FOOD AND DRUGS ACTSafety of Human Cells, Tissues and Organs for Transplantation RegulationsP.C.2007-91420076
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Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30a of the Food and Drugs Act, hereby makes the annexed Safety of Human Cells, Tissues and Organs for Transplantation Regulations.S.C. 2004, c. 23, s. 2INTERPRETATIONDefinitionsThe following definitions apply in these Regulations.accidentaccidentaccident means an unexpected event that is not attributable to a deviation from the standard operating procedures or applicable laws and that could adversely affect the safety of a transplant recipient or the safety, efficacy or quality of cells, tissues or organs.ActLoiAct means the Food and Drugs Act.adverse reactioneffet indésirableadverse reaction means an undesirable response in the recipient to transplanted cells, tissues or organs, including the transmission of a disease or disease agent.bankedmise en banquebanked, with respect to cells and tissues, means processed cells and tissues that have been determined safe for transplantation and that are stored by the source establishment in its inventory and available for distribution or transplantation.cellcellulecell means the fundamental biological unit of a human organism that is for use in transplantation.distributedistributiondistribute does not include to transplant.donordonneurdonor means a living or deceased person from whom cells, tissues or organs are retrieved.donor assessment recorddossier de l’évaluation du donneurdonor assessment record includes the donor screening, any available donor testing results, information obtained from the donor’s medical records and a copy of the donor consent.donor identification codecode d’identification du donneurdonor identification code means the unique numeric or alphanumeric designation that is assigned by the source establishment to a donor under section 56 and that associates each cell, tissue and organ, or part of one, to that donor.donor screeningévaluation préliminaire du donneurdonor screening means an evaluation based on the donor’s medical and social history and physical examination, the results of any diagnostic procedures performed, and, if applicable, the autopsy.donor suitability assessmentévaluation de l’admissibilité du donneurdonor suitability assessment means an evaluation based on the donor screening andin the case of lymphohematopoietic cells, tissues and organs retrieved from live donors and of tissues retrieved from deceased donors, all donor testing results; andin the case of fresh skin, islet cells and organs retrieved from deceased donors, the donor testing results that are necessary at the time of transplantation.donor testingexamen du donneurdonor testing means the laboratory tests and measurements done on a donor or donor specimen to determine all of the following:whether the donor has or ever had a transmissible disease or is or ever was infected with a transmissible disease agent;donor compatibility; andthe degree of functionality of the cell, tissue or organ that is to be retrieved.errormanquementerror means a deviation from the standard operating procedures or applicable laws that could adversely affect the safety of a transplant recipient or the safety, efficacy or quality of cells, tissues or organs.establishmentétablissementestablishment means a person, a partnership or an unincorporated entity, or a part of any of them, that carries out any of the following activities in respect of cells, tissues or organs:importation;processing;distribution; andtransplantation.exceptional distributiondistribution exceptionnelleexceptional distribution means the distribution under sections 40 to 42 of cells, tissues or organs that have not been processed under these Regulations.exterior labelétiquette extérieureexterior label means the label that is affixed to the exterior package.exterior packageemballage extérieurexterior package means the outermost package in which a cell, tissue or organ is delivered, transported or shipped.general standardnorme généralegeneral standard means National Standard of Canada CAN/CSA-Z900.1 entitled Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements, as amended from time to time.homologoushomologuehomologous, in respect of a cell, tissue or organ, means that the cell, tissue or organ performs the same basic function after transplantation.interior labelétiquette intérieureinterior label means the label that is affixed to the interior package.interior packageemballage intérieurinterior package means the innermost package of a cell, tissue or organ that has a non-sterile exterior.lymphohematopoietic standardnorme sur les cellules lymphohématopoïétiqueslymphohematopoietic standard means National Standard of Canada CAN/CSA-Z900.2.5 entitled Lymphohematopoietic Cells for Transplantation, as amended from time to time.medical directordirecteur médicalmedical director, in respect of an establishment, means a physician or dentist who is licensed under the laws of the jurisdiction in which the establishment is situated to provide health care or dental care and who is responsible for the application of the standard operating procedures and for all medical or dental procedures carried out there, as the case may be.minimally manipulatedmanipulation minimaleminimally manipulated meansin respect of a structural tissue, that the processing does not alter the original characteristics that are relevant to its claimed utility for reconstruction, repair or replacement; andin respect of cells and nonstructural tissue, that the processing does not alter the biological characteristics that are relevant to their claimed utility.ocular standardnorme sur les tissus oculairesocular standard means National Standard of Canada CAN/CSA-Z900.2.4 entitled Ocular Tissues for Transplantation, as amended from time to time.organorganeorgan means a perfusable human organ for use in transplantation, whether whole or in parts, and whose specific function is intended to return after revascularization and reperfusion. It includes any adjunct vessels that are retrieved with the organ for use in organ transplantation.organ standardnorme sur les organesorgan standard means National Standard of Canada CAN/CSA-Z900.2.3 entitled Perfusable Organs for Transplantation, as amended from time to time.package insertencart informatifpackage insert means the document that is prepared by the source establishment to accompany a cell, tissue or organ.processingtraitementprocessing, in respect of cells, tissues and organs, means any of the following activities:donor screening;donor testing;donor suitability assessment;retrieval, except for organs and islet cells;testing and measurements performed on the cells, tissues or organs after they are retrieved;preparation for use in transplantation, except for organs;preservation;quarantine;banking; andpackaging and labelling.quality assurance systemsystème d’assurance de la qualitéquality assurance system means the co-ordinated activities of an establishment that relate to the safety of cells, tissues and organs. It includesthe standard operating procedures;records to demonstrate that the standard operating procedures have been implemented; andaudit processes to verify that the standard operating procedures are being implemented.scientific directordirecteur scientifiquescientific director, in respect of an establishment, means an individual who is responsible for the application of the standard operating procedures and for all technical procedures carried out there.serious adverse reactioneffet indésirable graveserious adverse reaction means an adverse reaction that results in any of the following consequences for the recipient:their in-patient hospitalization or its prolongation;persistent or significant disability or incapacity;medical, dental or surgical intervention to preclude a persistent or significant disability or incapacity;a life-threatening condition; anddeath.source establishmentétablissement centralsource establishment meanssubject to paragraph (b), in the case of an organ from a deceased donor, the relevant organ donation organization;in the case of adjunct vessels that are retrieved with an organ and not used immediately in the organ transplantation, the relevant tissue bank;in the case of an organ from a living donor or lymphohematopoietic cells that are not banked, the relevant transplant establishment;in the case of tissues or banked lymphohematopoietic cells, the relevant cell or tissue bank; andin the case of islet cells, the establishment that prepares the cells for use in transplantation.standard operating proceduresprocédures d’opération normaliséesstandard operating procedures means the component of the quality assurance system that comprises instructions that set out the processes and procedures to follow in carrying out the activities of an establishment.tissuetissutissue means a functional group of human cells for use in transplantation. It includes the cells and tissues listed in the definition tissue in section 3.1 of the general standard, except for paragraphs (g) and (l).tissue standardnorme sur les tissustissue standard means National Standard of Canada CAN/CSA-Z900.2.2 entitled Tissues for Transplantation, as amended from time to time.transplanttransplantationtransplant means to implant cells, tissues or organs into a recipient.APPLICATIONScope of RegulationsThese Regulations apply only to organs and minimally manipulated cells and tissues.Non-application — various therapeutic productsThese Regulations do not apply to any of the following therapeutic products:cells, tissues and organs that are for non-homologous use;cells, tissues and organs that are for autologous use;heart valves and dura mater;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;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;cells, tissues and organs that are the subject of clinical trials under Division 5 of Part C of the Food and Drug Regulations;Class IV medical devices that are regulated under the Medical Devices Regulations;blood components, blood products and whole blood, except for cord blood and peripheral blood for use in lymphohematopoietic cell transplantation;cells and tissues that are regulated under the Assisted Human Reproduction Act or any of its regulations; andsemen that is regulated under the Processing and Distribution of Semen for Assisted Conception Regulations.Non-application — regulationsNo other regulation made under the Act applies to cells, tissues or organs that are the subject of these Regulations.PROHIBITIONTransplantationSubject 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 tissueSubject 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 cellsAn establishment may import an organ or lymphohematopoietic cells from an establishment that is not registered.REGISTRATIONRequirement to registerEvery establishment must be registered under these Regulations, except a retrieval establishment and, subject to subsection (2), a transplant establishment.ExceptionA transplant establishment that distributes cells, tissues or organs must be registered under these Regulations.ApplicationAn 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: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;in the case of an establishment that previously carried out its activities under another name, that other name;a description of the types of cells, tissues and organs that the establishment processes, distributes or imports;a description of the types of processing, distribution or transplantation activities that the establishment carries out or for which it is responsible;the period during which the establishment has been in operation; anda statement dated and signed by the medical director or scientific director that certifies that the establishment is in compliance with these Regulations.Information on requestAn 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.Registration numberOn 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.ValiditySubject to section 9, a registration is valid until December 31 in the year after the year in which the registration number is issued.RefusalThe 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.When registration may be cancelledThe Minister may cancel a registration in the following circumstances:the application for registration contains false or misleading information;the Minister receives a notice under section 13 that states that the establishment has ceased an activity;the establishment has not complied with a request for additional information made under section 14; orthe 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.Actions before cancellationThe Minister must take all of the following actions before cancelling a registration: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; andgive the establishment an opportunity to be heard in writing with respect to the cancellation.Notice of cancellationIf 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.Action by establishment when registration cancelledOn the cancellation of its registration, the establishment must immediately take both of the following steps:cease carrying out the activities that were authorized by the registration; andnotify 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.Cancellation in urgent circumstancesDespite 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 reconsiderAn establishment may, in writing, request the Minister to reconsider the cancellation.Opportunity to be heardThe 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.Ongoing requirement to notify MinisterSubject 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 activityIf 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 noticeThe notice must be dated and signed by the medical director or scientific director and include all of the following information:the establishment’s name and civic address, and its postal address if different;the establishment’s registration number;the date on which the change or cessation became effective; andin the case of the cessation of an activity, the disposition of the cells, tissues and organs in the establishment’s possession.Additional informationAn 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 ESTABLISHMENTResponsibilityA 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.PROCESSINGGeneralDocumented evidenceAn 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.When pooling permittedAn establishment may only pool cells, tissues or organs from different donors during processing to create a therapeutic dose for a single recipient.Donor Suitability AssessmentRequirements — cell, tissue and organ donorsIn 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:obtain the donor information and history in accordance with sections 12.2 and 12.3 of the general standard;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;perform a physical examination of the donor in accordance with section 13.2 of the general standard; andperform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the general standard.Plasma dilution algorithmIn 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.Additional exclusion criteria — tissue donorsIn assessing the suitability of a tissue donor, except an ocular tissue donor, an establishment must perform both of the following steps: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; andperform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the tissue standard.Additional exclusion criteria — ocular tissue donorsIn 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.Additional requirements — organ and islet cell donorsIn assessing the suitability of an organ or islet cell donor, an establishment must perform all of the following steps: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;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;perform the tests specified in sections 14.1.2 and 14.3.2 of the organ standard; andperform 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 organsDespite subsection (1), in the case of an imported organ, the transplant establishment need only have the following:documentation of the donor suitability assessment according to the requirements of the jurisdiction where the assessment was performed;documentation that the tests specified in sections 14.1.2 and 14.3.2 of the organ standard have been performed;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; andin 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.Requirements — lymphohematopoietic cellsIn assessing the suitability of a donor of lymphohematopoietic cells, an establishment must perform all of the following steps:obtain the donor information and history in accordance with sections 12.2.2.2 and 12.2.2.3 of the lymphohematopoietic standard;perform a physical examination of the donor in accordance with section 13.2 of the lymphohematopoietic standard;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;perform the tests specified in section 12.2.2.4 of the lymphohematopoietic standard; andperform appropriate and effective tests for the diseases or disease agents specified in section 14.2.3 of the lymphohematopoietic standard.Exception — imported lymphohematopoietic cellsDespite subsection (1), in the case of imported lymphohematopoietic cells, the source establishment musthave documentation of the donor suitability assessment;perform the tests specified in section 12.2.2.4 of the lymphohematopoietic standard;perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.3 of the lymphohematopoietic standard; anddetermine 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.RetrievalRetrieval interval — tissuesAn 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.TestingLicensed diagnostic devicesSubject 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 eitherin Canada, if the testing is performed in Canada; orin Canada or the United States, if the testing is performed outside Canada.Exception — lymphohematopoietic cellsIn 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.In vitro diagnostic devices — cells and tissuesIn 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 — syphilisDespite 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.Bacteriological testing — tissuesAn 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.Packaging and LabellingPackagingPackaging materialsAn 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.LabellingLanguage requirementAll of the information that is required by these Regulations to appear on a label or package insert must be in either English or French.Cells, except islet cellsAn establishment that distributes cells, except islet cells, must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this subsection is provided on the interior label, in the package insert and on the exterior label.
TABLE TO SUBSECTION 30(1)
LABELLING REQUIREMENTS FOR CELLS, EXCEPT ISLET CELLSColumn 1Column 2Column 3Column 4From retrieval establishment to transplant establishmentFrom retrieval establishment to cell bankFrom cell bank to any other establishmentItemRequired informationInterior labelPackage insertExterior labelInterior labelPackage insertExterior labelInterior labelPackage insertExterior labelInformation about donor and cell1.Name of cellXXXXXX2.Description of cellXXX3.Donor identification code, clearly labelled as suchXXXX4.Information capable of identifying the donorXX5.Donor assessment recordX6.ABO group and Rh factor of donor, if applicableXXXXXX7.The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicableXXXXXXRetrieval information8.Date, time and time zone of retrievalXX9.Information specific to retrieval procedureXXProcessing information10.Name of anticoagulant and other additive, if applicableXXX11.Statement “For Autologous Use Only”, if applicableXXXXXXInformation for transplant establishment12.Statement that the cell has been declared safe for transplantationX13.Statement “For Exceptional Distribution”, if applicableXX14.If applicable, the reasons for exceptional distribution and a statement of how the cell does not meet the requirements of these RegulationsXX15.Instructions on how to report errors, accidents and adverse reactionsX16.Expiry date and time, if applicableXXEstablishment information17.Name of retrieval establishment, its civic address and contact informationXXXX18.Name of source establishment, its civic address and contact informationXXXXXX19.Registration number of source establishment, clearly labelled as suchXXXX20.Name of transplant establishment, if known, its civic address and contact informationXXStorage information21.Statement “Human cells for transplant”XXX22.Handling instructions for storage and for storage during transportationXXX
Pancreas and islet cellsAn establishment that distributes a pancreas for islet cell transplantation, or islet cells, must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this subsection is provided on the interior label, in the package insert and on the exterior label.
TABLE TO SUBSECTION 30(2)
LABELLING REQUIREMENTS FOR PANCREAS AND ISLET CELLSColumn 1Column 2Column 3PANCREAS: From retrieval establishment to source establishmentISLET CELLS: From source establishment to any other establishmentItemRequired informationInterior labelPackage insertExterior labelInterior labelPackage insertExterior labelInformation about donor and organ or islet cells1.Name of organ or cells, as applicableXXXX2.Description of organ or cells, as applicableXX3.Donor identification code, clearly labelled as suchXX4.Information capable of identifying the donorXX5.Donor assessment recordX6.ABO group and Rh factor of donor, if applicableXXXX7.The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicableXXXXRetrieval information8.Date, time and time zone of asystole or aortic clamping, if applicableX9.Date, time and time zone of retrievalX10.Information specific to retrieval procedureX11.Name of perfusion solutionXProcessing information12.Name of storage solutionX13.Name of additives, if applicableXInformation for establishments14.Statement that the cells have been declared safe for transplantationX15.Statement “For Exceptional Distribution”, if applicableXXX16.If applicable, the reasons for exceptional distribution and a statement of how the organ or cells do not meet the requirements of these RegulationsXX17.Instructions on how to report errors, accidents and adverse reactionsXX18.Expiry date and time, if applicableXXEstablishment information19.Name of retrieval establishment, its civic address and contact informationXXXX20.Name of source establishment, its civic address and contact informationXXXX21.Registration number of source establishment, clearly labelled as suchXXXX22.Name of other establishment, its civic address and contact informationXStorage information23.Statement “Human organ for transplant” or “Human cells for transplant”, as applicableXX24.Handling instructions for storage and for storage during transportationXX
TissuesAn 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 1Column 2Column 3From retrieval establishment to tissue bankFrom tissue bank to any other establishmentItemRequired informationInterior labelPackage insertExterior labelInterior labelPackage insertExterior labelInformation about donor and tissue1.Name of tissue, and whether left or right side, if applicableXXXX2.Description of tissueXX3.Donor identification code, clearly labelled as suchXX4.Information capable of identifying the donorXX5.Donor assessment recordX6.The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicableXXXXRetrieval information7.Date, time and time zone of asystole or aortic clamping, if applicableX8.Date, time and time zone of retrievalX9.Information specific to retrieval procedureXProcessing information10.Name of storage solution, if applicableXX11.Name of anticoagulant and other additive, if applicableX12.Statement that the tissue has been irradiated, if applicableXX13.Description of the disinfection and sterilization processes that were used, if applicableX14.Statement “For Autologous Use Only”, if applicableXXXXInformation for transplant establishment15.Tissue-specific instructions for preparation for use, if applicableX16.Statement that the tissue has been declared safe for transplantationX17.Statement “For Exceptional Distribution”, if applicableXX18.If applicable, the reasons for exceptional distribution and a statement of how the tissue does not meet the requirements of these RegulationsX19.Instructions on how to report errors, accidents and adverse reactionsX20.Expiry date and time, if applicableXXEstablishment information21.Name of retrieval establishment, its civic address and contact informationXX22.Name of source establishment, its civic address and contact informationXXXX23.Registration number of source establishment, clearly labelled as suchXX24.Name of transplant establishment, if known, its civic address and contact informationXStorage information25.Statement “Human tissue for transplant”XX26.Handling instructions for storage and for storage during transportationXX
OrgansAn 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 1Column 2Column 3DECEASED DONOR: From retrieval establishment to transplant establishmentLIVING DONOR: From retrieval establishment to transplant establishmentItemRequired informationInterior labelPackage insertExterior labelInterior labelPackage insertExterior labelInformation about donor and organ1.Name of organ, and whether left or right side, if applicableXXXXX2.Description of organXX3.Donor identification code, clearly labelled as suchXXXX4.All information in the donor assessment record that is not capable of identifying the donorX5.ABO group and Rh factor of donorXXXX6.The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicableXXXXRetrieval information7.Date, time and time zone of asystole or aortic clamping, if applicableX8.Date, time and time zone of retrievalXX9.Information specific to retrieval procedureXX10.Name of perfusion solutionXXProcessing information11.Name of storage solutionXXInformation for transplant establishment12.Statement that the organ has been declared safe for transplantationX13.Statement “For Exceptional Distribution”, if applicableXXXX14.If applicable, the reasons for exceptional distribution and a statement of how the organ does not meet the requirements of these RegulationsXX15.Instructions on how to report errors, accidents and adverse reactionsXXEstablishment information16.Name of retrieval establishment, its civic address and contact informationXXXX17.Name of source establishment, its civic address and contact informationXXXX18.Registration number of source establishment, clearly labelled as suchXXXX19.Name of transplant establishment, its civic address and contact informationXXStorage information20.Statement “Human organ for transplant”XX21.Handling instructions for storage and for storage during transportationXX
Additional information requiredA 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:on the exterior label and in the package insert, the name of the establishment, its civic address and contact information; andon the exterior label and in the package insert, the establishment’s registration number.QuarantineQuarantine — cells and tissuesA source establishment must ensure that cells, except islet cells, and tissues are quarantined until all of the following processing activities are completed:the donor is found to be suitable after completion of the donor suitability assessment;except in the case of fresh skin, bacteriological test results are reviewed and found to be acceptable, if applicable; andall processing records are reviewed for completeness and compliance with the standard operating procedures.Additional requirement — live donors of tissueIn addition to the requirements set out in subsection (1), the source establishment must quarantine tissues that are retrieved from live donors in accordance with section 17.2 of the tissue standard.STORAGEStorage limitsAn establishment that distributes cells, tissues or organs and that stores cells, tissues and adjunct vessels that were not used at the time of transplantation of the organ with which they were retrieved must observe scientifically based maximum storage periods.Storage locationAn establishment that distributes cells, tissues or organs must store them in a location that has appropriate environmental conditions that maintain their safety and that is secure against the entry of unauthorized persons.Storage during transportationAn establishment that ships cells, tissues or organs must ensure that they are stored during transportation in appropriate environmental conditions.Segregation — tissuesAn establishment that stores tissues must ensure that those that are intended for autologous use are segregated from those intended for allogeneic use.Segregation — transmissible disease agents and markersAn establishment that stores cells, tissues or organs must ensure that any of them that are untested or for which the results of tests on donor blood samples are positive or reactive for transmissible disease agents or markers or are unavailable are segregated from all other cells, tissues and organs.EXCEPTIONAL DISTRIBUTIONConditionsA source establishment may distribute cells, tissues or organs that have not been determined safe for transplantation if all of the following conditions are met:a cell, tissue or organ that has been determined safe for transplantation is not immediately available;the transplant physician or dentist, based on their clinical judgement, authorizes the exceptional distribution; andthe transplant establishment obtains the informed consent of the recipient.Notice in source establishment’s recordsA source establishment that distributes cells, tissues or organs under section 40 must keep a copy of the notice of exceptional distribution in its records.Notice in transplant establishment’s recordsThe transplant establishment must keep a copy of the notice of exceptional distribution in its records.Contents of noticeA notice of exceptional distribution must contain all of the following information:the name of the transplanted cell, tissue or organ;the provisions of these Regulations with which the cell, tissue or organ is not in compliance at the time of its distribution;the justification for the distribution that formed the basis for the transplant physician’s or dentist’s decision to authorize it;the name of the source establishment that distributed the cell, tissue or organ;the name of the transplant establishment and of the transplant physician or dentist who authorized the distribution; andthe time and date of the written authorization of the distribution and a copy of the authorization signed by the transplant physician or dentist.Follow-upA source establishment that distributes a cell, tissue or organ under section 40 before the donor suitability assessment is complete must, after the distribution, complete the assessment, carry out any other appropriate follow-up testing and notify the relevant transplant establishment of the results.ERROR, ACCIDENT AND ADVERSE REACTION INVESTIGATION AND REPORTINGErrors and AccidentsRequired actionSubject to subsection (2), an establishment that is not a source establishment and that has reasonable grounds to believe that the safety of a cell, tissue or organ that is or was in its possession has been compromised by the occurrence of an error or accident during processing must immediately take all of the following steps:determine the donor identification codes of all implicated cells, tissues and organs;identify and quarantine any other implicated cells, tissues and organs in its possession; andnotify the following establishments:the relevant source establishment, andif the cells, tissues or organs were imported, the establishment that imported them.Exception — importersIf the establishment that receives a notice under subsection (1) is the establishment that imported the implicated cells, tissues or organs, it only has to notify the source establishment.Contents of noticeThe notice must include all of the following information:the reasons for the establishment’s belief that the safety of cells, tissues or organs has been compromised;an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;the donor identification codes of all implicated cells, tissues and organs; andthe name of any suspected transmissible disease or disease agent, if known.Written noticeIf the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.Action by source establishmentA source establishment that has reasonable grounds to believe that the safety of cells, tissues or organs for whose processing it is responsible has been compromised by the occurrence of an error or accident during processing must immediately take all of the following actions:quarantine any implicated cells, tissues and organs in its possession;send a notice described in subsection (2) to all of the following establishments:if the cells, tissues or organs were imported, the establishment that imported them,any source establishment from which it received the donor referral, if applicable,any source establishment to which it made a donor referral, if applicable, andany establishment to which it distributed implicated cells, tissues or organs; andinitiate an investigation into the suspected error or accident.Contents of noticeThe notice must include all of the following information:the reasons for its belief that the safety of the cells, tissues or organs has been compromised;an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;the donor identification codes of all implicated cells, tissues and organs;the name of any suspected transmissible disease or disease agent, if known; anda statement requiring all implicated cells, tissues and organs to be quarantined immediately and until further notice from the source establishment and specifying any other corrective action that must be taken.When no investigation necessaryIf, on receipt of a notice under subsection 43(1), the source establishment does not have reasonable grounds to believe that an investigation is necessary, it must notify the establishment to that effect in writing and provide its reasons for the decision not to conduct an investigation.Action on receipt of noticeAn establishment that is not a source establishment and that receives a notice under section 44 or a copy of such a notice under this section must immediately take both of the following actions:quarantine all implicated cells, tissues and organs in its possession; andforward a copy of the notice to every establishment to which it distributed implicated cells, tissues or organs.Adverse ReactionsRequired actionSubject to subsection (2), an establishment that is not a source establishment and that has reasonable grounds to believe that an unexpected adverse reaction has occurred must immediately take all of the following steps:determine the donor identification codes of the transplanted cells, tissues or organs;identify and quarantine any other cells, tissues and organs in its possession that could potentially cause an adverse reaction in the same way as the transplanted cells, tissues or organs; andnotify the following establishments:the relevant source establishment, andif the cells, tissues or organs were imported, the establishment that imported them.Exception — importersIf the establishment that receives a notice under subsection (1) is the establishment that imported the implicated cells, tissues or organs, it only has to notify the source establishment.Contents of noticeThe notice must include all of the following information:a description of the adverse reaction;the donor identification codes of all implicated cells, tissues and organs; andthe name of any suspected transmissible disease or disease agent, if known.Written noticeIf the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.Action by source establishmentA source establishment that has reasonable grounds to believe that an unexpected adverse reaction has occurred that involves cells, tissues or organs for whose processing it is responsible must immediately take all of the following actions:quarantine any implicated cells, tissues and organs in its possession;send a notice described in subsection (2) to all of the following establishments:if the implicated cells, tissues or organs were imported, the establishment that imported them,any source establishment from which it received the donor referral, if applicable,any source establishment to which it made a donor referral, andany establishment to which it distributed implicated cells, tissues or organs; andinitiate an investigation into the adverse reaction.Contents of noticeThe notice must include all of the following information:a description of the nature of the adverse reaction;an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;the donor identification codes of all implicated cells, tissues and organs;the name of any suspected transmissible disease or disease agent, if known; anda statement requiring all implicated cells, tissues and organs to be quarantined immediately and until further notice from the source establishment and specifying any other corrective action that must be taken.Action on receipt of noticeAn establishment that is not a source establishment and that receives a notice under section 48 or a copy of such a notice under this section must immediately take both of the following actions:quarantine all implicated cells, tissues and organs in its possession; andforward a copy of the notice to every establishment to which it distributed implicated cells, tissues or organs.Investigations and ReportingRequirement to cooperateAn establishment must provide the source establishment that is conducting an investigation with any relevant information in its possession with respect to cells, tissues or organs that it distributed or transplanted.Reports to MinisterA source establishment that is conducting an investigation into either of the following subject-matters must provide the Minister with the reports described in subsection (2):a suspected error or accident that is identified after distribution of cells, tissues or organs that could lead to a serious adverse reaction involving the transmission of an infectious disease or disease agent; andan unexpected serious adverse reaction that is thought to involve the transmission of an infectious disease or disease agent.Contents and timingThe reports must include the following information and be provided at the following times:within 24 hours after the start of the investigation, a preliminary report that includes all relevant information that is available at that time; andwithin 15 days after the start of the investigation and every 15 days after that until the final report is made, an update on any new information about the suspected error or accident or serious adverse reaction, on the progress made in the investigation during those 15 days and on the steps taken to mitigate further risks.When investigation shows no contamination or compromiseIf the results of the investigation show that the implicated cells, tissues or organs are not contaminated or compromised, the source establishment must notify every establishment that was notified under section 44 or 48 to that effect in writing and that they may be released from quarantine.Forwarding of copies of noticeOn receipt of a notice under subsection (1), an establishment that is not a source establishment must forward a copy of the notice to every establishment to whom it distributed implicated cells, tissues or organs.When investigation inconclusive or shows contamination or compromiseIf the results of the investigation show that some or all of the implicated cells, tissues or organs are contaminated or compromised, or the results are inconclusive, the source establishment must notify every establishment that was notified under section 44 or 48 to that effect in writing and that they may not be released for distribution.Forwarding of copies of noticeOn receipt of a notice under subsection (1), an establishment that is not a source establishment must forward a copy of the notice to every establishment to whom it distributed implicated cells, tissues or organs.Final report to MinisterOn completion of an investigation , the source establishment must submit a detailed final report to the Minister that contains at least all of the following information:the results of the investigation;the final disposition of the cells, tissues and organs that were the subject of the investigation and the reasons for that disposition; andany corrective actions taken.Summaries of final reportsThe source establishment must send a summary of the final report to every establishment that was notified under section 44 or 48.Forwarding of summariesAn establishment that receives a summary under subsection (2) must send a copy of it to every establishment to which it distributed implicated cells, tissues or organs.RECORDSRecord qualityRecords kept by an establishment must be accurate, complete, legible and indelible.Donor identification code — source establishmentA source establishment must assign a donor identification code to each donor of a cell, tissue or organ for which it has responsibility.Donor identification code — all establishmentsEvery registered establishment and transplant establishment must ensure that the donor identification code is a component of its records system.RequirementAn establishment’s records must contain information with respect to all cells, tissues and organs that it processes, distributes, imports or transplants that identifiesthe establishment from which it receives the cells, tissues and organs; andall establishments to which it distributes the cells, tissues and organs.Shipping documentsAn establishment’s records must include all shipping documents with respect to cells, tissues and organs that it ships to another establishment.Source establishment recordsThe source establishment must keep records with respect to cells, tissues and organs that it processes that contain at least all of the following information:the donor identification code;documentation showing completion of the donor suitability assessment;a description of the cells, tissues and organs retrieved from the donor;if applicable, the name of any source establishment from which it received a donor referral or to which it made a donor referral;the name of the retrieval establishment;documentation of all processing activities;the notice of exceptional distribution, if any; anddocumentation of any reported errors, accidents and adverse reactions and their investigation, if any, in connection with cells, tissues or organs retrieved from the donor that it banked or distributed and any corrective action taken.Transplant establishment recordsThe transplant establishment must keep records with respect to cells, tissues and organs that it transplants that contain at least all of the following information:a description of the transplanted cells, tissues or organs;the donor identification code;the registration number of the source establishment;the notice of exceptional distribution, if any, and confirmation that the donor suitability assessment was completed as required by section 42;information that allows the identification of the recipient; anddocumentation of any errors, accidents and adverse reactions and their investigation in connection with those cells, tissues or organs and any corrective action taken.Establishments to cooperateAn establishment must provide the source establishment and the transplant establishment with all of the information described in sections 59 and 60, respectively, that it possesses to complete the establishment’s records.Retention — 10 years after transplantationAn establishment must keep the following records for at least 10 years after the date of transplantation, if known, or for at least 10 years after the date of distribution, final disposition or expiry of the cell, tissue or organ, as the case may be, whichever is the latest:the records described in section 57;the records described in section 59, except paragraph (h);the records described in section 60, except paragraph (f); andthe record of destruction or other disposition of the cell, tissue or organ, if applicable.Retention — 10 years after record creationAn establishment must keep the following records for 10 years after the date of their creation:the records described in paragraphs 59(h) and 60(f); andreports of audits conducted under section 76, if applicable.Retention — employee recordsAn establishment that distributes cells, tissues or organs must keep records of the qualifications, training and competency of its employees for 10 years after the time an individual ceases to be an employee of the establishment.Retention — standard operating proceduresAn establishment that distributes cells, tissues or organs must keep a copy of every version of its standard operating procedures for 10 years after they are superseded by a new version.Storage of recordsAn establishment that distributes cells, tissues or organs must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons.PERSONNEL, FACILITIES, EQUIPMENT AND SUPPLIESPersonnelSufficient number and qualificationsAn establishment that distributes cells, tissues or organs must have sufficient personnel who are qualified by education, training or experience to perform their respective tasks to carry out the establishment’s activities.CompetencyAn establishment that distributes cells, tissues or organs must have a system for the orientation and training, both initial and ongoing, of personnel and for the evaluation of their competency.FacilitiesRequirementsThe facilities of an establishment that distributes cells, tissues or organs must be constructed and maintained to permit all of the following:the carrying out of all of its activities;the efficient cleaning, maintenance and disinfection of the facilities in a way that prevents contamination and cross-contamination;environmental and microbiological monitoring and control appropriate to the areas where its activities are carried out; andcontrolled access to all areas where its activities are carried out.Equipment and SuppliesRequirements — equipmentAn establishment that distributes cells, tissues or organs, in carrying out its processing and storage activities, must use equipment that is cleaned and maintained and, whenever applicable,qualified for its intended purpose;calibrated;disinfected or sterilized before each use; andrequalified or recalibrated, as appropriate, after any repair or change is made to it that results in a change to its specifications.Requirements — storage equipmentAn establishment that distributes cells, tissues or organs that uses equipment to store cells, tissues or adjunct vessels that are not used immediately in organ transplantation must ensure that the equipment maintains appropriate environmental conditions.Processing suppliesAn establishment that processes cells, tissues or organs must use qualified supplies for those activities that could affect the safety of the cells, tissues or organs, and must store solutions, reagents and other supplies under appropriate environmental conditions.Cleaning suppliesAn establishment that processes cells, tissues or organs must ensure that it uses supplies for cleaning, maintenance, disinfection or sterilization that do not react with, or that are not absorbable by, the cells, tissues or organs.QUALITY ASSURANCE SYSTEMGeneralApplicationSections 71 to 76 apply only to establishments that distribute cells, tissues or organs.Quality assurance system requiredAn establishment must ensure that it has a quality assurance system in place that complies with the requirements of these Regulations for all activities that it carries out.Standard Operating ProceduresStandard operating procedures requiredAn establishment must have standard operating procedures with respect to the safety of cells, tissues and organs for all activities that it carries out.RequirementsThe standard operating procedures must meet all of the following requirements:be in a standardized format;be approved by the medical director or scientific director;be available for use at all locations where the relevant activities are carried out;have any changes to the procedures approved by the medical director or scientific director before being implemented; andbe kept up-to-date.Routine reviewAn establishment must review its standard operating procedures every two years and again after any amendment to these Regulations.Supplementary reviewAn establishment that receives a summary of a final report of an error, accident or adverse reaction investigation or the report of an audit either of which reveals a deficiency in a standard operating procedure must review that procedure.Records of complianceAn establishment must keep records that demonstrate that it has implemented its standard operating procedures.AuditsAn establishment must conduct an audit every two years of the activities that it carries out to verify that those activities comply with these Regulations and with its standard operating procedures, by a person who does not have direct responsibility for the activities being audited.POWERS OF INSPECTORSTaking photographsAn inspector may, in the administration of these Regulations, take photographs of any of the following:any article that is referred to in subsection 23(2) of the Act;any place where the inspector believes on reasonable grounds that any article referred to in paragraph (a) is processed; andanything that the inspector believes on reasonable grounds is used or is capable of being used in the processing of any article referred to in paragraph (a).TRANSITIONAL PROVISIONProcessed within 5 years before registrationSubject to subsection (2), the following establishments may import, distribute or transplant, as the case may be, cells and tissues that were processed within five years before the day on which these Regulations are registered:a registered establishment; anda transplant establishment that does not distribute cells or tissues.ProhibitionAn establishment may not import, distribute or transplant, as the case may be, cells or tissues under subsection (1) unless the requirements of subsection 56(2) and section 57 are met.COMING INTO FORCESix months after registrationThese Regulations, except subsection 26(1), come into force six months after the day on which they are registered.ExceptionSubsection 26(1) comes into force one year after the day on which these Regulations are registered.Transitional provisionSection 78 ceases to be in force five years after the day on which these Regulations are registered.[Note: Regulations, except subsection 26(1), in force December 8, 2007; Subsection 26(1) in force June 8, 2008.]