Guide

Processing allogeneic blood, importing blood or testing certain donations: obtain a blood establishment licence

Priority

Blood registration and licensing are not interchangeable. Classify every activity before choosing FRM-0353 or FRM-0354.

Confirm the scope

Classify collection, donor assessment, testing, component preparation, import and pre-assessed donor programs for every site.

Implement quality systems, personnel, procedures, validation, traceability, storage, investigation, recall and regulatory reporting.

Request electronic FRM-0354, complete scope, sites, activities and attestations and attach the required records.

Coordinate inspection, await the licence and manage renewal, amendment, suspension and ongoing duties before changes.

Official sources are linked in the guide. Checked August 30, 2026; confirm current rules, forms and deadlines with the responsible authority.

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