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

Regulations are current to 2022-06-01 and last amended on 2022-03-02. Previous Versions

PART CDrugs (continued)

DIVISION 1AEstablishment Licences (continued)

Application

  •  (1) This Division does not apply to

    • (a) wholesaling a drug premix;

    • (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:

      • (i) a pharmacist,

      • (ii) a practitioner, and

      • (iii) a person who compounds a drug under the supervision of a practitioner;

    • (b.1) any activity with respect to a positron-emitting radiopharmaceutical that is used only for the purposes of a basic clinical research study described in section C.03.304;

    • (c) any activity with respect to a drug that is used only for the purposes of clinical testing in accordance with subsection C.05.006(1) or section C.08.005;

    • (d) fabricating, packaging/labelling, testing as required under Division 2, distributing as a distributer referred to in section C.01A.003, wholesaling or importing any of the following drugs for which prescriptions are not required and that are for human use in dosage form and not represented as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states set out in Schedule A.1 to the Act, namely,

      • (i) homeopathic drugs,

      • (ii) drugs that meet the requirements of a class monograph entitled “Vitamin Supplements”, “Mineral Supplements”, “Dietary Vitamin Supplements” or “Dietary Mineral Supplements”, as the case may be, and

      • (iii) drugs that

        • (A) contain a plant, mineral or animal substance in respect of which therapeutic activity or disease prevention activity is claimed, including traditional herbal medicines, traditional Chinese medicines, ayurvedic (East Indian) medicines and traditional aboriginal (North American) medicines, and

        • (B) the medical use of which is based solely on historical and ethnological evidence from references relating to a medical system other than one based on conventional scientific standards; and

    • (e) fabricating, packaging/labelling, testing, distributing, and importing of antimicrobial agents.

  • (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.

  • (2) This Division and Divisions 2 to 4 do not apply to the affixing of a label to a previously labelled container.

  • (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/97-12, s. 5
  • SOR/98-7, s. 2
  • SOR/2001/-203, s. 1
  • SOR/2004-282, s. 2
  • SOR/2012-129, s. 1
  • SOR/2017-76, s. 8
  • SOR/2021-46, s. 10

 This Division and Divisions 2 to 4 apply to the following distributors:

  • (a) a distributor of an active ingredient; and

  • (b) a distributor of a drug for which the distributor holds the drug identification number.

  • SOR/97-12, s. 5
  • SOR/2002-368, s. 2
  • SOR/2013-74, s. 3
  • SOR/2017-259, s. 12

Prohibition

  •  (1) Subject to subsection (2), no person shall, except in accordance with an establishment licence,

    • (a) fabricate, package/label or import a drug;

    • (b) perform the tests, including examinations, required under Division 2;

    • (c) distribute as a distributor referred to in section C.01A.003 a drug that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act; or

    • (d) wholesale a drug that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act.

  • (2) A person does not require an establishment licence to perform tests under Division 2 if the person holds an establishment licence as a fabricator, a packager/labeller, a distributor referred to in paragraph C.01A.003(b) or an importer.

  • (3) No person shall carry on an activity referred to in subsection (1) unless the person holds

    • (a) in respect of a narcotic as defined in the Narcotic Control Regulations, a licence for that narcotic under those Regulations;

    • (b) in respect of a controlled drug as defined in section G.01.001, a licence for that drug under Part G; or

    • (c) in respect of a drug containing cannabis as defined in subsection 2(1) of the Cannabis Act, a licence for that drug to conduct that activity under the Cannabis Regulations.

  • SOR/97-12, s. 5
  • SOR/2002-368, s. 3
  • SOR/2013-74, s. 4
  • SOR/2017-259, s. 13
  • SOR/2018-144, s. 368
  • SOR/2019-171, s. 24

Application

[
  • SOR/2011-81, s. 1(E)
]
  •  (1) A person who wishes to apply for an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the following information and documents:

    • (a) the applicant’s name, address and telephone number, and their facsimile number and electronic mail address, if any;

    • (b) the name and telephone number, and the facsimile number and electronic mail address, if any, of a person to contact in case of an emergency;

    • (c) each activity set out in Table I to section C.01A.008 for which the licence is requested;

    • (d) each category of drugs set out in Table II to section C.01A.008 for which the licence is requested;

    • (e) each dosage form class in respect of which the applicant proposes to carry out a licensed activity, and whether it will be in a sterile dosage form;

    • (f) whether the applicant proposes to carry out a licensed activity in respect of an active ingredient;

    • (g) the address of each building in Canada in which the applicant proposes to fabricate, package/label, test as required under Division 2 or store drugs, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form;

    • (h) the address of each building in Canada at which records will be maintained;

    • (i) whether any building referred to in paragraphs (g) and (h) is a dwelling-house;

    • (j) the drug identification number, if any, or a name that clearly identifies the drug,

      • (i) for each narcotic as defined in the Narcotic Control Regulations, each controlled drug as defined in section G.01.001 or each drug containing cannabis as defined in subsection 2(1) of the Cannabis Act for which the licence is requested, and

      • (ii) for each other drug within a category of drugs for which the licence is requested, unless the licence is to perform tests required under Division 2, distribute as set out in paragraph C.01A.003(a), or wholesale;

    • (k) if any of the buildings referred to in paragraph (g) have been inspected under the Act or these Regulations, the date of the last inspection;

    • (l) evidence that the applicant’s buildings, equipment and proposed practices and procedures meet the applicable requirements of Divisions 2 to 4;

    • (m) in the case of an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building,

      • (i) the name and address of each fabricator, packager/labeller and tester of the drug and the address of each building in which the drug is fabricated, packaged/labelled or tested, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form,

      • (ii) in respect of each activity done in an MRA country at a recognized building, the name of the regulatory authority that is designated under subsection C.01A.019(1) in respect of that activity for that drug and that has recognized that building as meeting its good manufacturing practices standards in respect of that activity for that drug, and

      • (iii) in respect of any other activities,

        • (A) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or

        • (B) other evidence establishing that the fabricator’s, packager/labeller’s or tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4;

    • (n) in the case of any other importer, the name and address of each fabricator, packager/labeller and tester of the drugs proposed to be imported and the address of each building in which the drugs will be fabricated, packaged/labelled and tested, specifying for each building the activities and the categories of drugs and, for each category, the dosage form classes, if any, and whether any drug will be in a sterile form; and

    • (o) in the case of an importer referred to in paragraph (n),

      • (i) a certificate from a Canadian inspector indicating that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4, or

      • (ii) other evidence establishing that the fabricator’s, packager/labeller’s and tester’s buildings, equipment, practices and procedures meet the applicable requirements of Divisions 2 to 4.

  • (2) In addition to the information and documents referred to in subsection (1), a person who submits an application for an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 to be carried out in respect of a category of drugs set out in Table II to that section that includes a COVID-19 drug may include a statement to that effect in the application.

  •  (1) A person who wishes to amend an establishment licence shall submit an application to the Minister, in a form established by the Minister, that contains the information and documents referred to in section C.01A.005 that relate to the amendment.

  • (1.1) In addition to the information and documents referred to in subsection (1), a person who submits an application to amend an establishment licence that relates to one or more activities set out in Table I to section C.01A.008 to be carried out in respect of a category of drugs set out in Table II to that section that includes a COVID-19 drug may include a statement to that effect in the application.

  • (2) An establishment licence must be amended where the licensee proposes

    • (a) to add an activity or category of drugs, as set out in the tables to section C.01A.008;

    • (b) in respect of a category of drugs and activity indicated in the licence, to authorize sterile dosage forms of the category;

    • (c) to add any building in Canada at which drugs are authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, or to add, for an existing building, an authorization to fabricate, package/label, test or store a category of drugs, or sterile dosage forms of the category; and

    • (d) in addition to the matters set out in paragraphs (a) to (c), in the case of an importer,

      • (i) to add a fabricator, packager/labeller or tester of a drug,

      • (ii) to amend the name or address of a fabricator, packager/labeller or tester indicated in the licence, and

      • (iii) if the address of the buildings at which drugs are authorized to be fabricated, packaged/labelled or tested is indicated in the licence, to add additional buildings or, for an existing building, to add an authorization to fabricate, package/label or test a category of drugs, or sterile dosage forms of the category.

  •  (1) The Minister may, on receipt of an application for an establishment licence, an amendment to an establishment licence or the review of an establishment licence, require the applicant to submit further details pertaining to the information contained in the application that are necessary to enable the Minister to make a decision.

  • (2) When considering an application, the Minister may require that

    • (a) an inspection be made during normal business hours of any building referred to in paragraph C.01A.005(1)(g) or (h); and

    • (b) the applicant, if a fabricator, a packager/labeller, a person who performs tests required under Division 2, a distributor referred to in paragraph C.01A.003(b) or an importer, supply samples of any material to be used in the fabrication, packaging/labelling or testing of a drug.

Issuance

  •  (1) Subject to subsection (1.1) and section C.01A.010, the Minister shall, on receipt of the information and material referred to in sections C.01A.005 to C.01A.007, issue or amend an establishment licence.

  • (1.1) The Minister shall, in determining whether he or she has received the information and material referred to in sections C.01A.005 to C.01A.007 in relation to an application referred to in subsection C.01A.005(2) or C.01A.006(1.1) that contains the statement referred to in the applicable subsection, also take into consideration the public health need related to COVID-19.

  • (2) The establishment licence shall indicate

    • (a) each activity that is authorized and the category of drugs for which each activity is authorized, as set out in the tables to this section, specifying for each activity and category whether sterile dosage forms are authorized;

    • (b) the address of each building in Canada at which a category of drugs is authorized to be fabricated, packaged/labelled, tested as required under Division 2 or stored, specifying for each building which of those activities and for which category of drugs, and whether sterile dosage forms of the category are authorized; and

    • (c) in addition to the matters referred to in paragraphs (a) and (b), in the case of an importer,

      • (i) the name and address of each fabricator, packager/labeller and tester from whom the importer is authorized to obtain the drug for import, and

      • (ii) the address of each building at which the drug is authorized to be fabricated, packaged/labelled or tested, specifying for each building the activities and the category of drugs that are authorized, and whether sterile dosage forms are authorized.

    • (d) [Repealed, SOR/2002-368, s. 5]

  • (3) The Minister may indicate in an establishment licence a period for which records shall be retained under Division 2 that, based on the safety profile of the drug or materials, is sufficient to ensure the health of the consumer.

  • (4) When issuing an establishment licence, the Minister may impose terms and conditions on the establishment licence respecting

    • (a) the tests to be performed in respect of a drug, and the equipment to be used, to ensure that the drug is not unsafe for use; and

    • (b) any other matters necessary to prevent risk to the health of consumers, including conditions under which drugs are fabricated, packaged/labelled or tested.

    TABLE I

    ItemActivities
    1Fabricate
    2Package/label
    3Perform the tests, including any examinations, required under Division 2
    4Distribute as a distributor referred to in paragraph C.01A.003(a) an active ingredient that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act
    5Distribute as a distributor referred to in paragraph C.01A.003(b)
    6Import
    7Wholesale a drug that is not an active pharmaceutical ingredient or an active ingredient that is used in the fabrication of a drug that is of non-biological origin and that is listed in Schedule C to the Act

    TABLE II

    ItemCategories of drugs
    1Pharmaceuticals
    1.1Active ingredients
    2Vaccines
    3[Repealed, SOR/2013-179, s. 2]
    4Drugs that are listed in Schedule D to the Act, other than vaccines
    5Drugs listed in Schedule C to the Act
    6

    Drugs that are prescription drugs, controlled drugs as defined in section G.01.001, narcotics as defined in the Narcotic Control Regulations and drugs containing cannabis as defined in subsection 2(1) of the Cannabis Act

    7Active pharmaceutical ingredients set out in List A that are for veterinary use
 
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