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

Regulations are current to 2020-10-05 and last amended on 2020-08-02. Previous Versions

Registration and Notification (continued)

Registration (continued)

Application, Issuance and Refusal (continued)

Marginal note:Registration number

 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

 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

  •  (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

 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

 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

  •  (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

 The Minister must update the registration to reflect the notice.

Suspension

Marginal note:Suspension without notice

  •  (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.

Marginal note:Reinstatement of registration

  •  (1) The Minister must reinstate a registration, in whole or in part, if the primary establishment makes a request to the Minister, in the form established by the Minister, and provides evidence that demonstrates that

    • (a) the primary establishment has corrected the situation that gave rise to the suspension; or

    • (b) the situation that gave rise to the suspension did not exist.

  • Marginal note:Notice

    (2) The reinstatement takes effect immediately after the Minister sends to the primary establishment a notice to that effect.

  • Marginal note:Exception — compliance history

    (3) The Minister may refuse to reinstate a primary establishment’s registration if its compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations.

  • Marginal note:Partial reinstatement

    (4) If the Minister does not reinstate any part of a registration that was suspended, the Minister must remove that part of the registration.

 
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