Food and Drug Regulations

C.10.006 (1) Despite sections A.01.040 and C.01.004.1, a person who holds an establishment licence that authorizes the importation of a drug may import a designated drug set out in Part 1 of the List of Drugs for Exceptional Importation and Sale if the following conditions are met:

• (a) the licensee provides the Minister, in the form and manner specified by the Minister and not later than three business days before the day on which the 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 drug and the address of each building in which it is fabricated, packaged/labelled or tested,

  • (iii) in respect of the 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 drug, and

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

• (b) the licensee provides the Minister with an attestation, signed and dated by an individual who has authority to bind the licensee, that confirms that the licensee possesses or has immediate access to the specifications for the drug;

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

• (d) the following information in respect of the drug is set out in Part 1 of the List of Drugs for Exceptional Importation and Sale:

  • (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 subparagraph C.10.005(1)(b)(iii),

  • (iv) the maximum limit for the total quantity of the drug that the licensee may import, if applicable,

  • (v) the date after which the drug may no longer be imported, if applicable, and

  • (vi) the lot or batch number of the drug, if applicable;

• (e) [Repealed, SOR/2026-96, s. 17]

• (f) the total quantity of the drug that the licensee imports does not exceed the maximum limit referred to in subparagraph (d)(iv), if applicable;

• (g) the drug is imported on or before the date referred to in subparagraph (d)(v), if applicable; 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) [Repealed, SOR/2026-96, s. 17]