Blood Establishment Registration Application: Form and Instructions - (FRM-0353)

Blood Establishment Registration

The Blood Establishment Registration (BER) Application Form is used by establishments in Canada that conduct activities requiring a registration under the Blood Regulations.

Who needs to apply for a BER?

A person who wishes to perform any of the following activities requires a BER:

• collection of autologous blood;
• component preparation of autologous blood;
• have a Pre-Assessed Donor Program; and/or
• transformation of blood.

Additional information regarding a registration can be found within:

• the Blood Regulations;
• the Guidance Document: Blood Regulations;
• the Frequently Asked Questions - Blood Establishment Licensing and Registration;
• the Inspection Strategy for Blood Establishments (POL-0039) - summary; and
• Risk Classification of Observations made during Inspections of Blood Establishments (GUI-0061) - Summary

As of October 23, 2014, the Guidance Document: Blood Regulations replaces some of Health Canada's blood regulatory guidance documents and should be read in parallel with the Blood Regulations.

Contact Information

To obtain an electronic copy of the Blood Establishment Registration Application Form and the Frequently Asked Questions - Blood Establishment Licensing and Registration please send a request to blood_sang_questions@hc-sc.gc.ca, with subject line: "Request for BER Form and FAQs".

Any questions about the Blood Establishment Licences or Registrations can be sent to blood_sang_questions@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)