Food and Drug Regulations

Version of section C.01A.008 from 2018-06-13 to 2018-10-16:

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

  • (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    • (d) [Repealed, SOR/2002-368, s. 5]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) The Minister may, in addition to the requirements of subsection (2), set out in an establishment licence terms and conditions 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 injury 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
    6Drugs that are prescription drugs, controlled drugs as defined in subsection G.01.001(1) and narcotics as defined in the Narcotic Control Regulations
    7Active pharmaceutical ingredients set out in List A that are for veterinary use
  • SOR/97-12, s. 5;
  • SOR/2000-120, s. 3;
  • SOR/2002-368, s. 5;
  • SOR/2013-74, s. 6;
  • SOR/2013-122, s. 15;
  • SOR/2013-179, s. 2;
  • SOR/2017-76, s. 9;
  • SOR/2017-259, s. 14.
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