Canada’s new Blood Regulations require the authorization, licensing and registration of establishments that collect blood for transfusion or for use in the manufacture of a drug for human use. The scope of the Blood Regulations applies to human blood that is collected from donors
for the purpose of transfusion;
as a raw material for further manufacture into blood products; and
for the immunization of donors of plasma for further manufacture (e.g., red blood cells for immunization).
The Blood Regulations do not apply to
Cord blood and peripheral blood that are for use in lymphohematopoietic cell transplantation
Blood that is the subject of a clinical trial
Plasma for further manufacture after an establishment distributes the plasma to the blood product fabricator
Blood products, such as plasma derivatives, and blood product manufacturing; examples of blood products include: coagulation factors, immune globulins,
hyperimmune globulins, and albumin
Blood for further manufacture collected outside Canada
Blood that is of a rare phenotype - not available in Canada - and that is imported in accordance with a prescription (a proof of prescription must be provided
at port of entry).
Blood Processing Authorization
An establishment cannot import, distribute or transfuse allogeneic blood unless it is processed by an establishment in accordance with an authorization and determined safe for distribution. An authorization is permission from Health Canada for an establishment to process allogeneic blood: i.e. conduct donor suitability assessments, collect blood from donors, test blood, and prepare blood components. Except for an establishment that only tests blood or processes blood from pre-assessed donors as part of a pre-assessed donor program, an establishment that processes allogeneic blood must have an authorization to do so. An establishment that imports blood must have an authorization to do so, unless the blood is already the subject of another establishment’s authorization. An authorization gives an establishment the authority to process blood by describing the processes related to blood at the establishment; and the blood components prepared using these processes.
All changes require careful assessment as they may be subject to regulatory filings or other compliance requirements (e.g. computer system validation). Regulatory filings include amendment applications for significant changes, notifications for administrative changes and annual reports for other non-significant changes. Significant changes may include the addition of blood or a blood component, changes in process, facility, critical equipment, supplies, services, medical devices, information technology. Changes with minimal potential to have an adverse effect on human safety or the safety of blood do not require regulatory filings (e.g. changes to building security, blood inventory management, transformation activities).
An Establishment License (EL) is a license issued to an establishment in Canada allowing them to conduct activities requiring a license in a building which has been assessed and is compliant with the Blood Regulations and the Authorization. Activities requiring an EL include the processing of allogeneic blood, blood importation or testing including the testing of blood collected in a Pre-Assessed Donor Program. Most establishments that require an EL will also require an authorization which gets issued first. Pre-Assessed Donor Programs that process allogeneic blood do not require an Establishment License but are required to be registered with Health Canada.
An establishment must obtain an Establishment Licence if it intends to conduct any processing activity on behalf of another establishment. If testing is conducted by a foreign establishment on behalf of an establishment in Canada, the testing establishment must be listed on the Establishment License of the establishment in Canada.
Establishments may be inspected prior to the issuance of the Establishment License and, therefore, must be prepared for the possibility of an inspection when filing the application for an Establishment License. An Establishment License issued under the Blood Regulations will not expire. Post EL issuance, regulatory filings may include amendments for significant changes and notifications for administrative changes. If a licensed establishment intends a significant change, like adding an activity to their Establishment License, they must first add the processing or importation activities to their Authorization.
An establishment that processes autologous blood, transforms blood or processes allogeneic blood in a Pre-Assessed Donor Program must be registered. However, registration is not required for an establishment that only tests autologous blood or for an establishment whose only transformation activity is to pool cryoprecipitate.
The establishment who collects autologous blood is responsible for the testing activity whether it is conducted by them or by another establishment on their behalf. Therefore, if another establishment tests on behalf of an establishment who collects autologous blood, the applicant must list them on their application.
Health Canada may inspect establishments prior to and / or after the issuance of a registration number. Post issuance, notifications and amendments may be filed. While an establishment’s registration number never expires, the establishment must renew their statement of compliance every year before April 1st for their registration number to remain valid.
Quality Assurance for All Blood Establishments (even those not requiring Authorization, Establishment License, Registration)
Canada’s Blood Regulations mandates a robustly documented quality management system that encompasses processing, labeling, import, storage, distribution, transformation, personnel, facilities, equipment, supplies, adverse reaction investigation and reporting. All blood establishments require a quality management system, though the requirements may differ with the type of establishment. Some quality requirements even pertain to establishments that do not conduct activities for which an Authorization, an Establishment Licence or a Registration is required.