Government of Canada / Gouvernement du Canada
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Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Version of section 32 from 2007-12-08 to 2015-02-10:

Marginal note:Organs

 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.



Column 1Column 2Column 3
DECEASED DONOR: From retrieval establishment to transplant establishmentLIVING DONOR: From retrieval establishment to transplant establishment
ItemRequired informationInterior labelPackage insertExterior labelInterior labelPackage insertExterior label
Information about donor and organ
1Name of organ, and whether left or right side, if applicableXXXXX
2Description of organXX
3Donor identification code, clearly labelled as suchXXXX
4All information in the donor assessment record that is not capable of identifying the donorX
5ABO group and Rh factor of donorXXXX
6The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicableXXXX
Retrieval information
7Date, time and time zone of asystole or aortic clamping, if applicableX
8Date, time and time zone of retrievalXX
9Information specific to retrieval procedureXX
10Name of perfusion solutionXX
Processing information
11Name of storage solutionXX
Information for transplant establishment
12Statement that the organ has been declared safe for transplantationX
13Statement “For Exceptional Distribution”, if applicableXXXX
14If applicable, the reasons for exceptional distribution and a statement of how the organ does not meet the requirements of these RegulationsXX
15Instructions on how to report errors, accidents and adverse reactionsXX
Establishment information
16Name of retrieval establishment, its civic address and contact informationXXXX
17Name of source establishment, its civic address and contact informationXXXX
18Registration number of source establishment, clearly labelled as suchXXXX
19Name of transplant establishment, its civic address and contact informationXX
Storage information
20Statement “Human organ for transplant”XX
21Handling instructions for storage and for storage during transportationXX

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