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Canada proposed regulations entitled Safety of Sperm and Ova Regulations

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Canada proposed regulations entitled Safety of Sperm and Ova Regulations

Department of Health proposed Safety of Sperm and Ova Regulationswould establish a human health and safety framework for donor sperm and ova for assisted human reproduction. Specifically, the  proposed regulations would:

  • Establish minimum requirements for screening and testing sperm and ova donors;
  • Establish a risk-based registration and notification oversight scheme for establishments who process, import and distribute donor sperm and ova;
  • Establish a traceability system whereby donor sperm and ova are identified, labelled and stored so that appropriate steps may be taken in the event of an error, accident or adverse reaction; and

Establish a quality management system to ensure that establishments who conduct their activities do so in a manner that prevents contamination or cross-contamination, prevents the transmission of an infectious disease and maintains the quality of the sperm and ova.

Products covered: Sperm and ova for assisted human reproduction

HS code: 300290

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: 10-01-2019

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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