GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Blood Regulations — Blood Regulations
donor identification code means the unique group of numbers, letters or symbols, or combination of any of them, that an establishment assigns to a donor. ( code d’identification du donneur )
Blood Regulations — (a)
donor suitability assessment means an evaluation of a donor that is based on all of the following criteria: (a) the donor’s medical history; (b) the results of any donor tests and physical examination; and (c) the donor’s social history, to the extent that it is relevant in determining the presence of risk factors for diseases transmissible by blood. ( évaluation de l’admissibilité du donneur )
Blood Regulations — Blood Regulations
error means a deviation from the operating procedures or applicable laws that could compromise human safety or the safety of blood. ( manquement )
Blood Regulations — (a)
establishment means a person that conducts any of the following activities in respect of blood: (a) importation; (b) processing; (c) distribution; (d) transformation; or (e) transfusion. ( établissement )
Blood Regulations — Blood Regulations
human safety means the safety of donors and recipients of blood, in so far as it relates to the safety of the blood. ( sécurité humaine )
Blood Regulations — Blood Regulations
medical director , in respect of an establishment, means a physician who is entitled under the laws of a province to practise the profession of medicine and who is responsible for all medical procedures carried out by the establishment and for the application of the operating procedures that relate to them. ( directeur médical )
Blood Regulations — Blood Regulations
operating procedures , in respect of an establishment, means the component of the establishment’s quality management system that is composed of instructions that set out the processes to follow in conducting its activities. ( procédures opérationnelles )
Blood Regulations — Blood Regulations
pre-assessed donor means a donor who has been accepted into a pre-assessed donor program described in sections 86 to 91 from whom blood is taken in an emergency to be transfused before completion of the testing. ( donneur pré-évalué )
Blood Regulations — (a)
processing means any of the following activities: (a) donor suitability assessment; (b) collection; (c) testing; or (d) blood component preparation. ( traitement )
Blood Regulations — (a)
safety , in respect of blood, means that the blood has been determined safe for distribution or for autologous transfusion, as the case may be, in accordance with section 73 , and includes (a) in the case of blood for transfusion, its quality and efficacy; and (b) in the case of blood for use in the manufacture of a drug for human use, its quality. ( sécurité )
Blood Regulations — (a)
serious adverse reaction means an adverse reaction that results in any of the following consequences for the donor or recipient: (a) their in-patient hospitalization or its prolongation; (b) persistent or significant disability or incapacity; (c) medical or surgical intervention to preclude a persistent or significant disability or incapacity; (d) a life-threatening condition; or (e) death. ( effet indésirable grave )
Blood Regulations — Blood Regulations
standard means National Standard of Canada CAN/CSA-Z902 published by the Canadian Standards Association and entitled Blood and blood components , as amended from time to time. ( norme )
Blood Regulations — Blood Regulations
transformation , in respect of blood components, means washing, pooling and irradiation that are performed after blood has been determined safe for transfusion. ( transformation )
Blood Regulations — Blood Regulations
unexpected adverse reaction means an adverse reaction that is not identified among the possible adverse reactions either in the circular of information or in any other information provided to the recipient. ( effet indésirable imprévu )
Blood Regulations — 2
Scope of Regulations 2 These Regulations apply to blood that is collected for transfusion or for use in the manufacture of a drug for human use.
Blood Regulations — 3
Non-application — various therapeutic products 3 (1) These Regulations do not apply to any of the following therapeutic products: (a) cord blood and peripheral blood that are for use in lymphohematopoietic cell transplantation and that are regulated under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations ; (b) blood that is the subject of clinical trials under Division 5 of Part C of the Food and Drug Regulations ; or (c) blood that is imported for use in the manufacture of a drug for human use. Non-application — regulations (2) Except for section A.01.045 of the Food and Drug Regulations , no other regulation made under the Act applies to blood that is the subject of these Regulations. Non-application — imported rare phenotypes (3) Sections 4 to 124 do not apply to blood that is of a rare phenotype if it is imported pursuant to a prescription.
Blood Regulations — 4
Allogeneic blood 4 (1) Subject to subsections (2) and (3), an establishment must not import, distribute or transfuse allogeneic blood unless it is processed by an establishment in accordance with an authorization and determined safe for distribution under subsection 73 (1). Exception — pre-assessed donor programs (2) Subsection (1) does not apply if the processing is conducted as part of a pre-assessed donor program. Exception — urgent circumstances (3) An establishment may, in urgent circumstances, (a) import, in accordance with section 92 , allogeneic blood that has not been processed in accordance with an authorization; and (b) distribute or transfuse such blood if the importer imported it in accordance with section 92 . Pre-assessed donors (4) An establishment must not transfuse allogeneic blood that is collected from a pre-assessed donor unless the establishment has complied with the requirements of sections 86 to 91 . Transformations (5) An establishment must not distribute or transfuse blood that has been transformed unless the transformation is conducted by a registered establishment. Autologous blood (6) An establishment must not distribute or transfuse autologous blood unless it has been processed by a registered establishment and determined safe for autologous transfusion under subsection 73 (2). Investigations (7) An establishment must not distribute or transfuse blood in either of the following circumstances: (a) while the blood is in quarantine; or (b) when the results of an investigation into a suspected error or accident or an unexpected adverse reaction or serious adverse reaction are inconclusive or indicate that there has been a compromise to the safety of the blood.
Blood Regulations — 5
Authorization — processing 5 (1) Except for an establishment that only tests blood, an establishment that processes allogeneic blood must have an authorization to do so. Exception — pre-assessed donor programs (2) Subsection (1) does not apply if the processing is conducted as part of a pre-assessed donor program. Authorization — importation (3) Subject to section 92 , an establishment that imports blood must have an authorization to do so, unless the blood is already the subject of another establishment’s authorization.
Blood Regulations — 6
Application for authorization 6 (1) An establishment must file with the Minister an application for an authorization in the form established by the Minister. The application must be dated and signed by a senior executive officer and contain all of the following information: (a) the applicant’s name and civic address, and its postal address if different, and the civic address of each building in which it proposes to conduct its activities; (b) the name and telephone number, fax number, email address or other means of communication of a person to contact for further information concerning the application; (c) the name and telephone number of a person to contact in an emergency, if different from the person mentioned in paragraph (b); (d) a statement of whether the establishment proposes to import whole blood or blood components; (e) a list of the whole blood and blood components that the establishment proposes to process or import; (f) a list of the processing activities that are proposed to be conducted in each building; (g) a description of the establishment’s facilities, including its buildings and all critical equipment, supplies and services that it proposes to use in the conduct of its activities; (h) a description of the processes that the establishment proposes to use or to have used on its behalf in respect of blood and each blood component in the conduct of its activities; (i) a draft of each proposed label and circular of information; (j) evidence that any foreign establishment that it proposes to have conduct any of its processing activities is licensed in the foreign jurisdiction; and (k) sufficient evidence to demonstrate that the proposed processes will not compromise human safety and will result in blood that can be determined safe for distribution. Site inspection (2) During the review of an application, the Minister may inspect the establishment’s facilities to evaluate on site the information provided in the application. Information on request (3) An establishment must provide the Minister, on written request, with any information that the Minister determines is necessary to complete the Minister’s review of the application, by the date specified in the request.
Blood Regulations — 7
Issuance 7 On completion of the review of an application, the Minister must issue an authorization, with or without terms or conditions, if she or he determines that the establishment has provided sufficient evidence to demonstrate that issuance of the authorization will not compromise human safety or the safety of blood.
Blood Regulations — 8
Refusal 8 The Minister may refuse to issue an authorization if she or he determines that the information provided by the establishment in its application is inaccurate or incomplete.
Blood Regulations — 9
Significant changes 9 (1) Before making a significant change, an establishment must file with the Minister an application to amend its authorization and include with it all relevant information to enable the Minister to determine whether the change or the way in which it is implemented could compromise human safety or the safety of blood. Applications to amend (2) Sections 6 to 8 apply to an application to amend an authorization, with any necessary modifications. Meaning of significant change (3) In this section and sections 10 and 12 , significant change means any of the following changes: (a) the addition of blood or a blood component to the list required by paragraph 6 (1)(e); (b) the deletion of or a change to any authorized process; (c) the addition of a process described in paragraph 6 (1)(h); or (d) a change to the description of the establishment’s facilities referred to in paragraph 6 (1)(g).
Blood Regulations — 10
Emergency changes 10 (1) In an emergency, if it becomes necessary for an establishment to implement a significant change before filing an application to amend its authorization, the establishment may do so if the change is necessary to prevent a compromise to human safety or the safety of blood. Notice and application (2) The establishment must notify the Minister in writing of any significant change that it implements under subsection (1) no later than the day after implementing it and file an application to amend its authorization within 15 days after the day on which that notice is given.
Blood Regulations — 11
Administrative changes — notice 11 An establishment must notify the Minister in writing of any change to the information provided under paragraphs 6 (1)(a) to (c) as soon as possible after the change is made, and the Minister must amend the authorization accordingly.
Blood Regulations — 12
Other changes — annual report 12 (1) An establishment must file with the Minister an annual report that describes any changes made in the year that are not described in section 9 or 11 and that could compromise human safety or the safety of blood. Amendment by Minister (2) On receipt of the report, the Minister must amend the establishment’s authorization accordingly. When changes determined significant (3) If the Minister determines that a change that was included in a report under subsection (1) is a significant change, the Minister must notify the establishment in writing to that effect and may require the establishment to cease or reverse the implementation of the change. Application to amend authorization (4) On receipt of the notice, the establishment must file an application to amend its authorization
Blood Regulations — 13
New or amended terms and conditions 13 (1) The Minister may add terms and conditions to an establishment’s authorization or amend its terms and conditions in either of the following circumstances: (a) the Minister has reasonable grounds to believe that it is necessary to do so to prevent a compromise to human safety or the safety of blood; or (b) the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that its processes will not compromise human safety and will result in blood that can be determined safe for distribution, by the date specified in the request. Notice (2) Before adding terms or conditions to an authorization or amending its terms or conditions, the Minister must send the establishment a notice at least 15 days before the proposed terms and conditions are to take effect that sets out the Minister’s reasons and that gives the establishment a reasonable opportunity to be heard concerning them. Urgent circumstances (3) Despite subsection (2), the Minister may immediately add terms and conditions to an authorization or amend its terms and conditions if she or he has reasonable grounds to believe that it is necessary to do so to prevent a compromise to human safety or the safety of blood. Urgent circumstances — notice (4) When the Minister adds or amends terms or conditions under subsection (3), the Minister must send the establishment a notice that sets out the reasons for the new or amended terms and conditions and that gives the establishment a reasonable opportunity to be heard concerning them. Removal of terms and conditions (5) The Minister may, by notice in writing, remove a term or condition from an authorization if she or he determines that the term or condition is no longer necessary to prevent a compromise to human safety or the safety of blood.
Blood Regulations — 14
Suspension 14 (1) The Minister may suspend all or part of an authorization in either of the following circumstances: (a) information provided by the establishment under section 6 or 9 proves to be inaccurate or incomplete; or (b) the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that its processes will not compromise human safety and will result in blood that can be determined safe for distribution, by the date specified in the request. Notice (2) Before suspending an authorization, the Minister must send the establishment a notice that (a) sets out the reasons for the proposed suspension and the effective date; (b) if applicable, indicates that the establishment must take corrective action and specifies the date by which it must be taken; and (c) gives the establishment a reasonable opportunity to be heard concerning the suspension. Urgent circumstances (3) Despite subsection (2), the Minister may immediately suspend all or part of an authorization if she or he has reasonable grounds to believe that it is necessary to do so to prevent a compromise to human safety or the safety of blood. Urgent circumstances — notice (4) When the Minister suspends an authorization under subsection (3), the Minister must send the establishment a notice that (a) sets out the reasons for the suspension; and (b) gives the establishment a reasonable opportunity to be heard concerning the suspension.
Blood Regulations — 15
Reinstatement 15 (1) Subject to subsection (2), the Minister must reinstate an authorization if the establishment provides the Minister with sufficient evidence to demonstrate that its processes will not compromise human safety and will result in blood that can be determined safe for distribution. Partial reinstatement (2) If the Minister does not reinstate any part of an authorization that was suspended, the Minister must amend the authorization to remove that part.
Blood Regulations — 16
Cancellation 16 (1) The Minister must cancel an authorization in either of the following circumstances: (a) the establishment fails to provide the Minister with the evidence described in paragraph 14 (1)(b) within a reasonable period after the authorization was suspended; or (b) the establishment’s licence is cancelled under section 29 . Notice (2) When the Minister cancels an authorization, she or he must send the establishment a notice that sets out the reasons for the cancellation and the effective date.
Blood Regulations — 17
Establishment licence required 17 (1) An establishment that processes allogeneic blood — except, subject to subsection (2), blood from a pre-assessed donor — or that imports blood must have an establishment licence to do so. Test labs (2) An establishment that tests blood from a pre-assessed donor for transmissible diseases or disease agents must have an establishment licence to do so.
Blood Regulations — 18
Application for establishment licence 18 (1) An establishment must file with the Minister an application for an establishment licence in the form established by the Minister. The application must be dated and signed by a senior executive officer and contain all of the following information: (a) the applicant’s name and civic address, and its postal address if different; (b) the civic address of each building in which records will be stored; (c) in the case of an establishment that previously conducted its activities under another name, that other name; (d) the name and telephone number, fax number, email address or other means of communication of a person to contact for further information concerning the application; (e) the name and telephone number of a person to contact in an emergency, if different from the person mentioned in paragraph (d); (f) a list of the establishment’s activities; (g) a list of the whole blood and blood components in respect of which the activities are proposed to be conducted; (h) the civic address of every building in which it proposes to conduct its activities and a list of the activities that are proposed to be conducted in each building; (i) the name, civic address and licence number, if any, of any other establishment that it proposes to have conduct any of its activities; (j) sufficient evidence to demonstrate that the establishment can conduct its activities in accordance with its quality management system and the requirements of these Regulations and that its activities will not compromise human safety or the safety of blood; (k) in the case of an importer or an establishment that proposes to have any of its testing conducted by a foreign establishment, the information described in paragraphs (a) and (f) to (j) with respect to every foreign establishment that processes or distributes the blood that they propose to process or import; and (l) in the case of an establishment that proposes to import blood in urgent circumstances, all of the information required by subsection 92 (1). Information on request (2) An establishment must provide the Minister, on written request, with any information that the Minister determines is necessary to complete the Minister’s review of the application, by the date specified in the request.
Blood Regulations — 19
Inspection 19 (1) During the review of an application for an establishment licence, the Minister may inspect the establishment’s facilities and equipment to assess whether the applicant’s activities are conducted in accordance with its proposed authorization and with these Regulations. Information on request (2) An establishment must provide the Minister, on written request, with any information that she or he determines is necessary to complete the inspection, by the date specified in the request.
Blood Regulations — 20
Issuance 20 On completion of the review of an application, the Minister must issue an establishment licence, with or without terms or conditions, if both of the following requirements are met: (a) an authorization has been issued with respect to the blood — except blood from a pre-assessed donor — that is proposed to be processed or imported under the licence; and (b) the Minister determines that the application provides sufficient evidence to demonstrate that issuance of the licence will not compromise human safety or the safety of blood.
Blood Regulations — 21
Refusal 21 The Minister may refuse to issue a licence if she or he determines that any of the information provided by the establishment in its application is inaccurate or incomplete.
Blood Regulations — 22
Changes requiring application to amend licence 22 (1) Before making any change that affects the information provided under any of paragraphs 18 (1)(f) to (i), (k) and (l), the establishment must, subject to paragraph 23 (b), file with the Minister an application to amend the licence. Applications (2) Sections 18 to 21 apply to an application to amend a licence, with any necessary modifications.
Blood Regulations — 23
Administrative changes — notice 23 An establishment must notify the Minister in writing of the following changes: (a) as soon as possible after any change is made to the information provided under any of paragraphs 18 (1)(a) to (e); and (b) within 30 days after the cessation of any licensed activity.
Blood Regulations — 24
Changes requiring amendment of licence by Minister 24 The Minister must amend an establishment licence in any of the following circumstances: (a) an authorization is amended in a way that affects the information provided by the establishment under any of paragraphs 18 (1)(f) to (k); (b) the Minister receives a notice from the establishment under paragraph 23 (a) concerning a change to the information provided under paragraph 18 (1)(a); (c) the Minister receives a notice from the establishment under paragraph 23 (b) that it has ceased one or more but not all of its licensed activities; or (d) an authorization is cancelled, and the cancellation affects the information provided by the establishment under any of paragraphs 18 (1)(f) to (k).