An Update from Health Canada Re:
Additional Guidance regarding the Sperm and Ova Primary Establishment Registration Application and Establishment Notification form (FRM-0446)
On February 4, 2020, the Safety of Sperm and Ova Regulations (Safety Regulations) came into force. The Safety Regulations apply to donor sperm and ova 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. The Regulations also apply to ova that has been obtained from a donor and that is intended for the donor's use as a surrogate mother. Under the Safety Regulations, primary establishments that conduct all or are responsible for all the processing activities must register with Health Canada, and establishments that import or distribute sperm or ova must notify Health Canada of these activities. For establishments that were processing, importing or distributing sperm or ova prior to the day of the coming into force of the Safety Regulations, as per the transitional provisions in the Safety Regulations, the registration application and/or notification form must be submitted to Health Canada by May 4, 2020.
The Biological Product Compliance Program is in the process of reviewing these registration applications and notifications and has determined that additional clarification and guidance is required regarding the registration and notification requirements as well as the specific requirements within the form (FRM-446). See the attached link to the Sperm and Ova primary establishment registration application and establishment notification form (FRM-0446) as well as to the Guidance Document: Safety of Sperm and Ova Regulations.
In the documents linked below, you will find additional guidance on completing the various sections within the form and what specific information Health Canada requires in order to complete the review of the submitted forms. For establishments who have already submitted the registration application or notification form, please review the below information to determine if your establishment needs to resubmit an updated form.
Click the button below to see the entire communication (with links) from Health Canada. You will need to be logged in to the CFAS Portal to view the documents.