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

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.

Marginal note:Reinstatement of registration

• 14 (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.

Cancellation

Cancellation Initiated by Primary Establishment

Marginal note:Cessation of activities

15 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

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

  • (a) the primary establishment has not provided the annual attestation 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

• 17 (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

• 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:

  • (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

• 19 (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

• 20 (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.