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

  •  (1) An importer of a drug that is fabricated, packaged/labelled or tested in an MRA country at a recognized building shall immediately notify the Minister if the fabricator, packager/labeller or tester indicated in the importer’s establishment licence no longer holds a valid permit, licence or other authorization issued by the regulatory authority that recognized that building.

  • (2) The Minister shall, on receiving a notification under subsection (1), amend the importer’s establishment licence by removing the name and address of that fabricator, packager/labeller or tester.

  • SOR/97-12, s. 5;
  • SOR/2000-120, s. 6;
  • SOR/2002-368, s. 7.

Suspension

  •  (1) Subject to subsection (3), the Minister may suspend 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

    • (a) the licensee has contravened any provision of the Act or these Regulations; or

    • (b) the licensee has made a false or misleading statement in the application for the establishment licence.

  • (2) Before suspending an establishment licence, the Minister shall consider

    • (a) the licensee’s history of compliance with the Act and these Regulations; and

    • (b) the risk that allowing the licence to continue in force would constitute for the health of the consumer.

  • (3) Subject to subsection C.01A.017(1), the Minister shall not suspend an establishment licence until

    • (a) an inspector has sent the licensee a written notice that sets out the reason for the proposed suspension, any corrective action required to be taken and the time within which it must be taken;

    • (b) if corrective action is required, the time set out in the notice has passed without the action having been taken; and

    • (c) the licensee has been given an opportunity to be heard in respect of the suspension.

  • SOR/97-12, s. 5.
  •  (1) The Minister may suspend an establishment licence without giving the licensee an opportunity to be heard if it is necessary to do so to prevent injury to the health of the consumer, by giving the licensee a notice in writing that states the reason for the suspension.

  • (2) A licensee may request of the Minister, in writing, that the suspension be reconsidered.

  • (3) The Minister shall, within 45 days after the date of receiving the request, provide the licensee with the opportunity to be heard.

  • SOR/97-12, s. 5.

 The Minister may reinstate an establishment licence after it has been suspended.

  • SOR/97-12, s. 5.

Cancellation

 The Minister shall cancel an establishment licence in either of the following circumstances:

  • (a) the licence has been suspended for a period of more than 12 months, or

  • (b) the licence holder has failed to submit an application for the review of their licence in accordance with subsection C.01A.009(1).

  • SOR/2011-81, s. 6.

Designation

  •  (1) For the purposes of this Division and Divisions 2 to 4, a regulatory authority that is set out in column 1 of the table to this section is hereby designated in respect of the activities set out in column 3 for the drug or category of drugs set out in column 2.

  • (2) Whole blood and its components are excluded from the drugs and categories of drugs set out in column 2 of the table to this section.

  • (3) The lot release of drugs listed in Schedule D to the Act is excluded from the activity of testing set out in column 3 of the table to this section.

    TABLE

    Designated Regulatory Authorities

    ItemColumn 1Column 2Column 3
    Regulatory authorityDrug or category of drugsActivities
    1Swissmedic, Swiss Agency for Therapeutic Products, Bern, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testing
    Drugs listed in Schedules C and D to the Act
    2Regional Medicines Inspectorate of Northwestern Switzerland (RFS-NW), Basel, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testing
    Drugs listed in Schedules C and D to the Act
    3Regional Medicines Inspectorate of Eastern and Central Switzerland (RFS-OZ), Zurich, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testing
    Drugs listed in Schedules C and D to the Act
    4Regional Medicines Inspectorate of Southern Switzerland (RFS-S), Ticino, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testing
    Drugs listed in Schedules C and D to the Act
    5Regional Medicines Inspectorate of Western Switzerland (RFS-W), Lausanne, SwitzerlandPharmaceuticals for human or veterinary useFabricating, packaging/labelling, testing
    Drugs listed in Schedules C and D to the Act
  • SOR/97-12, s. 5;
  • SOR/2000-120, s. 7;
  • SOR/2002-368, s. 8.

DIVISION 2Good Manufacturing Practices

 [Repealed, SOR/97-12, s. 5.1]

 In this Division,

drug

drug[Repealed, SOR/97-12, s. 6]

importer

importer[Repealed, SOR/97-12, s. 6]

medical gas

medical gas means any gas or mixture of gases manufactured, sold or represented for use as a drug; (gaz médical)

packaging material

packaging material includes a label; (matériel d’emballage)

produce

produce[Repealed, SOR/97-12, s. 6]

quality control department

quality control department[Repealed, SOR/2010-95, s. 1]

specifications

specifications means a detailed description of a drug, the raw material used in a drug or the packaging material for a drug and includes

  • (a) a statement of all properties and qualities of the drug, raw material or packaging material that are relevant to the manufacture, packaging and use of the drug, including the identity, potency and purity of the drug, raw material or packaging material,

  • (b) a detailed description of the methods used for testing and examining the drug, raw material or packaging material, and

  • (c) a statement of tolerances for the properties and qualities of the drug, raw material or packaging material. (spécifications)

  • SOR/82-524, s. 3;
  • SOR/85-754, s. 1;
  • SOR/89-174, s. 1;
  • SOR/97-12, s. 6;
  • SOR/2010-95, s. 1.
 
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