GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 3
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 (j) [Repealed, SOR/2019-192, s. 92] Non-application — regulations (2) No other regulation made under the Act applies to cells, tissues or organs that are the subject of these Regulations. SOR/2019-192, s. 92
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 4
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. 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. Importation — organs and lymphohematopoietic cells (3) An establishment may import an organ or lymphohematopoietic cells from an establishment that is not registered.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 5
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. Exception (2) A transplant establishment that distributes cells, tissues or organs must be registered under these Regulations.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 6
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. 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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 7
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. 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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 8
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 9
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 10
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. 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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 11
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 12
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. Request to reconsider (2) An establishment may, in writing, request the Minister to reconsider the cancellation. 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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 13
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. 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. 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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 14
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 15
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 16
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 17
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 18
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 19
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 20
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 21
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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 22
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. 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.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 23
Requirements — lymphohematopoietic cells 23 (1) In assessing the suitability of 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 12.2.2.2 and 12.2.2.3 of the lymphohematopoietic standard; (b) perform a physical examination of the donor in accordance with section 13.2 of the lymphohematopoietic standard; (c) 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 lymphohematopoietic standard; (d) perform the tests specified in section 12.2.2.4 of the lymphohematopoietic standard; and (e) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.3 of the lymphohematopoietic standard. Exception — imported lymphohematopoietic cells (2) Despite subsection (1), in the case of imported lymphohematopoietic cells, the source establishment must (a) have documentation of the donor suitability assessment; (b) perform the tests specified in section 12.2.2.4 of the lymphohematopoietic standard; (c) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.3 of the lymphohematopoietic standard; and (d) determine that the donor is not unsuitable to donate on the basis of the exclusion criteria set out in section 13.1.3.4 of the lymphohematopoietic standard.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 24
Retrieval interval — tissues 24 An establishment that retrieves tissue from a deceased donor must carry out the retrieval within the scientifically based maximum interval between the cardiac asystole of the donor and the retrieval of the tissue.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 25
Licensed diagnostic devices 25 (1) Subject to subsection (2), in vitro diagnostic devices that are used by an establishment in the testing of donor blood for transmissible disease agents or markers under these Regulations must be licensed either (a) in Canada, if the testing is performed in Canada; or (b) in Canada or the United States, if the testing is performed outside Canada. Exception — lymphohematopoietic cells (2) In the case of lymphohematopoietic cells that are imported into Canada for transplantation into a specific recipient, the in vitro diagnostic devices may be licensed in Canada or any other jurisdiction.
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In vitro diagnostic devices — cells and tissues 26 (1) In the case of cells and tissues, in vitro diagnostic devices that are used by an establishment in the testing of donor blood for transmissible disease agents or markers under these Regulations must be licensed for screening donors. Exception — syphilis (2) Despite subsection (1), in vitro diagnostic devices that are used in the testing of donor blood for syphilis may be licensed either for diagnosis or screening donors.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 27
Bacteriological testing — tissues 27 An establishment that retrieves tissue, except ocular tissue, must perform bacteriological testing in accordance with section 14.3 of the tissue standard, except for section 14.3.2.8.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 28
Packaging materials 28 An establishment that packages cells, tissues or organs must ensure that it uses appropriate packaging materials that are free from damage and capable of maintaining the integrity of the cells, tissues and organs.
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Language requirement 29 All of the information that is required by these Regulations to appear on a label or package insert must be in either English or French.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 30
storage solution X 13 Name of additives, if applicable X Information for establishments 14 Statement that the cells have been declared safe for transplantation X 15 Statement “For Exceptional Distribution”, if applicable X X X 16 If applicable, the reasons for exceptional distribution and a statement of how the organ or cells do not meet the requirements of these Regulations X X 17 Instructions on how to report errors, accidents and adverse reactions X X 18 Expiry date and time, if applicable X X Establishment information 19 Name of retrieval establishment, its civic address and contact information X X X X 20 Name of source establishment, its civic address and contact information X X X X 21 Registration number of source establishment, clearly labelled as such X X X X 22 Name of other establishment, its civic address and contact information X Storage information 23 Statement “Human organ for transplant” or “Human cells for transplant”, as applicable X X 24 Handling instructions for storage and for storage during transportation X X SOR/2015-17, s. 18
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 31
Tissues 31 An establishment that distributes tissues must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this section is provided on the interior label, in the package insert and on the exterior label. TABLE TO SECTION 31 Labelling Requirements for Tissue Column 1 Column 2 Column 3 From retrieval establishment to tissue bank From tissue bank to any other establishment Item Required information Interior label Package insert Exterior label Interior label Package insert Exterior label Information about donor and tissue 1 Name of tissue, and whether left or right side, if applicable X X X X 2 Description of tissue X X 3 Donor identification code, clearly labelled as such X X 4 Information capable of identifying the donor X X 5 Donor assessment record X 6 The pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous Products Regulations , if applicable X X X X Retrieval information 7 Date, time and time zone of asystole or aortic clamping, if applicable X 8 Date, time and time zone of retrieval X 9 Information specific to retrieval procedure X Processing information 10 Name of storage solution, if applicable X X 11 Name of anticoagulant and other additive, if applicable X 12 Statement that the tissue has been irradiated, if applicable X X 13 Description of the disinfection and sterilization processes that were used, if applicable X 14 Statement “For Autologous Use Only”, if applicable X X X X Information for transplant establishment 15 Tissue-specific instructions for preparation for use, if applicable X 16 Statement that the tissue has been declared safe for transplantation X 17 Statement “For Exceptional Distribution”, if applicable X X 18 If applicable, the reasons for exceptional distribution and a statement of how the tissue does not meet the requirements of these Regulations X 19 Instructions on how to report errors, accidents and adverse reactions X 20 Expiry date and time, if applicable X X Establishment information 21 Name of retrieval establishment, its civic address and contact information X X 22 Name of source establishment, its civic address and contact information X X X X 23 Registration number of source establishment, clearly labelled as such X X 24 Name of transplant establishment, if known, its civic address and contact information X Storage information 25 Statement “Human tissue for transplant” X X 26 Handling instructions for storage and for storage during transportation X X SOR/2015-17, s. 18
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 32
Organs 32 An establishment that distributes organs must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this section is provided on the interior label, in the package insert and on the exterior label. TABLE TO SECTION 32 Labelling Requirements for Organs Column 1 Column 2 Column 3 DECEASED DONOR: From retrieval establishment to transplant establishment LIVING DONOR: From retrieval establishment to transplant establishment Item Required information Interior label Package insert Exterior label Interior label Package insert Exterior label Information about donor and organ 1 Name of organ, and whether left or right side, if applicable X X X X X 2 Description of organ X X 3 Donor identification code, clearly labelled as such X X X X 4 All information in the donor assessment record that is not capable of identifying the donor X 5 ABO group and Rh factor of donor X X X X 6 The pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous Products Regulations , if applicable X X X X Retrieval information 7 Date, time and time zone of asystole or aortic clamping, if applicable X 8 Date, time and time zone of retrieval X X 9 Information specific to retrieval procedure X X 10 Name of perfusion solution X X Processing information 11 Name of storage solution X X Information for transplant establishment 12 Statement that the organ has been declared safe for transplantation X 13 Statement “For Exceptional Distribution”, if applicable X X X X 14 If applicable, the reasons for exceptional distribution and a statement of how the organ does not meet the requirements of these Regulations X X 15 Instructions on how to report errors, accidents and adverse reactions X X Establishment information 16 Name of retrieval establishment, its civic address and contact information X X X X 17 Name of source establishment, its civic address and contact information X X X X 18 Registration number of source establishment, clearly labelled as such X X X X 19 Name of transplant establishment, its civic address and contact information X X Storage information 20 Statement “Human organ for transplant” X X 21 Handling instructions for storage and for storage during transportation X X SOR/2015-17, s. 18
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 33
Additional information required 33 A registered establishment that imports and distributes, or that only distributes, a cell or tissue must ensure that the following information is added to that required by sections 30 and 31 : (a) on the exterior label and in the package insert, the name of the establishment, its civic address and contact information; and (b) on the exterior label and in the package insert, the establishment’s registration number.