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

C.07.005. Despite sections C.01.014, C.08.002 and C.08.003, a manufacturer may sell a drug under this Division if

• (a) the Minister has notified the Commissioner of Patents for the purposes of paragraph 21.04(3)(b) of the Patent Act that the drug meets the requirements of the Act and these Regulations; and

• (b) the manufacturer has received authorization under section 21.04 of the Patent Act.

C.07.006. Sections C.01.005 and C.01.014.1 to C.01.014.4 do not apply to new drugs sold under this Division.

C.07.007. The Minister shall notify the manufacturer and the Commissioner of Patents for the purposes of paragraph 21.13(b) of the Patent Act in the event that the Minister is of the opinion that the manufacturer’s drug authorized to be sold under this Division has ceased to meet the requirements of the Act and these Regulations.

C.07.008. No person shall sell a drug under this Division unless

• (a) the drug itself permanently bears the mark “XCL”, in the case of a drug in a solid dosage form, or the immediate container permanently bears the mark “XCL”, in the case of a drug in a dosage form that is not solid;

• (b) the colour of the drug itself is significantly different from the colour of the version of the drug sold in Canada, in the case of a drug in a solid dosage form; and

• (c) the label of the drug permanently bears the mark “XCL”, followed by the export tracking number assigned by the Minister under section C.07.009 and the words “FOR EXPORT UNDER THE GENERAL COUNCIL DECISION. NOT FOR SALE IN CANADA.” or “POUR EXPORTATION AUX TERMES DE LA DÉCISION DU CONSEIL GÉNÉRAL. VENTE INTERDITE AU CANADA.”

C.07.009. The Minister shall assign an export tracking number to each drug in respect of which the Minister has notified the Commissioner of Patents under section C.07.004.

C.07.010. The manufacturer shall, with respect to a drug authorized to be sold under this Division,

• (a) establish and maintain records, in a manner that enables an audit to be made, respecting the information described in section C.08.007; and

• (b) provide to the Minister the reports referred to in section C.08.008.

C.07.011. The manufacturer shall notify the Minister in writing not less than 15 days before commencing the manufacture of the first lot of a drug authorized to be sold under this Division and not less than 15 days before the exportation of each subsequent lot of the drug.