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

Issuance

  •  (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    • (d) [Repealed, SOR/2002-368, s. 5]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 set out in paragraph C.01A.003(a) a drug that is not an active pharmaceutical ingredient
    5Distribute as set out in paragraph C.01A.003(b)
    6Import
    7Wholesale a drug that is not an active pharmaceutical ingredient

    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
  • 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.

Annual Licence Review

  •  (1) The holder of an establishment licence that is not suspended shall submit an application for the review of their licence to the Minister before April 1 of each year and include with it the information and documents referrred to in section C.01A.005.

  • (2) The Minister shall conduct an annual review of the licence on the basis of the information and documents submitted by the holder and any other relevant information in the Minister’s possession.

  • SOR/97-12, s. 5;
  • SOR/97-298, s. 1;
  • SOR/2011-81, s. 5.

Refusal to Issue

  •  (1) The Minister may refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if

    • (a) the applicant has made a false or misleading statement in relation to the application for the licence; or

    • (b) the applicant has had an establishment licence suspended in respect of the matter.

  • (2) The Minister shall refuse to issue or amend an establishment licence in respect of any or all matters indicated in subsection C.01A.008(2) if the Minister has reasonable grounds to believe that issuing or amending an establishment licence in respect of the matter would constitute a risk to the health of the consumer.

  • (3) Where the Minister refuses to issue or amend an establishment licence, the Minister shall

    • (a) notify the applicant in writing of the reasons for the refusal; and

    • (b) give the applicant an opportunity to be heard.

  • SOR/97-12, s. 5.

Terms and Conditions

  •  (1) Every person who holds an establishment licence shall comply with

    • (a) the requirements and the terms and conditions of the establishment licence; and

    • (b) the applicable requirements of Divisions 2 to 4.

  • (2) [Repealed, SOR/2000-120, s. 4]

  • SOR/97-12, s. 5;
  • SOR/2000-120, s. 4.
  •  (1) The Minister may amend the terms and conditions of an establishment licence if the Minister believes on reasonable grounds that an amendment is necessary to prevent injury to the health of the consumer.

  • (2) The Minister shall give at least 15 days notice in writing to the holder of the establishment licence of the proposed amendment, the reasons for the amendment and its effective date.

  • SOR/97-12, s. 5.

Notification

 Every person who holds an establishment licence shall notify the Minister in writing within 15 days after

  • (a) there is any change to the information referred to in any of paragraphs C.01A.005(a), (b), and (e) to (i); or

  • (b) an event occurs that results in their being in contravention of any of the applicable requirements of Divisions 2 to 4, where it may affect the quality, safety or efficacy of a drug fabricated, packaged/labelled, tested as required under Division 2 or stored by them.

  • SOR/97-12, s. 5;
  • SOR/2017-18, s. 15.
  •  (1) No licensee shall carry on a licensed activity in respect of any category of drugs if a change referred to in subsection (2) has occurred in respect of that category, unless

    • (a) they have filed with the Minister a notice that contains sufficient information to enable the Minister to assess the safety of the drug, taking into account the change; and

    • (b) the Minister has issued to them a letter indicating that the information will be reviewed and has not, within 90 days after issuing the letter, sent them a notice indicating that the change is not acceptable.

  • (2) Notification is required in respect of the following changes where they may affect whether a drug can be fabricated, packaged/labelled, tested or stored in accordance with the applicable requirements of Divisions 2 to 4:

    • (a) changes to the plans and specifications of a building where a drug is fabricated, packaged/labelled, tested or stored;

    • (b) changes to the equipment that is used in the fabrication, packaging/labelling or testing of a drug;

    • (c) changes to the practices or procedures; and

    • (d) in the case of an importer, other than an importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building, any change referred to in paragraphs (a) to (c) that relates to the fabricator, packager/labeller or tester of the drug being imported.

  • SOR/97-12, s. 5;
  • SOR/2000-120, s. 5;
  • SOR/2002-368, s. 6.
 
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