Food and Drug Regulations

Version of section C.04.415 from 2006-12-14 to 2014-10-22:


 A fabricator shall place source plasma in a container

  • (a) in respect of which a medical device licence has been issued under the Medical Devices Regulations for the purpose of collecting and storing plasma;

  • (b) that permits visual, electronic or automated inspection of the plasma;

  • (c) that has been visually inspected at the plasmapheresis session and found to be intact; and

  • (d) that has not been previously used for any purpose, including holding source plasma from the same donor.

  •  SOR/78-545, s. 1;
  • SOR/85-1022, s. 6;
  • SOR/2006-353, s. 1.
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