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Blood Regulations (SOR/2013-178)

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Regulations are current to 2020-05-17 and last amended on 2015-04-23. Previous Versions

Prohibitions

Marginal note:Allogeneic blood

  •  (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

  •  (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

  •  (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

 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

 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

  •  (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).

Marginal note:Emergency changes

  •  (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.

  • Marginal note: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.

Marginal note:Administrative changes — notice

 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.

Marginal note:Other changes — annual report

  •  (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.

  • Marginal note:Amendment by Minister

    (2) On receipt of the report, the Minister must amend the establishment’s authorization accordingly.

  • Marginal note: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.

  • Marginal note:Application to amend authorization

    (4) On receipt of the notice, the establishment must file an application to amend its authorization

 
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