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

Regulations are current to 2017-11-20 and last amended on 2017-11-13. Previous Versions

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

  • (a) a distributor of an active ingredient or a drug in dosage form that is listed in Schedule C to the Act; 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.

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 a drug as set out in section C.01A.003 that is not an active pharmaceutical ingredient; or

    • (d) wholesale a drug that is not an active pharmaceutical ingredient.

  • (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) in respect of a narcotic as defined in the Narcotic Control Regulations or a controlled drug as defined in subsection G.01.001(1) unless the person holds a licence for that narcotic or drug under the Narcotic Control Regulations or Part G of these Regulations, as the case may be.

  • SOR/97-12, s. 5;
  • SOR/2002-368, s. 3;
  • SOR/2013-74, s. 4.

Application

[SOR/2011-81, s. 1(E)]

 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 or each controlled drug as defined in subsection G.01.001(1) 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.

  • SOR/97-12, s. 5;
  • SOR/2000-120, s. 2;
  • SOR/2002-368, s. 4;
  • SOR/2011-81, s. 2;
  • SOR/2013-74, s. 5.
  •  (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.

  • (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.

  • SOR/97-12, s. 5;
  • SOR/2011-81, s. 3.
  •  (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.

  • SOR/97-12, s. 5;
  • SOR/2011-81, s. 4.
 
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