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

Regulations are current to 2021-05-19 and last amended on 2021-04-14. Previous Versions

PART CDrugs (continued)

DIVISION 1AEstablishment Licences (continued)

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 [Repealed, SOR/97-12, s. 5.1]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drug[Repealed, SOR/97-12, s. 6]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importer[Repealed, SOR/97-12, s. 6]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

 This Division does not apply to fabricating, packaging/labelling, testing, storing and importing of antimicrobial agents.

  • SOR/2004-282, s. 3

Sale

 No distributor referred to in paragraph C.01A.003(b) and no importer shall sell a drug unless it has been fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.

  • SOR/82-524, s. 3
  • SOR/97-12, s. 7
  • SOR/2000-120, s. 8
  • SOR/2010-95, s. 2(F)

 No person shall sell a drug that they have fabricated, packaged/labelled, tested or stored unless they have fabricated, packaged/labelled, tested or stored it in accordance with the requirements of this Division.

  • SOR/2013-74, s. 7
  •  (1) No person shall import an active ingredient into Canada for the purpose of sale unless they have in Canada a person who is responsible for its sale.

  • (2) No person who imports an active ingredient into Canada shall sell any lot or batch of it unless the following appear on its label:

    • (a) the name and civic address of the person who imports it; and

    • (b) the name and address of the principal place of business in Canada of the person who is responsible for its sale.

  • SOR/2013-74, s. 7

Use in Fabrication

 No person shall use an active ingredient in the fabrication of a drug unless it is fabricated, packaged/labelled, tested and stored in accordance with the requirements of this Division.

  • SOR/2013-74, s. 7

Premises

 The premises in which a lot or batch of a drug is fabricated, packaged/labelled or stored shall be designed, constructed and maintained in a manner that

  • (a) permits the operations therein to be performed under clean, sanitary and orderly conditions;

  • (b) permits the effective cleaning of all surfaces therein; and

  • (c) prevents the contamination of the drug and the addition of extraneous material to the drug.

  • SOR/82-524, s. 3
  • SOR/97-12, s. 8
  • SOR/2010-95, s. 3

Equipment

 The equipment with which a lot or batch of a drug is fabricated, packaged/labelled or tested shall be designed, constructed, maintained, operated and arranged in a manner that

  • (a) permits the effective cleaning of its surfaces;

  • (b) prevents the contamination of the drug and the addition of extraneous material to the drug; and

  • (c) permits it to function in accordance with its intended use.

  • SOR/82-524, s. 3
  • SOR/97-12, s. 9

Personnel

 Every lot or batch of a drug shall be fabricated, packaged/labelled, tested and stored under the supervision of personnel who, having regard to the duties and responsibilities involved, have had such technical, academic and other training as the Minister considers satisfactory in the interests of the health of the consumer or purchaser.

  • SOR/82-524, s. 3
  • SOR/85-754, s. 2
  • SOR/97-12, s. 52
  • SOR/2018-69, s. 27

Sanitation

  •  (1) Every person who fabricates or packages/labels a drug shall have a written sanitation program that shall be implemented under the supervision of qualified personnel.

  • (2) The sanitation program referred to in subsection (1) shall include

    • (a) cleaning procedures for the premises where the drug is fabricated or packaged/labelled and for the equipment used in the fabrication or packaging/labelling; and

    • (b) instructions on the sanitary fabrication and packaging/labelling of drugs and the handling of materials used in the fabrication and packaging/labelling of drugs.

  • SOR/82-524, s. 3
  • SOR/97-12, ss. 10, 53
 
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