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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

  •  (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
    1.Swissmedic, 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
    2.Regional 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
    3.Regional 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
    4.Regional 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
    5.Regional 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.