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Information update

Important information regarding semen donation

Starting date:
December 7, 2010
Posting date:
December 7, 2010
Type of communication:
Information Update
Subcategory:
Biologic/vaccine
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public
Identification number:
RA-110004009

Health Canada is informing Canadians about the potential dangers of using fresh donor semen for assisted conception. Various websites provide a listing of Canadian semen donors available to provide fresh donor semen to Canadian women for assisted conception. It is important to note that the distribution of fresh semen is prohibited by paragraph 5.(b)(ii) of the Processing and Distribution of Semen for Assisted Conception Regulations.

The safety of donor semen intended for assisted conception is paramount. To this end, Semen Regulations set forth requirements that are aimed at minimizing the potential risk of transmitting infectious agents to mother and child. Donor semen for assisted conception must be processed in accordance with the Semen Regulations and quarantined for a minimum of six months. The donor must be screened and tested before and after the donation in order to minimize the risk of transmission of infectious disease.

Under the Food and Drugs Act, donor semen is considered a drug and as such the distribution, processing and importation of donor semen must be conducted as per all applicable sections of the Food and Drugs Act and the Semen Regulations. The Semen Regulations define assisted conception as a reproductive technique performed on a woman for the purpose of conception, using semen from a donor who is not her spouse or sexual partner.

Health Canada has an effective National Inspection Programme that assesses compliance of semen establishments with the Semen Regulations.

Health Canada recommends that Canadians who would like to donate semen or are considering using donor semen for assisted conception consult their health care professionals. In addition, the following website provides a list of Canadian semen processors and importers.


Media enquiries

Health Canada
613-957-2983

Public enquiries

613-957-2991
1-866-225-0709