container is marked in accordance with paragraph C.07.008(a); and

• (f) a sample of the label for the drug that includes the information required by paragraph C.07.008(c).

C.07.004. The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the manufacturer’s drug meets the requirements of the Act and these Regulations if

• (a) the manufacturer has submitted to the Minister an application in accordance with section C.07.003 and a copy of the application filed by the manufacturer with the Commissioner of Patents under section 21.04 of the Patent Act;

• (b) in respect of a new drug, an examination of the new drug submission or abbreviated new drug submission or supplement to either submission by the Minister demonstrates that the submission or supplement complies with section C.08.002, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1;

• (c) in respect of a drug that is not a new drug, a drug identification number has been assigned pursuant to section C.01.014.2; and

• (d) the Minister is satisfied that the manufacturer and the drug comply with the Act and these Regulations.