Update to the drug establishment licence application form and process

Drug Establishment Licensing Bulletin 123, January 12, 2022

Health Canada has created a new fillable PDF version of the drug establishment licence (DEL) application form (FRM-0033). For best results, download and fill this form in a PDF reader.

We have also updated the instructions for the form.

The fillable form is designed to be more efficient, reduce errors and minimize delays in processing.

When filling out the new fillable form, remember to follow the Guidance on drug establishment licences (GUI-0002). The guidance includes applications:

• for a new DEL
• to amend a DEL
• to add a Canadian warehouse or alternate sample retention site
• to renew good manufacturing practices evidence for foreign buildings (new evidence required by (NERBY) date)
• to request the re-instatement of a DEL after addressing the situation that caused the suspension
• to request the cancellation of a DEL
• to request the re-activation of a DEL

Email your completed applications to el.applications-le@hc-sc.gc.ca.

Health Canada set the transition period between using the old form and the new fillable form at 6 months. As of July 12, 2022, we will only accept the most current version of FRM-0033.

If you have any questions, please email us at del.questions-leppp@hc-sc.gc.ca.