Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118)

Marginal note:Non-application — various therapeutic products

• 3 (1) These Regulations do not apply to any of the following therapeutic products:

  • (a) cells, tissues and organs that are for non-homologous use;

  • (b) cells, tissues and organs that are for autologous use;

  • (c) heart valves and dura mater;

  • (d) tissues and cells — except for islet cells, and except for lymphohematopoietic cells that are derived from bone marrow, peripheral blood or cord blood — that have a systemic effect and depend on their metabolic activity for their primary function;

  • (e) medical devices that contain cells or tissues and that are the subject of investigational testing involving human subjects under Part 3 of the Medical Devices Regulations;

  • (f) cells, tissues and organs that are the subject of clinical trials under Division 5 of Part C of the Food and Drug Regulations;

  • (g) Class IV medical devices that are regulated under the Medical Devices Regulations;

  • (h) blood components, blood products and whole blood, except for cord blood and peripheral blood for use in lymphohematopoietic cell transplantation;

  • (i) cells and tissues that are regulated under the Assisted Human Reproduction Act or any of its regulations.

  • (j) [Repealed, SOR/2019-192, s. 92]

• Marginal note:Non-application — regulations

  (2) No other regulation made under the Act applies to cells, tissues or organs that are the subject of these Regulations.

Prohibition

Marginal note:Transplantation

• 4 (1) Subject to sections 40 to 42, no establishment shall transplant a cell, tissue or organ unless it is processed by a registered establishment under these Regulations and determined safe for transplantation.

• Marginal note:Importation — cells and tissue

  (2) Subject to sections 40 to 42, no establishment shall import tissue or a cell, other than a lymphohematopoietic cell, unless it is processed by a registered establishment under these Regulations and determined safe for transplantation.

• Marginal note:Importation — organs and lymphohematopoietic cells

  (3) An establishment may import an organ or lymphohematopoietic cells from an establishment that is not registered.

Registration

Marginal note:Requirement to register

• 5 (1) Every establishment must be registered under these Regulations, except a retrieval establishment and, subject to subsection (2), a transplant establishment.

• Marginal note:Exception

  (2) A transplant establishment that distributes cells, tissues or organs must be registered under these Regulations.

Marginal note:Application

• 6 (1) An application for registration of an establishment must be made in the form established by the Minister, be dated and signed by the medical director or scientific director, and contain all of the following information:

  • (a) the establishment’s name and civic address, and its postal address if different, and the name and telephone number of a person to contact for further information with respect to the application;

  • (b) in the case of an establishment that previously carried out its activities under another name, that other name;

  • (c) a description of the types of cells, tissues and organs that the establishment processes, distributes or imports;

  • (d) a description of the types of processing, distribution or transplantation activities that the establishment carries out or for which it is responsible;

  • (e) the period during which the establishment has been in operation; and

  • (f) a statement dated and signed by the medical director or scientific director that certifies that the establishment is in compliance with these Regulations.

• Marginal note:Information on request

  (2) An establishment must provide the Minister, on written request, with any relevant information necessary to complete the application, by the date specified in the Minister’s request.

Marginal note:Registration number

• 7 (1) On review of an application for registration, if the Minister determines that the information provided in the application is complete, the Minister must register the establishment and issue a registration number.

• Marginal note:Validity

  (2) Subject to section 9, a registration is valid until December 31 in the year after the year in which the registration number is issued.

Marginal note:Refusal

8 The Minister may refuse to register an establishment if he or she has reason to believe that any of the information provided by the establishment in its application is false, misleading, inaccurate or incomplete.

Marginal note:When registration may be cancelled

9 The Minister may cancel a registration in the following circumstances:

• (a) the application for registration contains false or misleading information;

• (b) the Minister receives a notice under section 13 that states that the establishment has ceased an activity;

• (c) the establishment has not complied with a request for additional information made under section 14; or

• (d) the Minister has reason to believe that the establishment is not in compliance with these Regulations or that the safety of cells, tissues or organs has been or could be compromised.

Marginal note:Actions before cancellation

• 10 (1) The Minister must take all of the following actions before cancelling a registration:

  • (a) send a written notice to the establishment that sets out the reasons for the proposed cancellation and specifies the corrective action, if any, that the establishment must take and the time within which it must be taken; and

  • (b) give the establishment an opportunity to be heard in writing with respect to the cancellation.

• Marginal note:Notice of cancellation

  (2) If the establishment does not carry out the corrective action to the Minister’s satisfaction, or does not carry it out within the required time, the Minister must send a notice of cancellation of the registration that includes the reasons for the cancellation and the effective date.

Marginal note:Action by establishment when registration cancelled

11 On the cancellation of its registration, the establishment must immediately take both of the following steps:

• (a) cease carrying out the activities that were authorized by the registration; and

• (b) notify the establishments to whom it has distributed a cell, tissue or organ or made a donor referral, during the period specified in the notice, of the cancellation, the reasons for the cancellation and the effective date.

Marginal note:Cancellation in urgent circumstances

• 12 (1) Despite section 10, the Minister may cancel a registration immediately if he or she considers it necessary to do so in order to prevent injury to the health or safety of the public, by giving the establishment a notice of the cancellation in writing that states the reasons for the cancellation.

• Marginal note:Request to reconsider

  (2) An establishment may, in writing, request the Minister to reconsider the cancellation.

• Marginal note:Opportunity to be heard

  (3) The Minister must, within 45 days after receiving a request for reconsideration, provide the establishment with an opportunity to be heard in writing with respect to the cancellation.

Marginal note:Ongoing requirement to notify Minister

• 13 (1) Subject to subsection (2), an establishment must notify the Minister in writing of any change in the information provided in its application for registration, within 30 days after the change is made.

• Marginal note:Cessation of activity

  (2) If an establishment ceases to process, distribute or import cells, tissues or organs, it must notify the Minister in writing of that fact, within 90 days after it ceases that activity.

• Marginal note:Contents of notice

  (3) The notice must be dated and signed by the medical director or scientific director and include all of the following information:

  • (a) the establishment’s name and civic address, and its postal address if different;

  • (b) the establishment’s registration number;

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

  • (d) in the case of the cessation of an activity, the disposition of the cells, tissues and organs in the establishment’s possession.

Marginal note:Additional information

14 An establishment must provide the Minister, on written request, with any additional relevant information to demonstrate that the activities it carries out are in compliance with these Regulations, by the date specified in the Minister’s request.

Source Establishment

Marginal note:Responsibility

15 A source establishment is responsible for the processing of cells, tissues and organs, whether the processing is carried out by the source establishment itself or by another establishment, and for determining whether the cells, tissues and organs are safe for transplantation.

Processing

General

Marginal note:Documented evidence

16 An establishment must have documented evidence that demonstrates that the activities, processes and technical procedures that it uses in processing cells, tissues and organs will consistently lead to the expected results.

Marginal note:When pooling permitted

17 An establishment may only pool cells, tissues or organs from different donors during processing to create a therapeutic dose for a single recipient.

Donor Suitability Assessment

Marginal note:Requirements — cell, tissue and organ donors

18 In assessing the suitability of a donor of cells, tissues or organs, except a donor of lymphohematopoietic cells, an establishment must perform all of the following steps:

• (a) obtain the donor information and history in accordance with sections 12.2 and 12.3 of the general standard;

• (b) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.3 of the general standard and in Annex E to that standard;

• (c) perform a physical examination of the donor in accordance with section 13.2 of the general standard; and

• (d) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the general standard.

Marginal note:Plasma dilution algorithm

19 In assessing the suitability of a donor, an establishment must apply a plasma dilution algorithm if a donor pre-transfusion or pre-infusion blood sample is unavailable.

Marginal note:Additional exclusion criteria — tissue donors

20 In assessing the suitability of a tissue donor, except an ocular tissue donor, an establishment must perform both of the following steps:

• (a) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.2 of the tissue standard; and

• (b) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the tissue standard.

Marginal note:Additional exclusion criteria — ocular tissue donors

21 In assessing the suitability of an ocular tissue donor, an establishment must determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in sections 13.1.3 to 13.1.6 of the ocular standard.

Marginal note:Additional requirements — organ and islet cell donors

• 22 (1) In assessing the suitability of an organ or islet cell donor, an establishment must perform all of the following steps:

  • (a) obtain the donor information and history in accordance with sections 12.2.2.3, 12.2.2.4, 12.2.3.4 and 12.2.3.7 of the organ standard;

  • (b) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.2.2 of the organ standard;

  • (c) perform the tests specified in sections 14.1.2 and 14.3.2 of the organ standard; and

  • (d) perform appropriate and effective tests for the diseases or disease agents specified in sections 14.2.6.3 and 14.2.6.6 of the organ standard.

• Marginal note:Exception — imported organs

  (2) Despite subsection (1), in the case of an imported organ, the transplant establishment need only have the following:

  • (a) documentation of the donor suitability assessment according to the requirements of the jurisdiction where the assessment was performed;

  • (b) documentation that the tests specified in sections 14.1.2 and 14.3.2 of the organ standard have been performed;

  • (c) documentation that appropriate and effective tests for the diseases or disease agents specified in sections 14.2.6.3 and 14.2.6.6 of the organ standard have been performed; and

  • (d) in the case of those of the tests for the diseases or disease agents specified in section 14.2.6.3 of the organ standard that must be performed before transplantation and the blood group test for ABO, a copy of the test results.