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

Regulations are current to 2020-10-21 and last amended on 2020-08-02. Previous Versions

Safety of Sperm and Ova Regulations

SOR/2019-192

ASSISTED HUMAN REPRODUCTION ACT

Registration 2019-06-10

Safety of Sperm and Ova Regulations

P.C. 2019-750 2019-06-09

Whereas, pursuant to subsection 66(1) of the Assisted Human Reproduction ActFootnote a, the Minister of Health has laid a copy of the proposed Safety of Sperm and Ova Regulations before each House of Parliament, substantially in the annexed form;

Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 65Footnote b of the Assisted Human Reproduction ActFootnote a, makes the annexed Safety of Sperm and Ova Regulations.

Interpretation

Marginal note:Definitions

  •  (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

  •  (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

 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

 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

  •  (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.

 
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