Safety of Sperm and Ova Regulations (SOR/2019-192)

Interpretation

Marginal note:Definitions

• 1 (1) The following definitions apply in these Regulations.

  accident

  accident means an unexpected event that is not attributable to a deviation from the standard operating procedures or applicable laws, including these Regulations and that could compromise human health and safety or the safety of sperm or ova. (accident)

  activity

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

  • (a) processing, which means

    • (i) performing the donor suitability assessment,

    • (ii) obtaining the sperm or ova from a donor,

    • (iii) preparing,

    • (iv) identifying,

    • (v) testing,

    • (vi) preserving,

    • (vii) assessing quality,

    • (viii) labelling,

    • (ix) quarantining, or

    • (x) storing;

  • (b) distributing; and

  • (c) importing. (activité)

  adverse reaction

  adverse reaction means the unexpected presence of an infectious disease agent or the unexpected occurrence of an infectious disease in a recipient of sperm or ova or a child created from that sperm or those ova. (effet indésirable)

  Directive

  Directive means the document entitled Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors, published by the Department of Health, as amended from time to time. (directive)

  donation code

  donation code means the unique group of numbers, letters, symbols or a combination of any of them that identifies the sperm or ova donation. (code d’identification du don)

  donor identification code

  donor identification code means the unique group of numbers, letters, symbols or a combination of any of them that is assigned to a donor. (code d’identification du donneur)

  donor suitability assessment

  donor suitability assessment means an assessment of a donor that is based on the following:

  • (a) donor screening;

  • (b) physical examination of the donor; and

  • (c) donor testing. (évaluation de l’admissibilité du donneur) 

  error

  error means a deviation from the standard operating procedures or applicable laws, including these Regulations, that could compromise human health and safety or the safety of sperm or ova. (manquement)

  establishment

  establishment means a person, partnership, unincorporated entity or a part of any of them that conducts an activity but only includes a health professional if the health professional conducts an activity that is not referred to in the definition health professional. (établissement)

  health professional

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

  • (a) makes use of sperm or ova or distributes sperm to a recipient for their personal use;

  • (b) prepares, quarantines, labels or stores sperm or ova for the purpose of their use by that person; or

  • (c) prepares, quarantines, labels or stores sperm for the purpose of its distribution by that person to a recipient for their personal use. (professionnel de la santé)

  human health and safety

  human health and safety means the health and safety of a recipient of sperm or ova or a child created from that sperm or those ova to the extent that their health and safety relate to the safety of the sperm or ova. (santé et sécurité humaines)

  medical director

  medical director, in respect of a primary establishment, means a person who is authorized under the laws of the jurisdiction in which the primary establishment is situated to practise the profession of medicine and who is responsible for all medical and technical procedures carried out during the processing of sperm or ova. (directeur médical)

  primary establishment

  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 activities on its behalf. (établissement principal)

  quarantine

  quarantine, with respect to sperm and ova, means the quarantine described in subsection 28(2) conducted by an establishment or a health professional. (mise en quarantaine)

  standard operating procedures

  standard operating procedures means the component of a quality management system that comprises instructions that set out the processes applicable to the components of the system and to the activities carried out by an establishment. (procédures opérationnelles normalisées)

• Marginal note:Amendments to Directive

  (2) The document referred to in the definition of Directive is deemed to be amended for the purposes of these Regulations if the amendment is not inconsistent with the purpose of reducing risks to human health and safety.

General Requirements

Marginal note:Primary establishment — conformity of processing

• 2 (1) A primary establishment must ensure that sperm or ova are processed in accordance with these Regulations before distributing or making use of them.

• Marginal note:Primary establishment — activities on its behalf

  (2) The primary establishment must ensure that every establishment that conducts any processing on its behalf meets the requirements of these Regulations.

Marginal note:Establishment that imports

3 An establishment that imports sperm or ova must ensure that the sperm or ova are processed by a primary establishment that is registered in accordance with these Regulations.

Registration and Notification

Registration

Application, Issuance and Refusal

Marginal note:Requirement to register — primary establishment

4 A primary establishment that processes sperm or ova must be registered and may process sperm or ova, subject to any change under paragraph 11(1)(a), only in accordance with its registration.

Marginal note:Application

• 5 (1) A primary establishment must submit an application for registration to the Minister, in the form established by the Minister, that contains the following information:

  • (a) the applicant’s name, telephone number, email address, postal address and, if different from the postal address, civic address;

  • (b) in the case of an applicant 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;

  • (c) the first name, last name, telephone number and email address of a person to contact for further information concerning the application and, if different, a person to contact in case of emergency;

  • (d) a statement indicating whether the applicant proposes to process sperm or ova;

  • (e) a list of the processing activities that the applicant proposes to conduct in each building and, if not already provided, the civic address of the respective buildings;

  • (f) a statement indicating whether the applicant proposes to have another establishment process sperm or ova on its behalf; and

  • (g) the name and civic address of any other establishment that the applicant proposes to have conduct any of the processing activities on its behalf, a list of the processing activities that are proposed to be conducted in each building and, if not already provided, the civic address of the respective buildings.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by a senior executive officer; and

  • (b) include an attestation from that senior executive officer of the following:

    • (i) that the applicant has evidence demonstrating that it is able to meet the requirements of these Regulations,

    • (ii) that any other establishment that is proposed to process sperm or ova on its behalf is able to meet the requirements of these Regulations,

    • (iii) that all information submitted in support of the application is accurate and complete, and

    • (iv) that the senior executive officer has the authority to bind the applicant.

• Marginal note:Additional documents and information

  (3) The applicant must provide to the Minister, on or before the date specified in the Minister’s written request to that effect, any documents or information that the Minister considers necessary to complete the Minister’s review of the application.

Marginal note:Registration number

6 If the Minister determines, after reviewing an application for registration, that the information provided in the application is complete, the Minister must register the primary establishment and issue a registration number.

Marginal note:Refusal

7 The Minister may refuse to register an applicant if

• (a) the Minister has reasonable grounds to believe that the applicant has submitted, in the application for registration, false, misleading, inaccurate or incomplete information;

• (b) the applicant has not complied with subsection 5(3) or the documents and information that the applicant has provided under subsection 5(3) are not sufficient to complete the review of the application; or

• (c) the Minister has reasonable grounds to believe that registering the primary establishment could compromise human health and safety or the safety of sperm or ova.

Amendments

Marginal note:Amendments — application

• 8 (1) A primary establishment that processes only one of sperm or ova and proposes to begin processing the other must, before doing so, submit an application to the Minister to amend its registration, in the form established by the Minister, that contains a description of the proposed amendment, as well as the information referred to in section 5 that is relevant to the proposed amendment.

• Marginal note:Signature and attestation

  (2) The application must

  • (a) be signed and dated by a senior executive officer; and

  • (b) include an attestation from that senior executive officer of the following:

    • (i) that the applicant has evidence demonstrating that it is able to meet the requirements of these Regulations,

    • (ii) that any other establishment that is proposed to process sperm or ova on its behalf is able to meet the requirements of these Regulations,

    • (iii) that all information submitted in support of the application is accurate and complete, and

    • (iv) that the senior executive officer has the authority to bind the applicant.

• Marginal note:Additional documents and information

  (3) The primary establishment must provide to the Minister, on or before the date specified in the Minister’s written request to that effect, any documents or information that the Minister considers necessary to complete the Minister’s review of the application.

Marginal note:Amendment

9 If the Minister determines, after reviewing the application for the amendment to the registration, that the information provided in that application is complete, the Minister must amend the registration.

Marginal note:Refusal

10 The Minister may refuse to amend the registration of the primary establishment if

• (a) the Minister has reasonable grounds to believe that the primary establishment has submitted, in the application for amendment, false, misleading, inaccurate or incomplete information;

• (b) the primary establishment has not complied with subsection 8(3) or the documents and information that it has provided under subsection 8(3) are not sufficient to complete the review of the application; or

• (c) the Minister has reasonable grounds to believe that the amendment of the registration could compromise human health and safety or the safety of sperm or ova.

Changes or Cessation

Marginal note:Notice to Minister

• 11 (1) A primary establishment must notify the Minister in writing, in the form established by the Minister, within 30 days after the day on which

  • (a) there is any change to the information provided in the application for registration — other than a change that is the subject of an application for an amendment to the registration — including the cessation of all activities with respect to either sperm or ova if the registration is for both sperm and ova; or

  • (b) the primary establishment has ceased all of its activities.

• Marginal note:Contents of notice

  (2) The notice must contain the following information:

  • (a) the primary establishment’s name, telephone number, email address, postal address and, if different from the postal address, civic address;

  • (b) the primary establishment’s registration number;

  • (c) the date on which the change or cessation became effective; and

  • (d) in the case of cessation, details of the disposition of the sperm or ova that are in the possession or control of the primary establishment.

• Marginal note:Signature and attestation

  (3) The notice must

  • (a) be signed and dated by a senior executive officer; and

  • (b) include an attestation from that senior executive officer of the following:

    • (i) that if the primary establishment has not ceased all of its activities, it has evidence demonstrating that it meets the requirements of these Regulations,

    • (ii) that if the primary establishment has not ceased all of its activities, any other establishment that processes sperm or ova or is proposed to process sperm or ova on its behalf meets the requirements of these Regulations,

    • (iii) that all information submitted in support of the notice is accurate and complete, and

    • (iv) that the senior executive officer has the authority to bind the primary establishment.

Marginal note:Update to registration

12 The Minister must update the registration to reflect the notice.

Suspension

Marginal note:Suspension without notice

• 13 (1) The Minister may suspend, in whole or in part, without prior notice, a primary establishment’s registration, if the Minister has reasonable grounds to believe that human health and safety or the safety of the sperm or ova has been or could be compromised.

• Marginal note:Notice

  (2) If the Minister suspends a registration, the Minister must send a notice to the primary establishment that

  • (a) gives the reasons for the suspension and its effective date;

  • (b) indicates that the primary establishment has an opportunity to be heard; and

  • (c) if applicable, indicates that corrective action must be taken by the primary establishment and the date by which it must do so.

• Marginal note:Action following suspension of registration

  (3) On the suspension of its registration, 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 reasons for its suspension, the effective date of the suspension and the parts of the registration that are the subject of the suspension.

• Marginal note:Action upon notice

  (4) An establishment that has been notified under subsection (3) or under this subsection must immediately notify to the same effect any establishment, health professional or recipient to which it distributed the implicated sperm or ova.

• Marginal note:Written notice

  (5) If the Minister or the establishment gives a notice verbally under this section, that notice must be confirmed in writing as soon as feasible.