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

Regulations are current to 2017-10-13 and last amended on 2017-06-20. Previous Versions

AMENDMENTS NOT IN FORCE

  • — 2014, c. 20, s. 366(3)

    • Replacement of “trade-mark” in regulations
      • 366 (3) Unless the context requires otherwise, “trade-mark”, “trade-marks”, “Trade-mark”, “Trade-marks”, “trade mark” and “trade marks”, are replaced by “trademark”, “trademarks”, “Trademark” or “Trademarks”, as the case may be, in the English version of any regulation, as defined in subsection 2(1) of the Statutory Instruments Act.

  • — SOR/2017-76, 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 A

      List A means the document, entitled List of Certain Antimicrobial Active Pharmaceutical Ingredients, that is published by the Government of Canada on its website, as amended from time to time; (Liste A)

      List B

      List B means the document, entitled List of Certain Veterinary Drugs Which May Be Imported But Not Sold, that is published by the Government of Canada on its website, as amended from time to time; (Liste B)

      List C

      List C means the document, entitled Veterinary Health Products, that is published by the Government of Canada on its website, as amended from time to time; (Liste C)

      veterinary health product

      veterinary health product means any of the following drugs that is in dosage form and that is not manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms:

      • (a) a substance set out in Column I of Part 1 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of any substances in which all the medicinal ingredients are substances set out in Column I of Part 1 of that list if that combination is, in respect of each of those substances, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those substances;

      • (b) a homeopathic medicine set out in Column I of Part 2 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of homeopathic medicines set out in Column I of Part 2 of that list if that combination is, in respect of each of those homeopathic medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those homeopathic medicines; and

      • (c) a traditional medicine set out in Column I of Part 3 of List C that is consistent with the descriptive information set out in Columns II to V, or any combination of traditional medicines set out in Column I of Part 3 of that list if that combination is, in respect of each of those traditional medicines, consistent with the descriptive information set out in Columns II and III and the descriptive information set out in Columns IV and V that is, within each of those columns, common to those traditional medicines; (produit de santé animale)

  • — SOR/2017-76, s. 2

    • 2 The Regulations are amended by adding the following after section C.01.013:

      • C.01.013.1 Section C.01.013 does not apply in respect of a veterinary health product.

  • — SOR/2017-76, s. 3

    • 3 The Regulations are amended by adding the following after section C.01.014.12:

      • C.01.014.13 Sections C.01.014 to C.01.014.7 do not apply in respect of a veterinary health product.

  • — SOR/2017-76, s. 4

    • 4 The Regulations are amended by adding the following after section C.01.018:

      • C.01.018.1 Section C.01.018 does not apply in respect of a veterinary health product.

  • — SOR/2017-76, s. 5

    • 5 The Regulations are amended by adding the following after section C.01.019:

      • C.01.019.1 Section C.01.019 does not apply in respect of a veterinary health product.

  • — SOR/2017-76, s. 6

    • 6 The Regulations are amended by adding the following after section C.01.611:

        • C.01.612 (1) Every manufacturer or importer who sells a veterinary drug in dosage form that contains an active pharmaceutical ingredient that is set out in List A, or every person who compounds such a drug, shall, in a form established by the Minister, submit to the Minister an annual report identifying for each drug, the total quantity sold or compounded and an estimate of the quantity sold or compounded for each intended animal species.

        • (2) The annual report described in subsection (1) is for a period of one calendar year and shall be submitted on or before March 31 of the year following the calendar year covered by the report, beginning with the first full calendar year after the day on which this section comes into force.

        • C.01.613 (1) No person shall import a drug into Canada for the purpose of administering it to an animal that produces food or an animal that is intended for consumption as food if the sale of the drug in Canada would constitute a violation of the Act or these Regulations.

        • (2) Subsection (1) does not apply to a drug that is described in List B.

        • C.01.614 (1) Sections 43 to 58 of the Natural Health Products Regulations apply in relation to a veterinary health product, as if that product were a natural health product as defined in subsection 1(1) of those Regulations.

        • (2) A veterinary health product shall display, on the principal display panel of the inner and outer label, the statement: “Veterinary Health Product / Produit de santé animale” or “Produit de santé animale / Veterinary Health Product”.

        • (3) Section C.01.600 and paragraph C.01.604(b) do not apply in respect of a veterinary health product.

        • C.01.615 (1) Every manufacturer or importer of a veterinary health product shall notify the Minister of the sale of that product in Canada at least 30 days before the day on which that sale is commenced.

        • (2) The notification shall be in a form established by the Minister and contain the following information:

          • (a) the name, mailing address, telephone number and email address of the manufacturer or importer;

          • (b) the brand name under which the veterinary health product is sold;

          • (c) the pharmaceutical form in which the veterinary health product is sold;

          • (d) the strength per dosage unit;

          • (e) the route of administration;

          • (f) a quantitative list of the medicinal ingredients and a qualitative list of the non-medicinal ingredients;

          • (g) the species of animal for which the veterinary health product is recommended; and

          • (h) the use or purpose for which the veterinary health product is recommended.

        • (3) A manufacturer or importer who has provided the Minister with a notification under subsection (1) shall provide the Minister with any changes to the information required under subsection (2), in a form established by the Minister, at least 30 days before the day on which the veterinary health product to which the changes relate is sold.

      • C.01.616 If the Minister has reasonable grounds to believe that a veterinary health product may no longer be safe, the Minister may request that the manufacturer or importer of the veterinary health product provide the Minister, within 15 days after the day on which the request is received, with information and documents demonstrating that the veterinary health product is safe.

        • C.01.617 (1) The Minister may direct the manufacturer or importer to stop the sale of a veterinary health product if

          • (a) the manufacturer or importer does not, within the required period, provide the Minister with the information and documents requested under section C.01.616;

          • (b) the information and documents provided by the manufacturer or importer in accordance with section C.01.616 do not demonstrate that the veterinary health product is safe; or

          • (c) the Minister has reasonable grounds to believe that the sale of the veterinary health product would be a violation of the Act or these Regulations.

        • (2) The Minister shall lift a direction to stop the sale of a veterinary health product if the manufacturer or importer provides the Minister with information and documents demonstrating that

          • (a) in the case of a direction to stop a sale under either paragraph (1)(a) or (b), the veterinary health product is safe;

          • (b) in the case of a direction to stop a sale under paragraph 1(c), the sale of the veterinary health product would no longer be a violation of the Act or these Regulations; or

          • (c) the situation giving rise to the direction to stop the sale of the veterinary health product did not exist.

  • — SOR/2017-76, s. 7

    • 7 Subsection C.01A.001(2) of the Regulations is replaced by the following:

      • (2) In this Division and in Division 2, drug does not include any of the following:

        • (a) a dilute drug premix;

        • (b) a medicated feed as defined in subsection 2(1) of the Feeds Regulations, 1983;

        • (c) an active ingredient that is for veterinary use and that is not an active pharmaceutical ingredient;

        • (d) an active pharmaceutical ingredient for veterinary use that is not required to be sold pursuant to a prescription and that is also a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations;

        • (e) a drug that is used only for the purposes of an experimental study in accordance with a certificate issued under section C.08.015.

  • — SOR/2017-76, s. 8

      • (1) The portion of paragraph C.01A.002(1)(b) of the Regulations before subparagraph (i) is replaced by the following:

        • (b) subject to subsection (3), importing or compounding, pursuant to a prescription, a drug that is not commercially available in Canada by one of the following persons:

      • (2) Section C.01A.002 of the Regulations is amended by adding the following after subsection (1):

        • (1.1) This Division and Division 2 do not apply to a veterinary health product or an active pharmaceutical ingredient that is used in the fabrication of a veterinary health product.

      • (3) Section C.01A.002 of the Regulations is amended by adding the following after subsection (2):

        • (3) This Division applies to the importing, by a pharmacist, a veterinary practitioner or a person who compounds a drug under the supervision of a veterinary practitioner, of an active pharmaceutical ingredient for veterinary use that is for the purpose of compounding, pursuant to a prescription, a drug in dosage form that is not commercially available in Canada, if that ingredient is set out in List A.

  • — SOR/2017-76, s. 9

    • 9 Table II to section C.01A.008 of the Regulations is amended by adding the following after item 6:

      TABLE II

      ItemCategories of Drugs
      7Active pharmaceutical ingredients set out in List A that are for veterinary use
  • — SOR/2017-76, s. 10

    • 10 Section C.08.001 of the Regulations is replaced by the following:

      • C.08.001 For the purposes of the Act and this Division, new drug means a drug, other than a veterinary health product,

        • (a) that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;

        • (b) that is a combination of two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined in that drug, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or

        • (c) with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration or duration of action, and that has not been sold for that use or condition of use in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug.

  • — SOR/2017-76, s. 11

      • 11 (1) In this section, fabricate, package/label, import and active pharmaceutical ingredient have the same meaning as in subsection C.01A.001(1) of the Food and Drug Regulations.

      • (2) Every person who, on or before the day on which section 7, subsections 8(1) and (3) and section 9 of these Regulations come into force, fabricates, packages/labels, tests or imports an active pharmaceutical ingredient for veterinary use may continue to do so without an establishment licence if they submit an application for a licence under section C.01A.005 of the Food and Drug Regulations within 14 months after that day.

      • (3) Subsection (2) applies until the determination of the licence application is made under section C.01A.008 or C.01A.010 of the Food and Drug Regulations.

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