Compliance and Enforcement: Assisted Human Reproduction
The Regulatory Operations and Enforcement Branch of Health Canada is responsible for compliance and enforcement activities related to the Assisted Human Reproduction Act (the AHR Act) and its Regulations.
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The AHR Act and its Regulations
The AHR Act
The AHR Act and its Regulations establish the framework to help protect the health, safety, dignity and rights of individuals who use or are born of assisted human reproduction in Canada.
Safety of Sperm and Ova Regulations (Safety Regulations)
The Safety Regulations focus on reducing risks to human health and safety arising from the use of sperm or ova (eggs) for the purpose of AHR in Canada. The Safety Regulations include a set of requirements for the processing, importing, distributing or making use of donor sperm or ova (eggs) for the purpose of AHR, including measures related to the traceability of such sperm or ova (eggs).
The Safety Regulations set out a number of requirements that regulated parties must comply with, in relation to:
- donor suitability assessment
- tracing and identifying
- labelling and storage
- quality management
- personnel, facilities, equipment and supplies
- errors and accidents
- adverse reactions, and
Registering with Health Canada
Primary establishments must register with Health Canada and are responsible for all of the processing activities with respect to sperm or ova for use in AHR, whether they conduct the activity themselves or another establishment is conducting the activity on their behalf.
Notifying Health Canada
Establishments that import or distribute donor sperm or ova for the purpose of AHR are required to notify Health Canada prior to importing or distributing activities.
The registration and notification application form for sperm and ova establishments is available in the Forms section.
Both primary establishments and establishments that only import or distribute must also submit an annual attestation of compliance by April 1 of each year.
Reporting Errors or Accidents
Establishments and health professionals that conduct an activity subject to the Safety Regulations are required to investigate and report their own errors and accidents to Health Canada and keep records, in accordance with the Safety Regulations.
The error and accident investigation reporting form is available in the Forms section.
Reimbursement Related to Assisted Human Reproduction Regulations (Reimbursement Regulations)
The Reimbursement Regulations set categories of allowable expenditures that may be reimbursed in relation to the donation of sperm and ova, the maintenance and transport of IVEs, and surrogacy, as well as set out requirements for the reimbursement of loss of work-related income for surrogate mothers.
Administration and Enforcement (Assisted Human Reproduction Act) Regulations
The Administration and Enforcement (Assisted Human Reproduction Act) Regulations set out a framework for enforcement. These set out activities that inspectors designated under the AHR Act by the Minister of Health may undertake to verify compliance with sections 8, 10 and 12 of the AHR Act, or to prevent non-compliance.
Assisted Human Reproduction (Section 8 Consent) Regulations
The Assisted Human Reproduction (Section 8 Consent) Regulations set out, among other things, the requirements in relation to the required donor consent for the use of human reproductive material, as required by section 8 of the AHR Act. These include provisions which help protect donor anonymity and related requirements such as record keeping and retention.
Guides and Policies
The Regulatory Operations and Enforcement Branch of Health Canada is responsible for the compliance and enforcement approach for materials and activities subject to the AHR Act and its Regulations. The compliance and enforcement approach includes compliance promotion, proactive compliance monitoring including inspections and responsive enforcement actions.
- Guidance Document: Interim Compliance Approach Regarding Donor Ova Processed Prior to February 4, 2020
- Compliance and Enforcement Policy for the Assisted Human Reproduction Act (POL-0100)
- Inspection Approach for the Safety of Sperm and Ova Regulations (POL-0125)
- Compliance Approach for the Reimbursement Related to Assisted Human Reproduction Regulations (POL-0124)
- Risk Classification Guide for Observations related to the Safety of Sperm and Ova (GUI-0129)
- Registration and notification guide for donor sperm and ova establishments (GUI-0128)
Registration and Notification
- FRM-0446: Sperm and ova primary establishment registration application
- FRM-0448: Sperm and ova establishment notification form
- FRM-0449: Sperm and ova establishment annual attestation form
Errors or Accidents
- Reporting a complaint for materials and activities subject to the Assisted Human Reproduction Act.
- Donating and using third-party sperm or ova (eggs) for assisted human reproduction
- Reimbursing a sperm or ova (eggs) donor or a surrogate for expenditures related to donation or surrogacy
If you have a question about Health Canada's compliance and enforcement approach, contact the Biological Product Compliance Program:
Biological Product Compliance Program
Regulatory Operations and Enforcement Branch
200 Eglantine Driveway
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