Blood Regulations

• Guidance Document: Blood Regulations (modified March 8, 2016)
• The Establishment Licence Application Form and Registration Application Form can be obtained by sending an email to blood_sang_questions@hc-sc.gc.ca.

Related documents

• The Inspection Strategy for Blood Establishments (POL-0039) document is intended to provide information on Health Canada's approach to inspections of all blood establishments regulated under the Blood Regulations.
• The guidance document entitled: Risk Classification of Observations made during Inspections of Blood Establishments (GUI-0061) is an administrative tool to inform blood establishments on how observations noted during inspections are classified by Health Canada.
• Blood Regulations - Error or Accident Investigation Preliminary Report Form (FRM-0337) is intended to facilitate the submission of error and accident reports that are required to be submitted to Health Canada within 24 hours, as per section 107 of the Blood Regulations.

Contact Information

If you have any questions or concerns regarding the requirements of the Blood Regulations or its Guidance Document please email them to bgtd.opic@hc-sc.gc.ca

Related Information

• Canada Gazette Part II (2013)
• Harper Government Adopts New Blood Regulations - Rules further strengthen the safety of Canada's blood supply (2013)
• Regulatory Initiatives: Blood and Blood Components (2008-2013)