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Request for comments from industry on Draft Risk Classification of Observations to Donor Semen Establishments (GUI-0053)
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Notice to the reader: This online consultation is now closed. The final report is available. The content found on this page is a snapshot of the live consultation as it was presented to the public during the consultation period.
Health Canada is pleased to announce the release of a draft revised guidance document entitled "Risk Classification of Observations to Donor Semen Establishments (GUI-0053)".
This document provides guidelines for classification of the observations noted during the inspections of donor semen establishments based on the risk. This guidance document covers donor semen used for assisted conception regulated under the Food and Drugs Act and the Processing and Distribution of Semen for Assisted Conception Regulations (Semen Regulations). The Appendix attached to the guidance document provides examples of situations or observations related to each category of risk. Please note that the list of situations or observations in the appendix is not exhaustive and that additional situations or observations may be added where appropriate.
Below, please find information on how to provide comments on this document.
How to Get Involved
This consultation is open for comments starting February 5, 2010 until April 19, 2010. In order to read the draft document, please select the link below titled "Consultation Document." Please fill out the "Forms for comments" and submit via email, fax or by mail to:
Blood, Tissues, Organs and Xenografts Unit (BTOX)
Health Products and Food Branch Inspectorate
250 Lanark Avenue
Ottawa, Ontario K1A 0K9
Phone: 613-954-5011
Fax: 613-946-5636
Email: Blood, Tissues, Organs and Xenografts Unit
Comments are requested on the Following Draft Document:
- Risk Classification of Observations to Donor Semen Establishments (GUI-0053)
Comments received from stakeholders and interested parties will be reviewed after the 75
day comment period.
Form for comments
Interested parties are encouraged to provide comments and suggestionsby April 19, 2010 on the above document.
Reporting to Canadians
Health Canada will make the results of this consultation available on this Web site.
If you have any questions, contact us at Blood, Tissues, Organs and Xenografts Unit, Health Products and Food Branch Inspectorate
Yours truly
Original signed by
Diana Dowthwaite
Director General
