Blood Establishment Licensing Application Form and Instructions - (FRM-0354)

Blood Establishment Licence

The Blood Establishment Licensing (BEL) Application Form and Instructions are used by establishments in Canada that conduct activities requiring a licence under the Blood Regulations.

Who is required to hold a BEL?

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

  • processing allogeneic blood, except as part of a pre-assessed donor program;
    • Note: Under the Blood Regulations, "processing" is defined as any of the following activities: donor suitability assessment; collection; testing; or blood component preparation.
  • importing blood; and/or
  • testing blood from a pre-assessed donor.

Additional information regarding a licence can be found within:

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 Licence Application Form and the Frequently Asked Questions - Blood Establishment Licensing and Registration please send a request to, with subject line: "Request for BEL Forms and FAQs".

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

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