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

Regulations are current to 2020-07-28 and last amended on 2019-12-16. Previous Versions

AMENDMENTS NOT IN FORCE

  • — SOR/2020-73, s. 1

      • 1 (1) The portion of the definition batch certificate in subsection C.01A.001(1) of the Food and Drug RegulationsFootnote 1 before paragraph (a) is replaced by the following:

        batch certificate

        batch certificate means a certificate issued by the fabricator of a lot or batch of a drug that is either imported within the framework of a mutual recognition agreement or referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, and in which the fabricator

      • (2) Paragraph (e) of the definition batch certificate in subsection C.01A.001(1) of the Regulations is replaced by the following:

        • (e) certifies that the lot or batch was fabricated, packaged/labelled and tested

          • (i) in the case of a drug that is imported within the framework of a mutual recognition agreement, in accordance with the good manufacturing practices of the regulatory authority that has recognized those buildings as meeting its good manufacturing practices standards, or

          • (ii) in the case of a drug that is not imported within the framework of a mutual recognition agreement and that is referred to on the List of Non-prescription Drugs Not Subject to Certain Testing Requirements, in accordance with the requirements of Division 2. (certificat de lot)

      • (3) Subsection C.01A.001(1) of the Regulations is amended by adding the following in alphabetical order:

        List of Non-prescription Drugs Not Subject to Certain Testing Requirements

        List of Non-prescription Drugs Not Subject to Certain Testing Requirements means the document entitled List of Non-prescription Drugs for Which the Testing Requirements Set Out in Subsections C.02.019(1) and (2) of the Food and Drug Regulations Do Not Apply that is published by the Government of Canada on its website, as amended from time to time. (Liste de drogues vendues sans ordonnance et non soumises à certaines analyses)

        recognized country or region

        recognized country or region means a country or region that is set out in the document entitled List of Foreign Countries or Regions and Their Regulatory Authorities for the Application of Subsection C.02.019(5) of the Food and Drug Regulations, published by the Government of Canada on its website, as amended from time to time. (pays ou régions reconnus)

  • — SOR/2020-73, s. 2

    • 2 Subsection C.02.019(4) of the Regulations is replaced by the following:

      • (4) Subsections (1) and (2) do not apply to a distributor or importer if the drug is fabricated, packaged/labelled and tested in an MRA country at a recognized building and they retain a copy of the batch certificate for each lot or batch of the drug that they receive.

      • (5) Subsections (1) and (2) do not apply to a distributor or importer of a drug that is not a prescription drug and that is part of a class of drugs that is set out in column 1 of the List of Non-prescription Drugs Not Subject to Certain Testing Requirements if all of the following conditions are met:

        • (a) the drug contains, as its only active ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6;

        • (b) the drug is

          • (i) fabricated in Canada or in a recognized country or region,

          • (ii) packaged/labelled in Canada or in a recognized country or region, and

          • (iii) tested in a recognized country or region;

        • (c) the distributor or the importer retains a copy of the batch certificate for each lot or batch of the drug that is distributed or imported, as the case may be.

      • (6) A drug that is referred to in subsection (5) may be shipped directly to a person other than an importer if all of the following conditions are met:

        • (a) before importing the drug, the importer receives a document that demonstrates that the drug complies with the specifications for that drug;

        • (b) the importer and the distributor have measures in place to ensure that all the requirements of these Regulations in respect of the importation of the drug are met.

  • — SOR/2020-74, s. 1

    • 1 Subsection C.01.001(1) of the Food and Drug RegulationsFootnote 1 is amended by adding the following in alphabetical order:

      List D

      List D means the document entitled List of Certain Non-prescription Drugs for Distribution as Samples that is published by the Government of Canada on its website, as amended from time to time; (Liste D)

  • — SOR/2020-74, s. 2

    • 2 The Regulations are amended by adding the following before section C.01.048:

      Distribution of Drugs as Samples

  • — SOR/2020-74, s. 3

      • 3 (1) The portion of subsection C.01.048(1) of the Regulations before paragraph (a) is replaced by the following:

          • C.01.048 (1) If a practitioner or pharmacist has signed an order specifying the proper name or common name, the brand name and the quantity of a drug, other than the following, the person who receives the order may distribute or cause to be distributed the drug, in dosage form, as a sample to that practitioner or pharmacist if the drug meets the requirements of these Regulations:

      • (2) Subsection C.01.048(1) of the Regulations is amended by adding “or” at the end of paragraph (b) and by repealing paragraph (c).

      • (3) Section C.01.048 of the Regulations is amended by adding the following after subsection (1):

        • (1.1) A person may distribute or cause to be distributed a prescription drug as a sample under subsection (1) only to a practitioner or pharmacist who is entitled, under the laws of the province in which they are practising, to prescribe or dispense that drug, as the case may be.

      • (4) Section C.01.048 of the Regulations is amended by adding the following after subsection (2):

        • (3) Despite subsection (1), a person may distribute or cause to be distributed a drug, in dosage form, as a sample to a practitioner or pharmacist without a signed order if that drug is not a prescription drug and is part of a class of drugs that is set out in column 1 of List D, and if all of the following conditions are met:

          • (a) the drug contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6;

          • (b) the expiration date of the drug falls on a day that is

            • (i) at least 30 days after the day on which it is distributed, if the expiration date consists of a day, month and year, or

            • (ii) in a month that follows the month in which it is distributed, if the expiration date consists only of a month and year;

          • (c) the drug meets the requirements of these Regulations.

  • — SOR/2020-74, s. 4

    • 4 The portion of section C.01.049 of the Regulations before paragraph (a) is replaced by the following:

      • C.01.049 A person who, under subsection C.01.048(1), receives an order for and distributes or causes to be distributed a drug as a sample shall

  • — SOR/2020-74, s. 5

    • 5 The Regulations are amended by adding the following after C.01.049:

      • C.01.049.1 A person may distribute or cause to be distributed a drug, in dosage form, as a sample to any consumer that is 18 years of age or older if that drug is not a prescription drug and is part of a class of drugs that is set out in column 1 of List D, and if all of the following conditions are met:

        • (a) the drug contains, as its only medicinal ingredients, one or more of those set out in column 2, each of which corresponds to that class, in the corresponding quantity set out in column 3, and the drug is consistent with the descriptive information set out in columns 4 to 6;

        • (b) the expiration date of the drug falls on a day that is

          • (i) at least 30 days after the day on which it is distributed, if the expiration date consists of a day, month and year, or

          • (ii) in a month that follows the month in which it is distributed, if the expiration date consists only of a month and year;

        • (c) the drug meets the requirements of these Regulations.

  • — SOR/2020-74, s. 6

    • 6 Subsection C.08.004.1(2) of the Regulations is replaced by the following:

      • (2) The purpose of this section is to implement Articles 20.48 and 20.49 of the Agreement between Canada, the United States of America and the United Mexican States, as defined in the definition Agreement in section 2 of the Canada–United States–Mexico Agreement Implementation Act, and paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the Agreement Establishing the World Trade Organization, as defined in the definition Agreement in subsection 2(1) of the World Trade Organization Agreement Implementation Act.

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