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Marginal note:Six months after registration

• Footnote ^*79 (1) These Regulations, except subsection 26(1), come into force six months after the day on which they are registered.

• Marginal note:Exception

  (2) Subsection 26(1) comes into force one year after the day on which these Regulations are registered.

• Marginal note:Transitional provision

  (3) Section 78 ceases to be in force five years after the day on which these Regulations are registered.

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Marginal note:Non-application — various therapeutic products

• 3 (1) These Regulations do not apply to any of the following therapeutic products:

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• Marginal note:Non-application — regulations

  (2) No other regulation made under the Act applies to cells, tissues or organs that are the subject of these Regulations.

Marginal note:Non-application — various therapeutic products

• 3 (1) These Regulations do not apply to any of the following therapeutic products:

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• Marginal note:Non-application — regulations

  (2) No other regulation made under the Act applies to cells, tissues or organs that are the subject of these Regulations.

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Marginal note:Scope of Regulations

2 These Regulations apply only to organs and minimally manipulated cells and tissues.

Marginal note: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.

  	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
  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

• (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.

  	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
  16	If applicable, the reasons for exceptional distribution and a statement of how the organ or cells do not meet the requirements of these Regulations		X			X

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