Blood Regulations (SOR/2013-178)

Marginal note:Non-application — various therapeutic products

• 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;

  • (b) blood that is the subject of clinical trials under Division 5 of Part C of the Food and Drug Regulations; or

  • (c) blood that is imported for use in the manufacture of a drug for human use.

• Marginal note:Non-application — regulations

  (2) Except for section A.01.045 of the Food and Drug Regulations, no other regulation made under the Act applies to blood that is the subject of these Regulations.

• Marginal note:Non-application — imported rare phenotypes

  (3) Sections 4 to 124 do not apply to blood that is of a rare phenotype if it is imported pursuant to a prescription.