Manufacturing, packaging, importing, distributing, wholesaling or testing drugs: obtain the federal establishment licence
Manufacturing, packaging, importing, distributing, wholesaling or testing drugs: obtain the federal establishment licence
A product authorization and an establishment licence are separate. Do not begin a licensable activity until the authorized scope is confirmed.
Confirm the scope
Map every Canadian or foreign building, activity, drug category, dosage form, warehouse and responsible person.
Prepare the information
Establish GMP evidence, inspection records, quality agreements, foreign-site records, emergency contacts and required attestations.
Complete the process
Use the current FRM-0033, choose the correct application type and submit every supporting record through an accepted channel.
Keep follow-up records
Answer deficiency notices, verify the issued scope and manage annual review, amendments, suspension or cancellation before changes.
Drug establishment licence application — Health Canada