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Registration and notification guide for donor sperm and ova establishments (GUI-0128)

Date issued: 2022
Date implemented: 2022
Replaces: N/A

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Overview

This document provides guidance related to the registration and notification requirements under the Safety of Sperm and Ova Regulations (Safety Regulations) which are made under the authority of the Assisted Human Reproduction Act (AHR Act).

The Safety Regulations:

The Safety Regulations apply to donor sperm and ova intended for use in AHR by a recipient who is not the spouse, common-law partner or sexual partner of the donor, including donor sperm and ova intended for use in AHR techniques (for example, in vitro fertilization). The Safety Regulations also apply to ova that have been obtained from a donor and that are meant for the donor's use as a surrogate mother.

The Safety Regulations do not apply to sperm and ova from a spouse, common-law partner or sexual partner of the recipient.

This guide applies to:

There are 2 types of icons used in this document:

Important: Key or cautionary information for people to know

Information: Supplementary information like quotes and legal references

Guidance

Registration

Primary establishments must register with Health Canada

Under the Safety Regulations, primary establishments:

These lists include examples of establishments required to be either registered as a primary establishment, or listed on a primary establishment's registration.

Registered as a primary establishment (see glossary for more information)

There may be cases where the sperm or ova were obtained prior to the Safety Regulations coming into force and the primary establishment that originally processed the sperm or ova is unwilling or unable to register (for example, in the case of a business closure). Under the Safety Regulations, there must be a primary establishment responsible for all processing activities of sperm or ova that is registered under the Safety Regulations. Therefore, in the event that the primary establishment that originally processed the sperm or ova is not registered under the Safety Regulations, another establishment or health professional could assume the responsibility and register as a primary establishment in order for the sperm or ova to be imported, distributed or used.

Listed on a primary establishment's registration

Foreign establishments that process sperm or ova may:

  • register with Health Canada as a primary establishment to allow the distribution of sperm and ova that they process in Canada, or
  • be listed on the registration of a primary establishment as an establishment that is conducting processing activities on behalf of the primary establishment

Donor screening, including infectious disease screening and genetic disease screening as part of the donor suitability assessment, is a regulated activity under the Safety Regulations. As per Clause 2.1.2 III of the Health Canada Directive: Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors, in lieu of performing genetic disease screening, results of relevant genetic disease testing of the sperm or ova donor that meet the requirement of Clause 2.3.1 II for the presence of specific genetic diseases can be used to assess the donor for risk of genetic disease transmission. Establishments conducting genetic disease testing on behalf of a primary establishment aren't required to be listed on a primary establishment's registration.

It's important to note that genetic disease testing of donors isn't required under the Safety Regulations and thus isn't considered a processing activity under the Safety Regulations. Therefore, the establishment(s) performing the genetic disease testing doesn't need to be listed on the primary establishment's registration if genetic disease testing is performed in lieu of genetic disease screening to assess the donor for risk of genetic disease transmission. The medical director (or qualified professional designated by the medical director) of the primary establishment must assess the donor for the risk of genetic disease transmission. This assessment is based on the donor's genetic disease screening, or the results of their genetic testing in lieu of screening, or both.

Further information on genetic disease testing in lieu of genetic disease screening may be found in the Guidance Document - Safety of Sperm and Ova Regulations.

Registration information that must be sent to Health Canada

The Safety Regulations outline specific requirements of the registration application. The applicant must provide the information set out in subsection 5(1) under the Safety Regulations to Health Canada in the established form. Health Canada developed the Sperm and ova primary establishment registration application (FRM-0446) referred to in this document as the "registration form," to facilitate and streamline the submission of the information required by section 5 of the Safety Regulations.

Once submitted, Health Canada will determine whether to issue a registration number based on the completeness of the information in the registration form. The registration form, along with instructions, is available at Compliance and Enforcement: Assisted Human Reproduction.

In addition to the information required under subsection 5(1), the application must:

It's the applicant's responsibility to ensure that the information provided in the registration form is accurate and complete, in accordance with the requirements of section 5 of the Safety Regulations before filing it with Health Canada. It's the regulated party's responsibility to ensure that their business structure allows them to meet the requirements of the Safety Regulations.

Submission of complete applications will help prevent delays in processing the forms.

Registration application process

Submission of registration application

A primary establishment that processes sperm or ova must be registered by submitting a completed application, using the registration form, to Health Canada.

Review of application by Health Canada

Upon receipt of an application, Health Canada will assess the information to verify its completeness.

During the review, Health Canada may require clarification or additional information to complete the review. If the applicant receives a written request for additional documents and information from Health Canada, the applicant must provide the requested information per subsection 5(3) of the Safety Regulations. In some cases, this may result in an updated submission of the form to ensure that it's accurate and complete.

Issuance of a registration number by Health Canada

If Health Canada determines that the information is complete, it will:

Health Canada may refuse to register a primary establishment after the review of the registration form.

Health Canada aims to provide a service delivery standard of 90 calendar days from the receipt of a complete application to issue a decision on an application for registration of a primary establishment that processes sperm or ova. This includes the review of initial registration applications or amendment applications.

Health Canada inspectors designated under the AHR Act may inspect establishments prior to or after the issuance of a registration number. This includes both the primary establishment, as well as any establishments conducting activities on behalf of the primary establishment that are listed on the registration application.

Once a primary establishment is registered, they have obligations to submit amendments or changes in accordance with the sections 8 and 11 of the Safety Regulations respectively.

A registration number doesn't expire. However, all registered primary establishments and other establishments that distribute or import sperm or ova must complete an annual attestation.

Refusal

Under section 7 of the Safety Regulations, Health Canada may refuse to register an applicant if:

In cases where Health Canada has determined that a registration may be refused, Health Canada will provide:

Amendments to a registration

Amendments to an application

A primary establishment that processes either sperm or ova, but not both, and proposes to begin processing the other must, before doing so, submit an application to Health Canada to amend its registration. Using the registration form, the primary establishment must provide a description of the proposed amendment, as well as the relevant information from section 5 of the Safety Regulations. For example, if a primary establishment is registered for the processing of sperm and wishes to begin processing ova, or vice versa, they must first submit an amendment to their registration.

Similar to the application for a registration, the application for an amendment must be signed and dated by the senior executive officer and include the attestation from the senior executive officer in accordance with subsection 8(2) of the Safety Regulations.

During the review of the application for amendment, Health Canada may request additional information in order to complete the review. If the applicant receives a written request for additional documents or information from Health Canada, the primary establishment must provide the requested information, on or before the date specified in the request per subsection 8(3) of the Safety Regulations.

If, after reviewing the application for the amendment to the registration, Health Canada determines that the information provided in the application is complete, Health Canada must amend the registration per section 9 of the Safety Regulations.

Refusal to amend

Under section 10 of the Safety Regulations, Health Canada may refuse to amend the registration of the primary establishment if:

In cases where Health Canada has determined that an amendment to a registration may be refused, Health Canada will provide:

Changes to a registration and cessation of activities

A primary establishment must notify Health Canada in writing within 30 days after the day on which:

The establishment must provide a written notice of the information pertaining to the change or cessation of regulated activities, using the registration form, which contains the information set out in subsection 11(2) of the Safety Regulations.

The notice must be signed and dated by the senior executive officer and include an attestation from that senior executive officer as specified in subsection 11(3) of the Safety Regulations.

Health Canada must update the registration to reflect the notice of changes or cessation of regulated activities. Health Canada will send an email to the applicant acknowledging their submission of the change or cessation notice.

Suspension of a registration

Under subsection 13(1) of the Safety Regulations, Health Canada has the authority to suspend, in whole or in part, without prior notice, a primary establishment's registration, if Health Canada has reasonable grounds to believe that human health and safety or the safety of the sperm or ova has been or could be compromised.

Health Canada takes a risk-based approach to identify, assess and manage health and safety risks that can emerge from diverging from the requirements of the Safety Regulations. Health Canada may suspend a registration of a primary establishment without prior notice where Health Canada has reasonable grounds to believe that human health and safety or the safety of the sperm or ova has been or could be compromised. This could include certain cases where the suspension is needed to immediately address or mitigate the effects of a non-compliance that may pose risks to the health and safety of Canadians. For further details related to the factors that Health Canada takes into consideration when determining which type of intervention (that is, enforcement action) is appropriate for non-compliances, please refer to Health Canada's Compliance and enforcement policy for the Assisted Human Reproduction Act (POL-0100).

Notice of suspension

Upon the suspension of a primary establishment's registration, Health Canada must send a notice to the primary establishment per subsection 13(2) of the Safety Regulations, that:

Actions the primary establishment must take

Upon the suspension of a primary establishment's registration, the primary establishment must cease carrying out all of the activities subject to the suspension until Health Canada reinstates the registration. In addition, per subsection 13(3) of the Safety Regulations, the primary establishment must immediately notify every establishment, health professional or recipient to which it has distributed the implicated sperm or ova during the period specified in the notice of the:

Reinstatement of registration

Depending on the circumstances, Health Canada may reinstate a primary establishment's suspended registration. Per subsection 14(1) of the Safety Regulations, a primary establishment can make a request to Health Canada to have their registration reinstated. The request must include evidence to demonstrate that:

Health Canada must reinstate the registration if the primary establishment meets the criteria under subsection 14(1) of the Safety Regulations. The reinstatement takes effect immediately after Health Canada sends the primary establishment a notice to that effect, per subsection 14(2). If Health Canada doesn't reinstate the part of a registration that was suspended, Health Canada must remove that part of the registration.

Despite the obligation to reinstate, Health Canada may refuse to reinstate the primary establishment's registration if the establishment consistently demonstrates an inability to conduct its activities in accordance with the regulations, as outlined in subsection 14(3) of the Safety Regulations. Health Canada interprets this to include scenarios where:

Health Canada will provide the registrant with an opportunity to be heard before making a decision to refuse or reinstate the elements of the registration that are subject to suspension.

Cancellation process for a registration

The Safety Regulations outline circumstances under which a registration can be cancelled. Depending on the situation, either the establishment or Health Canada may initiate the cancellation.

A primary establishment is not permitted to conduct any processing activities when its registration is cancelled. A primary establishment must file a new application in accordance with section 5 of the Safety Regulations if it intends to commence processing activities for which its registration was cancelled, whether the primary establishment or Health Canada initiated the cancellation.

Cancellation of registration initiated by the establishment for cessation of regulated activities

Under section 11 of the Safety Regulations, the primary establishment must submit a notice to Health Canada within 30 days after all activities have ceased if it is ceasing all processing activities that are subject to its registration.

Under section 15 of the Safety Regulations, Health Canada must cancel a registration where Health Canada has received notice that the primary establishment has ceased carrying out all of the activities that are subject of its registration.

Cancellation of registration initiated by Health Canada

There may be instances whereby Health Canada may initiate the cancellation of a primary establishment's registration. Per subsection 16(1) of the Safety Regulations, Health Canada may cancel a registration if:

Notice of cancellation

When Health Canada initiates the cancellation, before cancelling the registration Health Canada must send to the primary establishment a notice per subsection 16(2) of the Safety Regulations that:

When Health Canada cancels a registration under section 16 of the Safety Regulations, the primary establishment must immediately cease carrying out all of the activities that are the subject of its registration. If a primary establishment has ceased all activities and cancels their registration, and then at a later date decides it wishes to begin conducting processing activities, the primary establishment must submit a new registration application in accordance with section 5 of the Safety Regulations.

If a primary establishment has submitted a notice to Health Canada to cancel their registration under section 11, Health Canada will cancel the registration in accordance with section 15 of the Safety Regulations. Health Canada will acknowledge the cancellation when it receives a cancellation request.

Notification

Establishments that intend to distribute or import sperm or ova for the purpose of AHR are subject to notification requirements under section 18 of the Safety Regulations.

Notice before distribution or importation

An establishment must send Health Canada a notice that contains the information specified in subsection 18(1) of the Safety Regulations before distributing or importing sperm or ova. Establishments that intend to begin distributing or importing sperm or ova for the purpose of AHR must submit their notification using the Sperm and ova establishment notification form (FRM-0448), hereinafter referred to as the "notification form."

Subsection 18(1) Notice before distribution or importation

18 (1) Before distributing or importing sperm or ova, an establishment must send to the Minister a notice, in the form established by the Minister, that contains the following information:

  1. the establishment's name, telephone number, email address, postal address and, if different from the postal address, civic address;
  2. in the case of an establishment that previously conducted its activities under another name, either under these Regulations or the Processing and Distribution of Semen for Assisted Conception Regulations, that other name;
  3. the first name, last name, telephone number and email address of a person to contact for further information concerning the notice and, if different, a person to contact in case of emergency;
  4. a statement indicating whether the establishment proposes to distribute or import sperm or ova and the projected start date;
  5. the civic address of the buildings in which the establishment proposes to conduct the activities, if not already provided; and
  6. the name and registration number of each primary establishment that processes that sperm or those ova.

The notification must be signed and dated by a senior executive officer and include an attestation from the senior executive officer attesting to the information set out in subsection 18(2) of the Safety Regulations:

Importation

Section 3 of the Safety Regulations requires that establishments importing sperm or ova ensure that the sperm or ova were processed by a primary establishment registered in accordance with the Safety Regulations. For the purpose of the Safety Regulations, the activity of importation is specific to sperm or ova being brought into Canada, and not importation activities that occur outside of Canada. This means that establishments located outside of Canada engaged in importation in their respective jurisdictions aren't required to notify Health Canada for importation activities that occur outside of Canada.

Under paragraph 18(1)(f) of the Safety Regulations, importers are required to list the registered primary establishments, and their associated registration numbers, responsible for the processing of the sperm or ova that is being imported.

To request a list of registered primary establishments, please contact the Biological Products Compliance Program at bpcp-pcpb@hc-sc.gc.ca.

Third parties that facilitate the importation of donor sperm or ova or that provide administrative support to identify donors (for example, egg bank coordinators) aren't required to be listed on notifications unless they conduct a processing activity on the sperm or ova as defined in the Safety Regulations.

The requirement under paragraph 18(1)(f) of the Safety Regulations is to only list the registered primary establishments, and their associated registration numbers, responsible for processing the sperm or ova that is being imported. Third party coordinators do not need to be listed.

Canadian establishments and health professionals assuming the responsibility of a primary establishment

If a foreign establishment that is processing sperm or ova doesn't wish to register as a primary establishment and the Canadian establishment has registered as a primary establishment (listing the foreign establishment as conducting activities on their behalf), the primary establishment (Canadian establishment) would be considered to be importing and should list themselves as the primary establishment on their notification form per paragraph 18(1)(f) of the Safety Regulations.

Distribution

Health Canada considers distribution of sperm or ova for the purpose of AHR to include the transfer of sperm or ova from one establishment or health professional to another establishment, health professional or individual (that is, recipient). For example:

For the purpose of the Safety Regulations, the activity of distribution is specific to sperm or ova being distributed in Canada, and not distribution activities that occur outside of Canada. Establishments located outside of Canada engaged in distribution in their respective jurisdictions aren't required to notify Health Canada for distribution activities that occur outside of Canada since the requirement to notify Health Canada applies only to distribution activities conducted within Canada.

Information regarding the notification for establishments that distribute

Section 18 of the Safety Regulations requires that establishments include the name and registration number of all primary establishments that processed the sperm or ova intended for distribution as part of the notification requirements. In cases where an establishment may only distribute occasionally (for example, based on patient requests), the information about the primary establishment that processed the sperm or ova may not be available to proactively submit a notification in the event a distribution occurs at a later date. An establishment may proactively submit this notification if your establishment only receives sperm or ova from a set number of primary establishments. However, if this information isn't available at the time of notification, then an establishment must wait and submit the notification once it receives a request to transfer (in other words, distribution) so the appropriate primary establishment's name and registration number can be included. Regardless, the notification must be submitted prior to the distribution and include all of the information required under section 18. Note there's no approval process with respect to a notification. The distribution can proceed as long as the establishment has submitted all the required information as outlined in section 18 of the Safety Regulations. While there's no approval process by Health Canada for notifications, Health Canada will acknowledge the receipt of the notification and contact your establishment if it requires any further clarification.

If an establishment has already notified for distribution, and during the year it receives a request to distribute sperm or ova from a primary establishment that wasn't listed on the initial notification, the additional primary establishment name and registration number need to be added as a change to the notification. An establishment must do this within 30 days of the change per section 19 of the Safety Regulations. Learn more about change or cessation of activities for notifications.

Health professionals

The Safety Regulations apply to all establishments and health professionals who process, import, distribute or make use of donor sperm or ova for the purpose of AHR. However, it's important to note that health professionals aren't required to register or notify Health Canada if they only conduct the activities that fall within the definition of a health professional in the Safety Regulations, as they wouldn't be considered an establishment. Furthermore, section 18 of the Safety Regulations only pertains to "an establishment."

Under the Safety Regulations, a health professional is defined as a person who is authorized by the laws of their province or territory to make use of donor sperm or ova in AHR. A health professional isn't considered an establishment when the health professional only conducts these activities:

Where a health professional conducts any activity other than those listed, the person would be considered an establishment and subject to the relevant requirements of an establishment including the applicable registration or notification requirements. There may be instances where a health professional is requested by a patient to distribute sperm or ova to another establishment (for example, another clinic) or health professional. Since this type of distribution isn't included within the definition of a health professional, then the health professional that distributes in such a manner would be:

Change or cessation

Establishments that have notified are required to submit to Health Canada notices of change or cessation of activities, within 30 days of the change or cessation. In other words, if an establishment that distributes or imports sperm or ova makes any change to the information provided under section 18 of the Safety Regulations, including the cessation of distribution or importation activities, they must submit information per 19(1) of the Safety Regulations using the notification form including:

For example, an establishment has notified Health Canada that they wish to distribute sperm from primary establishment "A" with registration number "XXXXXX." However, during the year, the establishment receives a request to distribute sperm that was processed by primary establishment "B" with registration number "XXXXYZ." This is considered a change, and the establishment is required to submit a notice to Health Canada within 30 days of that change (that is, when the distribution occurred).

Section 19 of the Safety Regulations outlines the requirements when a change occurs to the information provided in the establishment's notification submitted under section 18. However, these changes under section 19 of the Safety Regulations aren't meant to include adding an activity or gamete. For example, an establishment that has notified for the distribution of sperm or ova and wishes to begin importing sperm or ova or an establishment that imports sperm and wishes to begin importing ova must meet the notification requirements of section 18 of the Safety Regulations. These changes are subject to a notification. An establishment must submit a notification per section 18 of the Safety Regulations to Health Canada prior to commencing these additional activities.

The notice must be signed and dated by the senior executive officer and include an attestation from the senior executive officer as specified in subsection 19(2).

Annual attestation

A primary establishment's registration or an establishment's notification doesn't expire. However, all establishments who have registered or notified must submit an annual attestation of compliance by April 1st:

Establishments must submit their annual attestation using the Sperm and ova establishment annual attestation form (FRM-0449), hereinafter referred to as the "attestation form." Although Health Canada may issue reminders to establishments regarding the annual attestation requirements, it's the responsibility of the registered primary establishment and/or establishment that has notified to submit an annual attestation.

If a primary establishment, or an establishment that imports or distributes sperm or ova, doesn't provide their annual attestation, Health Canada may take other compliance and enforcement measures in accordance with the Compliance and enforcement policy for the Assisted Human Reproduction Act (POL-0100). For example, in the case of a registered primary establishment, Health Canada could proceed with cancelling the registration per section 16 of the Safety Regulations.

Annual attestation submission date: April 1 of each year

As outlined in subsection 20(1) of the Safety Regulations, a primary establishment and any other establishment that distributes or imports sperm or ova must send to Health Canada, using the attestation form, an annual attestation on or before April 1 of each year.

In addition, as outlined in subsection 20(2) of the Safety Regulations, the attestation must be signed and dated by a senior executive officer. The attestation must certify the following:

Amalgamations and changes of ownership

The Safety Regulations don't prevent or prohibit business transactions such as amalgamations, mergers, acquisitions or changes of ownership. If the business transaction results in the change of information to the registration or notification, the primary establishment or establishment must submit the required information as outlined in the relevant sections of this document and the instructions included on the form. If the business transaction results in a new legal entity (a new primary establishment) responsible for the processing of sperm and ova, it would need to submit an application for a new registration including signatures and attestations by senior executives of the new entity (per section 5 of the Safety Regulations).

Appendix A: Glossary

Acronyms

AHR Act: Assisted Human Reproduction Act

AHR: Assisted Human Reproduction

Terms

These definitions explain how terms are used in this document. If there is a conflict with a definition in the Assisted Human Reproduction Act or associated regulations and a definition in this document, the definition in the AHR Act or regulations prevails.

Activity in respect of sperm or ova, means any of the following activities:

Establishment: means a person, partnership, unincorporated entity or a part of any of them that conducts an activity (processing, importing or distributing), but only includes a health professional if the health professional conducts an activity that isn't referred to in the definition for health professional.

Health professional: means a person who is authorised under the laws of a province to make use of sperm or ova in that province and who:

Human health and safety: means the health and safety of a recipient of sperm or ova or child created from that sperm or ova to the extent that their health and safety relate to the safety of the sperm or ova.

Primary establishment: means an establishment that conducts all processing activities in respect of sperm or ova, whether it conducts them itself or another establishment conducts any of the processing activities on its behalf.

Appendix B: References

Laws and regulations

Other documents

Websites

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