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  • (f.1) [Repealed, SOR/2023-247, s. 7]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

• C.10.004 (1) The following definitions apply in this section and in sections C.10.005 to C.10.011.

  designated drug

  designated drug means a drug that is set out in the List of Drugs for Exceptional Importation and Sale. (drogue désignée)

  drug

  drug means any of the following drugs for human use:

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

  • (b) prescription drugs;

  • (c) drugs that are listed in Schedule C or D to the Act; and

  • (d) drugs that are permitted to be sold without a prescription but that are to be administered only under the supervision of a practitioner. (drogue)

  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.10.006 and C.10.009, batch certificate, fabricate, MRA country, package/label and recognized building have the same meanings as in subsection C.01A.001(1).

• C.10.005 (1) The Minister may add a drug to the List of Drugs for Exceptional Importation and Sale only if the Minister has reasonable grounds to believe that

  • (a) there is a shortage or risk of shortage of another drug for which a notice of compliance has been issued under section C.08.004 or C.08.004.01 or for which a drug identification number has been assigned under subsection C.01.014.2(1); and

  • (b) the drug to be added to that list can be substituted for the drug referred to in paragraph (a).

• (2) In subsection (1), shortage has the same meaning as in section C.01.014.8.

• 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.

C.10.007 Sections A.01.040, A.01.044 and C.01.004.1 do not apply in respect of the importation, under section C.10.006, of a designated drug by a person who holds an establishment licence.

• C.10.008 (1) Subject to sections C.10.009 and C.10.010, a sale of a designated drug that is imported under section C.10.006 is exempt from the following provisions:

  • (a) sections A.01.015, A.01.017 and A.01.051; and

  • (b) the provisions of Part C other than

    • (i) sections C.01.016, C.01.017, C.01.019 to C.01.020.1, C.01.040.3 to C.01.049.1 and C.01.051,

    • (ii) the provisions of Divisions 1A and 2, and

    • (iii) this section and sections C.10.009 to C.10.011.

• (2) For greater certainty, for the purposes of section C.01.016, the manufacturer of a designated drug is required to comply only with the requirements set out in sections C.01.017 and C.01.019 in respect of the drug.

• (3) Subsections (1) and (2) cease to apply in respect of the sale of a designated drug on its expiration date.

• C.10.009 (1) Section C.02.019 does not apply to a person who holds an establishment licence in respect of a designated drug that they import under section C.10.006.

• (2) The licensee shall perform the finished product testing on a sample of the designated drug that is taken either

  • (a) after receipt of each lot or batch of the designated drug on their premises in Canada; or

  • (b) before receipt of each lot or batch of the designated drug on their premises in Canada if the following conditions are met:

    • (i) the licensee has evidence satisfactory to the Minister to demonstrate that lots or batches of the designated drug sold to them by the vendor of the lot or batch are consistently manufactured in accordance with and consistently comply with the specifications for that drug, and

    • (ii) the designated drug has not been transported or stored under conditions that may affect its compliance with the specifications for that drug.

• (3) In subsection (2), 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) If the licensee receives on their premises in Canada a lot or batch of a designated drug whose useful life is more than 30 days, they shall visually inspect the lot or batch to confirm the identity of the product.

• (5) Subsections (2) and (4) do not apply to the licensee if the designated drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and the following conditions are met:

  • (a) the address of the building is set out in their establishment licence; and

  • (b) they retain a copy of the batch certificate for each lot or batch of the designated drug that they receive for at least one year after the expiration date of the lot or batch.

• (6) In this section, specifications has the same meaning as in section C.02.002.

• C.10.010 (1) A person who holds an establishment license and who imports a designated drug under section C.10.006 is required to comply with paragraphs C.02.020(1)(a), (b) and (d) in respect of the drug but is not required to maintain the records referred to in those paragraphs on their premises in Canada.

• (2) The Minister may request that the licensee provide to the Minister any of the records referred to in paragraphs C.02.020(1)(a), (b) or (d) in respect of the designated drug.

• (3) The licensee shall provide the requested records electronically in a format specified by or acceptable to the Minister within the time limit specified by the Minister.

• C.10.011 (1) A person who holds an establishment licence shall not sell a designated drug that they imported under section C.10.006 unless they ensure that the information referred to in clause C.10.006(1)(a)(iii)(G) is available in English and French and in a manner that permits the safe use of the drug.

• (2) The licensee shall ensure that the information is available in accordance with subsection (1) until at least the end of the day on the latest expiration date of the designated drug that they imported.

DIVISION 11Public or Canadian Armed Forces Health Emergencies — Drugs for Immediate Use or Stockpiling

• C.11.001 (1) The following definitions apply in this Division.

  foreign regulatory authority

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

  initial public health official

  initial public health official means the public health official named in an authorization issued under subsection C.11.003(1). (responsable de la santé publique initial)

  public health official

  public health official means

  • (a) the Chief Public Health Officer appointed under subsection 6(1) of the Public Health Agency of Canada Act;

  • (b) the Chief Medical Officer of Health, or equivalent, of a province;

  • (c) the Medical Officer of Health, or equivalent, of a municipality;

  • (d) the Surgeon General of the Canadian Armed Forces; or

  • (e) the Chief Medical Officer of Public Health for the Department of Indigenous Services. (responsable de la santé publique)

  subsequent public health official

  subsequent public health official means any public health official, other than the initial public health official, who obtains the quantity of a drug, or a portion of the quantity, that is specified in an authorization issued under subsection C.11.003(1). (responsable de la santé publique subséquent)

• (2) This Division applies to a drug for human use in dosage form for which a drug identification number has not been assigned under subsection C.01.014.2(1) or for which a notice of compliance has not been issued under section C.08.004 or C.08.004.01, including drugs that have ceased to be considered to be natural health products by virtue of subsection 103.15(2) of the Natural Health Products Regulations.