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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
    •  (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
      21 Statement “Human cells for transplant” X 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
      23 Statement “Human organ for transplant” or “Human cells for transplant”, as applicable X X

    [...]


  2. Blood Regulations - SOR/2013-178 (Section 3)
    Marginal note:Non-application — various therapeutic products

  3. Safety of Sperm and Ova Regulations - SOR/2019-192
  4. Safety of Sperm and Ova Regulations - SOR/2019-192 (Section 92)
  5. Hazardous Products Regulations - SOR/2015-17

    Safety of Human Cells, Tissues and Organs for Transplantation Regulations



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