Blood Regulations (SOR/2013-178)

Interpretation

Marginal note:Definitions

1 The following definitions apply in these Regulations.

accident

accident means an unexpected event that is not attributable to a deviation from the operating procedures or applicable laws and that could compromise human safety or the safety of blood. (accident)

Act

Act means the Food and Drugs Act. (Loi)

adverse reaction

adverse reaction means an undesirable response that is associated with

• (a) in the case of a donor, the collection of blood; and

• (b) in the case of a recipient, the safety of the transfused blood. (effet indésirable)

allogeneic

allogeneic, in respect of blood or a blood donation, means that the blood is collected from an individual either for transfusion into another individual or for use in the manufacture of a drug for human use. (allogénique)

authorization

authorization, in respect of any blood or process, means an authorization that is issued under section 7. (homologation)

autologous

autologous, in respect of blood or a blood donation, means that the blood is collected from an individual for transfusion into the same individual at a later time. (autologue)

blood

blood means human blood that is collected either for transfusion or for use in the manufacture of a drug for human use, and for greater certainty, it includes whole blood and blood components. (sang)

circular of information

circular of information means a document that describes all of the following in relation to blood:

• (a) the composition and properties of the blood;

• (b) directions for storage and for use; and

• (c) indications for use, contraindications, warnings and a list of possible adverse reactions. (document d’information)

critical

critical, in respect of equipment, supplies and services, means that the equipment, supply or service could, if it does not meet its specifications, compromise human safety or the safety of blood. (essentiel)

designated donation

designated donation means a blood donation that is made by a donor who is selected for medical reasons to make the donation for a specific recipient. (don désigné)

directed donation

directed donation means a blood donation that is made by a donor who is known by the recipient and selected for medical reasons by the recipient’s physician. (don dirigé)

distribute

distribute does not include to transfuse. (distribution)

donation code

donation code means the unique group of numbers, letters or symbols, or combination of any of them, that an establishment assigns to a unit of blood at the time of collection. (code d’identification du don)

donor identification code

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)

donor suitability assessment

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)

error

error means a deviation from the operating procedures or applicable laws that could compromise human safety or the safety of blood. (manquement)

establishment

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)

human safety

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)

medical director

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)

operating procedures

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)

pre-assessed donor

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)

processing

processing means any of the following activities:

• (a) donor suitability assessment;

• (b) collection;

• (c) testing; or

• (d) blood component preparation. (traitement)

safety

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)

serious adverse reaction

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)

standard

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)

transformation

transformation, in respect of blood components, means washing, pooling and irradiation that are performed after blood has been determined safe for transfusion. (transformation)

unexpected adverse reaction

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)

Application

Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Prohibitions

Marginal note: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).

• Marginal note:Exception — pre-assessed donor programs

  (2) Subsection (1) does not apply if the processing is conducted as part of a pre-assessed donor program.

• Marginal note: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.

• Marginal note: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.

• Marginal note:Transformations

  (5) An establishment must not distribute or transfuse blood that has been transformed unless the transformation is conducted by a registered establishment.

• Marginal note: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).

• Marginal note: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.

Authorizations, Establishment Licences and Registrations

Authorizations

Marginal note: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.

• Marginal note:Exception — pre-assessed donor programs

  (2) Subsection (1) does not apply if the processing is conducted as part of a pre-assessed donor program.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Marginal note: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.

Marginal note: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.

Marginal note: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.

• Marginal note: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).