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Safety of Human Cells, Tissues and Organs for Transplantation Regulations

Version of section 31 from 2007-06-07 to 2007-12-07:

Marginal note:Tissues

31 An establishment that distributes tissues 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 31

LABELLING REQUIREMENTS FOR TISSUE

Item	Required information	Interior label	Package insert	Exterior label	Interior label	Package insert	Exterior label
	Column 1	Column 2			Column 3
		From retrieval establishment to tissue bank			From tissue bank to any other establishment
Information about donor and tissue
1	Name of tissue, and whether left or right side, if applicable	X	X		X	X
2	Description of tissue		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	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
7	Date, time and time zone of asystole or aortic clamping, if applicable		X
8	Date, time and time zone of retrieval		X
9	Information specific to retrieval procedure		X
Processing information
10	Name of storage solution, if applicable		X			X
11	Name of anticoagulant and other additive, if applicable					X
12	Statement that the tissue has been irradiated, if applicable				X	X
13	Description of the disinfection and sterilization processes that were used, if applicable					X
14	Statement “For Autologous Use Only”, if applicable	X	X		X	X
Information for transplant establishment
15	Tissue-specific instructions for preparation for use, if applicable					X
16	Statement that the tissue has been declared safe for transplantation					X
17	Statement “For Exceptional Distribution”, if applicable				X	X
18	If applicable, the reasons for exceptional distribution and a statement of how the tissue does not meet the requirements of these Regulations					X
19	Instructions on how to report errors, accidents and adverse reactions					X
20	Expiry date and time, if applicable				X	X
Establishment information
21	Name of retrieval establishment, its civic address and contact information		X	X
22	Name of source establishment, its civic address and contact information		X	X		X	X
23	Registration number of source establishment, clearly labelled as such					X	X
24	Name of transplant establishment, if known, its civic address and contact information						X
Storage information
25	Statement “Human tissue for transplant”			X			X
26	Handling instructions for storage and for storage during transportation			X			X

Date modified:: 2024-11-13

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Safety of Human Cells, Tissues and Organs for Transplantation Regulations