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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)

Cancellation

Cancellation Initiated by Primary Establishment

Marginal note:Cessation of activities

 The Minister must cancel a registration if the Minister receives a notice under section 11 that the primary establishment has ceased carrying out all of the activities that are the subject of its registration.

Cancellation Initiated by Minister

Marginal note:Circumstances

  •  (1) The Minister may cancel a registration in any of the following circumstances:

    • (a) the primary establishment has not provided the annual statement that is required under section 20;

    • (b) the primary establishment has not complied with the requirements set out in section 21 to provide additional documents or information;

    • (c) any information provided by the primary establishment to the Minister in accordance with these Regulations proves to be false or misleading;

    • (d) the primary establishment fails to take corrective action, within the required period, in accordance with subsection (2) or paragraph 13(2)(c);

    • (e) the corrective action that was taken by the primary establishment in accordance with subsection (2) or paragraph 13(2)(c) has not corrected the situation that gave rise to a notice of suspension or cancellation of the registration;

    • (f) the registration has been suspended for a period of more than 12 months;

    • (g) the Minister has reasonable grounds to believe that the primary establishment does not meet the requirements of these Regulations.

  • Marginal note:Notice

    (2) Before cancelling a registration, the Minister must send to the primary establishment a notice that

    • (a) gives the reasons for the proposed cancellation 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 cancellation of registration

  •  (1) If the registration is cancelled under section 16, the primary establishment must immediately take the following action:

    • (a) cease carrying out all of the activities that are the subject of its registration; and

    • (b) notify any establishment, health professional or recipient to which it has distributed the implicated sperm or ova during the period specified in the notice of the cancellation and the effective date.

  • Marginal note:Action upon notice

    (2) An establishment that has been notified under paragraph (1)(b) or under this subsection must, in turn, 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

    (3) If an establishment gives a notice verbally under this section, that notice must be confirmed in writing within 24 hours after it is given.

Notification

Marginal note:Notice before distribution or importation

  •  (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:

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

    • (b) 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;

    • (c) 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;

    • (d) a statement indicating whether the establishment proposes to distribute or import sperm or ova and the projected start date;

    • (e) the civic address of the buildings in which the establishment proposes to conduct the activities, if not already provided; and

    • (f) the name and registration number of each primary establishment that processes that sperm or those ova.

  • Marginal note:Signature and attestation

    (2) 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 the establishment has evidence demonstrating that it is able to meet the requirements of these Regulations,

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

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

Marginal note:Change or cessation

  •  (1) An establishment that distributes or imports sperm or ova and makes any change to the information provided under section 18, including the cessation of distribution or importation, must send to the Minister, within 30 days after the day on which the change occurs, a notice, in the form established by the Minister, that contains the following information:

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

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

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

  • Marginal note:Signature and attestation

    (2) 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 the establishment has evidence, if it is still distributing or importing sperm or ova, demonstrating that it meets the requirements of these Regulations,

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

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

Annual Attestation

Marginal note:April 1

  •  (1) A primary establishment and any other establishment that distributes or imports sperm or ova must send to the Minister, in the form established by the Minister, an annual attestation

    • (a) on or before April 1 of the calendar year following the year of registration or the year in which the notice of distribution or importation is sent; and

    • (b) on or before April 1 of each subsequent calendar year.

  • Marginal note:Signature and attestation

    (2) The attestation must

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

    • (b) certify that

      • (i) the establishment has evidence demonstrating that it meets the requirements of these Regulations,

      • (ii) in the case of a primary establishment, any other establishment that processes sperm or ova on its behalf meets the requirements of these Regulations,

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

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

Marginal note:Additional documents and information

 An establishment must provide to the Minister, on or before the date specified in the Minister’s written request to that effect, any additional relevant documents or information to demonstrate that the activities it conducts are in compliance with these Regulations.

Donor Suitability

Regular Process

Donor Suitability Assessment and Determination

Marginal note:Donor suitability assessment

 In order to determine whether a donor is suitable, a primary establishment must ensure that a donor suitability assessment is conducted.

 
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