Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118)

Regulations are current to 2022-11-16 and last amended on 2022-09-27. Previous Versions

Processing (continued)

Packaging and Labelling (continued)

Labelling (continued)

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.

TABLE TO SECTION 32

Labelling Requirements for Organs

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 pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous 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
  • SOR/2015-17, s. 18

Marginal note:Additional information required

 A registered establishment that imports and distributes, or that only distributes, a cell or tissue must ensure that the following information is added to that required by sections 30 and 31:

  • (a) on the exterior label and in the package insert, the name of the establishment, its civic address and contact information; and

  • (b) on the exterior label and in the package insert, the establishment’s registration number.

Quarantine

Marginal note:Quarantine — cells and tissues

  •  (1) A source establishment must ensure that cells, except islet cells, and tissues are quarantined until all of the following processing activities are completed:

    • (a) the donor is found to be suitable after completion of the donor suitability assessment;

    • (b) except in the case of fresh skin, bacteriological test results are reviewed and found to be acceptable, if applicable; and

    • (c) all processing records are reviewed for completeness and compliance with the standard operating procedures.

  • Marginal note:Additional requirement — live donors of tissue

    (2) In addition to the requirements set out in subsection (1), the source establishment must quarantine tissues that are retrieved from live donors in accordance with section 17.2 of the tissue standard.

Storage

Marginal note:Storage limits

 An establishment that distributes cells, tissues or organs and that stores cells, tissues and adjunct vessels that were not used at the time of transplantation of the organ with which they were retrieved must observe scientifically based maximum storage periods.

Marginal note:Storage location

 An establishment that distributes cells, tissues or organs must store them in a location that has appropriate environmental conditions that maintain their safety and that is secure against the entry of unauthorized persons.

Marginal note:Storage during transportation

 An establishment that ships cells, tissues or organs must ensure that they are stored during transportation in appropriate environmental conditions and adequate packaging materials.

 
Date modified: