Blood for transfusion or for use in the manufacture of a drug

On this page

• Who must register or be licensed
• How to apply for an authorization
• How to apply for registration
• How to apply for a blood establishment licence
• Requirement to report an error or accident
• Inspections
• The Blood Regulations

Who must register or be licensed

Blood establishments fall into one or more of three groups based on risk and must have the proper Health Canada approvals for each.

Establishments that:

• process allogeneic blood require an authorization and an Establishment Licence (EL)
• process autologous blood or transform blood or that have a pre-assessed donor program (PADP) require registration
• only store, transport or transfuse blood are not required to have an authorization, EL or registration

Establishments conducting activities from all three categories are required to have an authorization, a licence and a registration.

How to apply for an authorization

The Biologics and Genetic Therapies Directorate at Health Canada is responsible for authorizing blood establishments. For more information, see section 6(1) of the Guidance Document: Blood Regulations.

How to apply for registration

To register, fill in the Blood Establishment Registration Application: Form and Instructions - (FRM-0353).

How to apply for a blood establishment licence

To apply for a licence you must fill in an electronic copy of the Blood Establishment Licence Application Form - (FRM-0354).

Requirement to report an error or accident

Any establishment conducting activities under the Blood Regulations is required to investigate and report errors and accidents to Health Canada.

To file, use the Blood Regulations - Error or Accident Investigation Preliminary Report Form (FRM-0337). Complete all relevant sections and print, date and sign it.

Inspections

Health Canada is the federal authority responsible for the safety of blood in Canada and is authorized to inspect, under section 23 of the Food and Drugs Act.

We conduct inspections to assess compliance with the Act and with the Blood Regulations.

The current Inspection approach for blood establishments (POL-0039) and the Risk Classification of Observations made during Inspections of Blood Establishments (GUI-0061) used during inspections are both publicly available.

The Pre-Inspection Package for Blood Establishments (FRM-0414) provides information and advice on how to comply with the Blood Regulations and the blood inspection process.

To learn more about the blood inspections we conduct, visit the "About blood inspections" page or browse inspections results in the Drug and Health Product Inspection Database.

The Blood Regulations

The Blood Regulations under the Food and Drugs Act (Act) came into force on October 23, 2014. Before this, blood and blood components were regulated under the Food and Drug Regulations.

The Blood Regulations consolidate the specific requirements for blood and its components intended for transfusion or for further manufacturing into human drugs. The Blood Regulations address the safety of blood and human safety. The requirements relate to establishments performing:

• processing
  • donor suitability assessment
  • collection
  • testing, and
  • blood component preparation
• labelling
• storage
• distribution
• transformation, and
• importation

The Guidance Document: Blood Regulations provides the necessary information for blood establishments to comply with the requirements of the Blood Regulations.

The Blood Regulations refer to specific sections of the CSA Group Blood Standard shown in CAN/CSA-Z902-15 - Blood and blood components.