Blood Regulations (SOR/2013-178)

Marginal note: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.

• Marginal note: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.

Marginal note: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.

Marginal note: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.

Marginal note: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.

• Marginal note:Applications

  (2) Sections 18 to 21 apply to an application to amend a licence, with any necessary modifications.

Marginal note: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.

Marginal note: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).

Marginal note:New or amended terms and conditions

• 25 (1) The Minister may add terms and conditions to an establishment licence 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 the activities it conducts are in compliance with these Regulations, by the date specified in the request.

• Marginal note:Notice

  (2) Before adding terms or conditions to a licence or amending its terms or conditions, the Minister must send the establishment a notice at least 15 days before the day on which 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 a licence 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 a licence 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:Additional information

26 An establishment must provide the Minister, on written request, with any additional relevant information to demonstrate that the activities it conducts are in compliance with these Regulations, by the date specified in the request.

Marginal note:Suspension

• 27 (1) The Minister may suspend all or part of an establishment licence in any of the following circumstances:

  • (a) information provided by the establishment under section 18 or 22 proves to be inaccurate or incomplete;

  • (b) the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that the activities it conducts are in compliance with these Regulations, by the date specified in the request; or

  • (c) the establishment is not in compliance with these Regulations.

• Marginal note:Notice

  (2) Before suspending a licence, 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 a licence 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 a licence 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

• 28 (1) Subject to subsections (2) and (3), the Minister must reinstate an establishment licence if the establishment provides the Minister with sufficient evidence to demonstrate that it is in compliance with these Regulations.

• Marginal note:Exception — compliance history

  (2) The Minister may refuse to reinstate an establishment’s licence if its compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations.

• Marginal note:Partial reinstatement

  (3) If the Minister does not reinstate any part of a licence that was suspended, the Minister must amend the licence to remove that part.

Marginal note:Cancellation

• 29 (1) The Minister must cancel an establishment licence in any of the following circumstances:

  • (a) the establishment notifies the Minister under paragraph 23(b) that it has ceased all activities under the licence;

  • (b) the establishment fails to provide the Minister with the evidence described in paragraph 27(1)(b) within a reasonable period after the licence was suspended;

  • (c) the establishment’s compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations; or

  • (d) no authorization under which the establishment processes blood remains in effect.

• Marginal note:Notice

  (2) On the cancellation of a licence, the Minister must send the establishment a notice that sets out the reasons for the cancellation and the effective date.

Registration

Marginal note:Requirement to register

• 30 (1) An establishment that processes autologous blood, that transforms blood or that has a pre-assessed donor program must be registered under these Regulations to do so.

• Marginal note:Exceptions

  (2) Subsection (1) does not apply to an establishment that only tests autologous blood or to an establishment whose only transformation activity is to pool cryoprecipitate.

Marginal note:Application for registration

• 31 (1) An establishment must file with the Minister an application for registration in the form established by the Minister that contains all of the following information:

  • (a) the applicant’s name and civic address, and its postal address if different;

  • (b) in the case of an establishment that previously conducted its activities under these Regulations under another name, that other name;

  • (c) 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;

  • (d) the name and telephone number of a person to contact in an emergency, if different from the person mentioned in paragraph (c);

  • (e) a list of the processing activities that the establishment proposes to conduct in respect of autologous blood and a list of the whole blood and blood components that it proposes to process;

  • (f) a list of the transformation activities that the establishment proposes to conduct and a list of all the whole blood and blood components that it proposes to transform;

  • (g) a statement of whether the establishment has a pre-assessed donor program;

  • (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 and civic address of any other establishment that it proposes to have conduct any of its activities; and

  • (j) a statement, dated and signed by a senior executive officer, that certifies both of the following:

    • (i) that the establishment has sufficient evidence to demonstrate that it is in compliance with these Regulations, and

    • (ii) that all of the information in the application is accurate and complete.

• 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.

Marginal note:Registration

• 32 (1) On completion of the 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.

• Marginal note:Refusal

  (2) The Minister may refuse to register an establishment if she or he determines that the information provided by the establishment in its application is incomplete or if she or he has reasonable grounds to believe that issuance of the registration could compromise human safety or the safety of blood.

Marginal note:Changes — notice

33 An establishment must notify the Minister in writing of any change to the information provided under section 31, within 30 days after the day on which the change is made, and in the case of a change to the information provided under any of paragraphs 31(1)(e) to (i), include in the notice another statement described in paragraph 31(1)(j).

Marginal note:Amendment by Minister

34 The Minister may amend an establishment’s registration to remove from it any activity or building 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.