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

• C.10.002 (1) A sale of a drug that is imported under subsection C.10.001(2) is exempt from the provisions of these Regulations only if the drug is sold to a person within the jurisdiction of a public health official who has notified the Minister as described in paragraph C.10.001(2)(a), for use in respect of the same urgent public health need for which it was imported.

• (2) Any person who wholesales such a drug must hold an establishment licence to wholesale a drug in the same category and despite subsection (1), the following provisions apply in respect of the wholesale:

  • (a) sections C.02.003.1 and C.02.004 as they apply to the storage of the drug by the licensee;

  • (b) section C.02.006 as it applies to the storage of the drug by the licensee;

  • (c) subsection C.02.012(1);

  • (c.1) section C.02.012.1 as it applies to the storage of the drug by the licensee;

  • (d) section C.02.013;

  • (d.1) section C.02.014;

  • (e) section C.02.015 as it applies to the storage and transportation of the drug by the licensee;

  • (e.1) subsection C.02.021(1) as it applies to storage;

  • (f) subsection C.02.022(1);

  • (f.1) [Repealed, SOR/2023-247, s. 7]

  • (g) section C.02.023; and

  • (h) subsection C.02.024(1).

C.10.003 Every licensee who imports a drug under subsection C.10.001(2) must notify the Minister within 15 days after the day on which it is imported by providing the following information:

• (a) the name, title and contact information of the person who imported the drug;

• (b) the brand name of the drug;

• (c) the medicinal ingredients, strength, dosage form and route of administration of the drug and any identifying code or number assigned to it in the country in which it was authorized for sale;

• (d) the name of the country from which the drug was imported; and

• (e) the total quantity of the drug imported.

Drugs for Exceptional Importation and Sale

• C.10.004 (1) The following definitions apply in this section and in sections C.10.005 to C.10.013.

  business day

  business day means a day other than

  • (a) a Saturday; or

  • (b) a Sunday or other holiday. (jour ouvrable)

  designated drug

  designated drug means

  • (a) a drug that is set out in Part 1 of the List of Drugs for Exceptional Importation and Sale; and

  • (b) a lot or batch of a drug that is set out in Part 2 of that list. (drogue désignée)

  drug

  drug[Repealed, SOR/2026-96, s. 15]

  foreign regulatory authority

  foreign regulatory authority has the same meaning as in subsection C.10.001(1). (autorité réglementaire étrangère)

  List of Drugs for Exceptional Importation and Sale

  List of Drugs for Exceptional Importation and Sale means the List of Drugs for Exceptional Importation and Sale that is published by the Government of Canada on its website, as amended from time to time. (Liste des drogues destinées aux importations et aux ventes exceptionnelles)

• (2) In sections C.10.005 to C.10.013, batch certificate, fabricate, import, MRA country, package/label, recognized building and wholesaler have the same meanings as in subsection C.01A.001(1).

• (3) In this section and sections C.10.006 and C.10.009,

  • (a) specifications has the same meaning as in section C.02.002; and

  • (b) a reference to specifications is a reference to the specifications with which the designated drug is required to comply within the jurisdiction of the foreign regulatory authority referred to in paragraph C.10.006(1)(b).

• (4) The definition expiration date in subsection C.01.001(1) does not apply in respect of a designated drug referred to in subsection C.10.007.4(1).

• C.10.005 (1) Subject to subsection (3), the Minister may add a drug that is fabricated outside Canada to Subpart 1 or 2 of Part 1 of the List of Drugs for Exceptional Importation and Sale only if

  • (a) either of the following conditions is met in respect of another drug:

    • (i) the Minister has reasonable grounds to believe that there is a shortage or risk of shortage of the other drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and not been cancelled, or

    • (ii) the sale of the other drug was discontinued;

  • (b) the Minister has reasonable grounds to believe that

    • (i) a shortage of the other drug if it were to occur, or the discontinuation of sale of it could present a risk of injury to human health,

    • (ii) the drug to be added to that list can be substituted for the other drug, and

    • (iii) the drug to be added to that list is authorized to be sold by a foreign regulatory authority within its jurisdiction; and

  • (c) in the case referred to in subparagraph (a)(ii), the drug to be added to that list is added on or before the day that is 36 months after the day on which the sale of the other drug was discontinued.

• (2) Subject to subsection (3), the Minister may add a lot or batch of a drug that is fabricated in Canada to Subpart 1 or 2 of Part 2 of the List of Drugs for Exceptional Importation and Sale only if

  • (a) either of the following conditions is met in respect of another drug:

    • (i) the Minister has reasonable grounds to believe that there is a shortage or risk of shortage of the other drug for which a drug identification number has been assigned under subsection C.01.014.2(1) and not been cancelled, or

    • (ii) the sale of the other drug was discontinued; and

  • (b) the Minister has reasonable grounds to believe that

    • (i) a shortage of the other drug, if it were to occur, or the discontinuation of sale of it could present a risk of injury to human health, and

    • (ii) the lot or batch of the drug to be added to that list meets the following conditions:

      • (A) it can be substituted for the other drug,

      • (B) it is authorized to be sold by a foreign regulatory authority within its jurisdiction,

      • (C) it is fabricated for consumption or use outside Canada, and

      • (D) despite clause (C), it is no longer intended for export.

• (3) The Minister may add a drug to Subpart 2 of Part 1 of the List of Drugs for Exceptional Importation and Sale — or a lot or batch of a drug to Subpart 2 of Part 2 of that list — only if

  • (a) the drug is for human use;

  • (b) the drug is not one of the following drugs:

    • (i) a drug included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act,

    • (ii) a prescription drug,

    • (iii) a drug listed in Schedule C or D to the Act, or

    • (iv) a drug that is permitted to be sold without a prescription but that is to be administered only under the supervision of a practitioner; and

  • (c) the Minister has reasonable grounds to believe that use of the drug can cause injury to human health or present a risk to public health and the injury or risk can be mitigated by the supervision of a practitioner or pharmacist.

C.10.005.1 For greater certainty, if a lot or batch of a drug is set out in Part 1 or 2 of the List of Drugs for Exceptional Importation and Sale, sections C.10.006 to C.10.013 apply only in respect of that lot or batch.

• 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]

C.10.007 Section A.01.044 does not apply in respect of the importation of a designated drug under section C.10.006.

• C.10.007.1 (1) Despite sections C.01.003, C.01.014 and C.08.002 and subject to subsections (3), (4) and (6), a person who holds an establishment licence may sell a designated drug that is set out in Part 2 of the List of Drugs for Exceptional Importation and Sale for consumption or use in Canada if the conditions set out in subsection (2) are met and, as the case may be,

  • (a) they are the distributor of the drug for consumption or use outside Canada; or

  • (b) they are a wholesaler of a drug.

• (2) The conditions are the following:

  • (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 licensee first sells the designated drug for consumption or use in Canada, 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, and

    • (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;

  • (b) if the licensee meets the condition set out in paragraph (1)(b) and the designated drug is referred to in any of paragraphs (a), (c) or (d) of the definition wholesaler in subsection C.01A.001(1), the drug is in the same category as the category for which the establishment licence was issued;

  • (c) the following information in respect of the designated drug is set out in Part 2 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 clause C.10.005(2)(b)(ii)(B),

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

    • (v) the date after which the licensee is no longer permitted to sell the drug, if applicable, and

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

  • (d) the licensee ensures that the information referred to in clause (a)(iii)(G) is available in English and French and in a manner that permits the safe use of the designated drug; and

  • (e) the licensee has prepared a plan that specifies the measures to be taken in order for them to comply with paragraph (d).

• (3) The licensee shall not sell, in total, the designated drug in a quantity that exceeds the maximum limit referred to in subparagraph (2)(c)(iv), if applicable.

• (4) The licensee shall not sell the designated drug after the date referred to in subparagraph (2)(c)(v), if applicable.

• (5) The licensee shall ensure that the information referred to in clause (2)(a)(iii)(G) is available in accordance with paragraph (2)(d) until at least the latest expiration date of the designated drug that they sold.

• (6) This section does not apply — in respect of a designated drug sold by the licensee under subsection (1) — to another person who holds an establishment licence and sells the drug.