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Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Version of section 30 from 2007-06-07 to 2007-12-07:


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 1Column 2Column 3Column 4
    From retrieval establishment to transplant establishmentFrom retrieval establishment to cell bankFrom cell bank to any other establishment
    ItemRequired informationInterior labelPackage insertExterior labelInterior labelPackage insertExterior labelInterior labelPackage insertExterior label
    Information about donor and cell
    1Name of cellXXXXXX
    2Description of cellXXX
    3Donor identification code, clearly labelled as suchXXXX
    4Information capable of identifying the donorXX
    5Donor assessment recordX
    6ABO group and Rh factor of donor, if applicableXXXXXX
    7The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicableXXXXXX
    Retrieval information
    8Date, time and time zone of retrievalXX
    9Information specific to retrieval procedureXX
    Processing information
    10Name of anticoagulant and other additive, if applicableXXX
    11Statement “For Autologous Use Only”, if applicableXXXXXX
    Information for transplant establishment
    12Statement that the cell has been declared safe for transplantationX
    13Statement “For Exceptional Distribution”, if applicableXX
    14If applicable, the reasons for exceptional distribution and a statement of how the cell does not meet the requirements of these RegulationsXX
    15Instructions on how to report errors, accidents and adverse reactionsX
    16Expiry date and time, if applicableXX
    Establishment information
    17Name of retrieval establishment, its civic address and contact informationXXXX
    18Name of source establishment, its civic address and contact informationXXXXXX
    19Registration number of source establishment, clearly labelled as suchXXXX
    20Name of transplant establishment, if known, its civic address and contact informationXX
    Storage information
    21Statement “Human cells for transplant”XXX
    22Handling instructions for storage and for storage during transportationXXX
  • 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 1Column 2Column 3
    PANCREAS: From retrieval establishment to source establishmentISLET CELLS: From source establishment to any other establishment
    ItemRequired informationInterior labelPackage insertExterior labelInterior labelPackage insertExterior label
    Information about donor and organ or islet cells
    1Name of organ or cells, as applicableXXXX
    2Description of organ or cells, as applicableXX
    3Donor identification code, clearly labelled as suchXX
    4Information capable of identifying the donorXX
    5Donor assessment recordX
    6ABO group and Rh factor of donor, if applicableXXXX
    7The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicableXXXX
    Retrieval information
    8Date, time and time zone of asystole or aortic clamping, if applicableX
    9Date, time and time zone of retrievalX
    10Information specific to retrieval procedureX
    11Name of perfusion solutionX
    Processing information
    12Name of storage solutionX
    13Name of additives, if applicableX
    Information for establishments
    14Statement that the cells have been declared safe for transplantationX
    15Statement “For Exceptional Distribution”, if applicableXXX
    16If applicable, the reasons for exceptional distribution and a statement of how the organ or cells do not meet the requirements of these RegulationsXX
    17Instructions on how to report errors, accidents and adverse reactionsXX
    18Expiry date and time, if applicableXX
    Establishment information
    19Name of retrieval establishment, its civic address and contact informationXXXX
    20Name of source establishment, its civic address and contact informationXXXX
    21Registration number of source establishment, clearly labelled as suchXXXX
    22Name of other establishment, its civic address and contact informationX
    Storage information
    23Statement “Human organ for transplant” or “Human cells for transplant”, as applicableXX
    24Handling instructions for storage and for storage during transportationXX

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