Safety of Human Cells, Tissues and Organs for Transplantation Regulations

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.

  	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
  Information about donor and cell
  1	Name of cell	X	X		X	X		X	X
  2	Description of cell		X			X			X
  3	Donor identification code, clearly labelled as such	X	X					X	X
  4	Information capable of identifying the donor				X	X
  5	Donor assessment record					X
  6	ABO group and Rh factor of donor, if applicable	X	X		X	X		X	X
  7	The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicable	X		X	X		X	X		X
  Retrieval information
  8	Date, time and time zone of retrieval		X			X
  9	Information specific to retrieval procedure		X			X
  Processing information
  10	Name of anticoagulant and other additive, if applicable		X			X			X
  11	Statement “For Autologous Use Only”, if applicable	X	X		X	X		X	X
  Information for transplant establishment
  12	Statement that the cell has been declared safe for transplantation								X
  13	Statement “For Exceptional Distribution”, if applicable		X						X
  14	If applicable, the reasons for exceptional distribution and a statement of how the cell does not meet the requirements of these Regulations		X						X
  15	Instructions on how to report errors, accidents and adverse reactions								X
  16	Expiry date and time, if applicable							X	X
  Establishment information
  17	Name of retrieval establishment, its civic address and contact information		X	X		X	X
  18	Name of source establishment, its civic address and contact information		X	X		X	X		X	X
  19	Registration number of source establishment, clearly labelled as such		X	X					X	X
  20	Name of transplant establishment, if known, its civic address and contact information			X						X
  Storage information
  21	Statement “Human cells for transplant”			X			X			X
  22	Handling instructions for storage and for storage during transportation			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.

  	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
  Information about donor and organ or islet cells
  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
  4	Information capable of identifying the donor	X	X
  5	Donor assessment record		X
  6	ABO group and Rh factor of donor, if applicable	X	X		X	X
  7	The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicable	X		X	X		X
  Retrieval information
  8	Date, time and time zone of asystole or aortic clamping, if applicable		X
  9	Date, time and time zone of retrieval		X
  10	Information specific to retrieval procedure		X
  11	Name of perfusion solution		X
  Processing information
  12	Name of storage solution		X
  13	Name of additives, if applicable					X
  Information for establishments
  14	Statement that the cells have been declared safe for transplantation					X
  15	Statement “For Exceptional Distribution”, if applicable		X		X	X
  16	If applicable, the reasons for exceptional distribution and a statement of how the organ or cells do not meet the requirements of these Regulations		X			X
  17	Instructions on how to report errors, accidents and adverse reactions		X			X
  18	Expiry date and time, if applicable				X	X
  Establishment information
  19	Name of retrieval establishment, its civic address and contact information		X	X		X	X
  20	Name of source establishment, its civic address and contact information		X	X		X	X
  21	Registration number of source establishment, clearly labelled as such		X	X		X	X
  22	Name of other establishment, its civic address and contact information						X
  Storage information
  23	Statement “Human organ for transplant” or “Human cells for transplant”, as applicable			X			X
  24	Handling instructions for storage and for storage during transportation			X			X