Food and Drug Regulations

C.10.006 (1) A person who holds an establishment licence that authorizes the importation of a drug may import a designated drug if the following conditions are met:

• (a) the licensee provides the Minister, electronically in a format specified by or acceptable to the Minister and not later than the third business day before the day on which the designated drug is imported, with a notification that contains the following information:

  • (i) the licensee’s name and contact information,

  • (ii) the name and contact information of each fabricator, packager/labeller and tester of the designated drug and the address of each building in which it is fabricated, packaged/labelled or tested,

  • (iii) in respect of the designated drug,

    • (A) its brand name,

    • (B) its medicinal ingredients,

    • (C) its dosage form,

    • (D) its strength,

    • (E) its route of administration,

    • (F) its identifying code or number, if any, assigned in the country in which it is authorized for sale, and

    • (G) a detailed description of its conditions of use,

  • (iv) the intended port of entry into Canada,

  • (v) the estimated date of arrival of the shipment of the designated drug, and

  • (vi) the total quantity of the designated drug that is intended to be imported on the date referred to in subparagraph (v);

• (b) the designated drug is authorized to be sold by a foreign regulatory authority within its jurisdiction;

• (c) the designated drug is in the same category as the category for which the establishment licence was issued;

• (d) the following information is set out in the List of Drugs for Exceptional Importation and Sale in respect of the designated drug:

  • (i) the licensee’s name,

  • (ii) the information referred to in clauses (a)(iii)(A) to (F),

  • (iii) the name of the foreign regulatory authority referred to in paragraph (b), and

  • (iv) the date after which it may no longer be imported;

• (e) the lot number of the designated drug is set out in the list referred to in paragraph (d), if applicable;

• (f) the total quantity of the designated drug that the licensee imports does not exceed the maximum limit specified in the list referred to in paragraph (d) in respect of the drug, if applicable;

• (g) the designated drug is imported on or before the date referred to in subparagraph (d)(iv); and

• (h) the licensee has prepared a plan that specifies the measures to be taken in order for the licensee to comply with section C.10.011.

(2) In subsection (1), business day means a day other than

• (a) a Saturday; or

• (b) a Sunday or other holiday.