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
(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
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1 The following definitions apply in these Regulations.
tissue means a functional group of human cells for use in transplantation. It includes the cells and tissues listed in the definition tissue in section 3.1 of the general standard, except for paragraphs (g) and (l). (tissu)
3 (1) These Regulations do not apply to any of the following therapeutic products:
(a) cord blood and peripheral blood that are for use in lymphohematopoietic cell transplantation and that are regulated under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations;
Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30Footnote a of the Food and Drugs Act, hereby makes the annexed Safety of Human Cells, Tissues and Organs for Transplantation Regulations.
