Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 30
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 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 pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous 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 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 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 pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous 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 Distribu