Donating and using third-party sperm or ova (eggs) for assisted human reproduction

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Donor sperm and ova (eggs)

Donor sperm and ova (eggs) are sperm and ova that are intended for use in assisted human reproduction (AHR) by a recipient who is not the spouse, common-law partner or sexual partner of the donor.

This includes:

Donor screening and testing

In Canada, all donor sperm and ova (egg) must meet safety standards before they can be used for AHR.

All donors must undergo a suitability assessment to identify any risk factors for infectious and genetic disease transmission, which could impact the safety of the sperm and ova.

The donor suitability assessment involves:

The Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors contains more information and a full list of testing and screening requirements.

Regulating third party sperm and ova (eggs)

The Safety of Sperm and Ova Regulations apply to establishments and health professionals who process, import, distribute or make use of donor sperm or ova for the purpose of AHR. 

All establishments and health professionals that process, import, distribute or make use of donor sperm and ova (eggs) for the purpose of AHR must:

Primary establishments:

Establishments that import or distribute must notify Health Canada. 

Both primary establishments and establishments that only import or distribute must submit an attestation of compliance every year.

Compliance monitoring activities in Canada

Health Canada carries out compliance monitoring activities, including inspections of regulated parties to:

When Health Canada identifies a problem, it takes action in line with the level of risk to public health and safety. Actions may include:

Information on all inspections conducted under the Safety of Sperm and Ova Regulations are published in the Drug and Health Product Inspections Database.

If you have questions about how donor sperm and ova (eggs) are regulated, contact Health Canada's Biologics and Genetic Therapies Directorate at hc.bgtd.opic-bpci.dpbtg.sc@canada.ca.

If you have questions about compliance and enforcement, contact the Biological Product Compliance Program at hc.bpcp-pcpb.sc@canada.ca.

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