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  1. Safety of Human Cells, Tissues and Organs for Transplantation Regulations - SOR/2007-118 (Section 30)
    Marginal note:Cells, except islet cells

    • 30 (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
      4 Information capable of identifying the donor X X

    • (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
      4 Information capable of identifying the donor X X

    [...]


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

    32 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
    4 All information in the donor assessment record that is not capable of identifying the donor X

    [...]


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

    31 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
    4 Information capable of identifying the donor X X

    [...]


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