Blood Regulations (SOR/2013-178)

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).

Marginal note: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.

• 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

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.

Marginal note: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.

• 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

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

Establishment Licences

Marginal note: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.

• Marginal note: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.

Marginal note: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).

• Marginal note: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.