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  1. Safety of Human Cells, Tissues and Organs for Transplantation Regulations - SOR/2007-118 (Section 30)
    Safety of Human Cells, Tissues and Organs for Transplantation Regulations
    Marginal note:Cells, except islet cells
    •  (1) An establishment that distributes cells, except islet cells, must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this subsection is provided on the interior label, in the package insert and on the exterior label.

      TABLE TO SUBSECTION 30(1)

      Labelling Requirements for Cells, Except Islet Cells

      Column 1 Column 2 Column 3 Column 4
      From retrieval establishment to transplant establishment From retrieval establishment to cell bank From cell bank to any other establishment
      Item Required information Interior label Package insert Exterior label Interior label Package insert Exterior label Interior label Package insert Exterior label
      3 Donor identification code, clearly labelled as such X X X X
      19 Registration number of source establishment, clearly labelled as such X X X X
    • Marginal note:Pancreas and islet cells

      (2) An establishment that distributes a pancreas for islet cell transplantation, or islet cells, must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this subsection is provided on the interior label, in the package insert and on the exterior label.

      TABLE TO SUBSECTION 30(2)

      Labelling Requirements for Pancreas and Islet Cells

      Column 1 Column 2 Column 3
      PANCREAS: From retrieval establishment to source establishment ISLET CELLS: From source establishment to any other establishment
      Item Required information Interior label Package insert Exterior label Interior label Package insert Exterior label
      1 Name of organ or cells, as applicable X X X X
      2 Description of organ or cells, as applicable X X
      3 Donor identification code, clearly labelled as such X X
      21 Registration number of source establishment, clearly labelled as such X X X X
      23 Statement “Human organ for transplant” or “Human cells for transplant”, as applicable X X

    [...]


  2. Safety of Human Cells, Tissues and Organs for Transplantation Regulations - SOR/2007-118 (Section 1)
    Safety of Human Cells, Tissues and Organs for Transplantation Regulations

     The following definitions apply in these Regulations.

    general standard

    general standard  means National Standard of Canada CAN/CSA-Z900.1 entitled Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements, as amended from time to time. (norme générale)

    lymphohematopoietic standard

    lymphohematopoietic standard  means National Standard of Canada CAN/CSA-Z900.2.5 entitled Lymphohematopoietic Cells for Transplantation, as amended from time to time. (norme sur les cellules lymphohématopoïétiques)

    medical director

    medical director , in respect of an establishment, means a physician or dentist who is licensed under the laws of the jurisdiction in which the establishment is situated to provide health care or dental care and who is responsible for the application of the standard operating procedures and for all medical or dental procedures carried out there, as the case may be. (directeur médical)

    ocular standard

    ocular standard  means National Standard of Canada CAN/CSA-Z900.2.4 entitled Ocular Tissues for Transplantation, as amended from time to time. (norme sur les tissus oculaires)

    organ standard

    organ standard  means National Standard of Canada CAN/CSA-Z900.2.3 entitled Perfusable Organs for Transplantation, as amended from time to time. (norme sur les organes)

    tissue standard

    tissue standard  means National Standard of Canada CAN/CSA-Z900.2.2 entitled Tissues for Transplantation, as amended from time to time. (norme sur les tissus)


  3. Safety of Human Cells, Tissues and Organs for Transplantation Regulations - SOR/2007-118 (Section 47)
    Safety of Human Cells, Tissues and Organs for Transplantation Regulations
    Marginal note:Required action
    •  (1) Subject to subsection (2), an establishment that is not a source establishment and that has reasonable grounds to believe that an unexpected adverse reaction has occurred must immediately take all of the following steps:

      • [...]

      • (b) identify and quarantine any other cells, tissues and organs in its possession that could potentially cause an adverse reaction in the same way as the transplanted cells, tissues or organs; and

    • [...]

    • Marginal note:Written notice

      (4) If the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.


  4. Safety of Human Cells, Tissues and Organs for Transplantation Regulations - SOR/2007-118 (Section 32)
    Safety of Human Cells, Tissues and Organs for Transplantation Regulations
    Marginal note:Organs

     An establishment that distributes organs must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this section is provided on the interior label, in the package insert and on the exterior label.

    TABLE TO SECTION 32

    Labelling Requirements for Organs

    Column 1 Column 2 Column 3
    DECEASED DONOR: From retrieval establishment to transplant establishment LIVING DONOR: From retrieval establishment to transplant establishment
    Item Required information Interior label Package insert Exterior label Interior label Package insert Exterior label
    3 Donor identification code, clearly labelled as such X X X X
    18 Registration number of source establishment, clearly labelled as such X X X X

    [...]


  5. Safety of Human Cells, Tissues and Organs for Transplantation Regulations - SOR/2007-118 (Section 31)
    Safety of Human Cells, Tissues and Organs for Transplantation Regulations
    Marginal note:Tissues

     An establishment that distributes tissues must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this section is provided on the interior label, in the package insert and on the exterior label.

    TABLE TO SECTION 31

    Labelling Requirements for Tissue

    Column 1 Column 2 Column 3
    From retrieval establishment to tissue bank From tissue bank to any other establishment
    Item Required information Interior label Package insert Exterior label Interior label Package insert Exterior label
    3 Donor identification code, clearly labelled as such X X
    23 Registration number of source establishment, clearly labelled as such X X

    [...]



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