The information on this page will change as a result of the new Safety of Sperm and Ova Regulations under the Assisted Human Reproduction Act coming into force in February 2020. For more information visit the Assisted Human Reproduction web page.
The Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations) require the following notifications to Health Canada:
- from importers and processors, at least 10 days before they start importing or processing activities in Canada
- if the processor is conducting an investigation into a suspected contamination of the semen by an infectious agent, within 3 days of the start of that investigation
In Canada, donor semen for assisted conception is classified as a drug. It is regulated under the Food and Drugs Act and the Semen Regulations.
The aim of the Semen Regulations is to prevent the spread of infectious disease to people who receive donor semen and to their offspring.
On this page
Who is required to notify us
Anyone who imports or processes donor semen in Canada is subject to some notification requirements under the Semen Regulations.
Where to send notices
All notices or information can be sent to be Health Canada by:
- Email: firstname.lastname@example.org
- Fax: 613-960-2156
Health Canada is authorized to inspect semen establishments under section 23 of the Food and Drugs Act.
Inspections are an important part of the national compliance and enforcement program for donor semen.
This program applies to all known Canadian semen establishments that process, import and/or distribute donor semen used in assisted conception.
For more information on the inspection program please consult the Inspection Strategy for Semen Establishments (POL-0023).
- Guidance on the Processing and Distribution of Semen for Assisted Conception Regulations (GUI-0041)
- Guidance Document Interim Compliance Approach Regarding the Testing of Semen Donors for Treponema pallidum (Syphilis)
- Guidance on Donor Semen Special Access Programme: Alternative Test Requirements
- Guidance on Donor Semen Special Access Programme: Donor Semen Eligible for Special Access
- Risk Classification of Observations to Donor Semen Establishments (GUI-0053)
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