Health Canada has changed how it screens drug establishment licence applications
Drug Establishment Licensing Bulletin 196, October 15, 2026
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Summary of key changes
Health Canada has changed the Drug Establishment Licence (DEL) application review process to reduce red tape and improve efficiencies.
We have combined the separate DEL and Good Manufacturing Practices (GMP) screening steps into a single step.
This change applies only to applications related to foreign buildings that use full GMP evidence as supporting evidence. This includes requests for extending a New Evidence Required By (NERBY) date.
The change will have a slight impact on DEL applicants, especially in terms of GMP evidence submission timing.
The changes do not affect Health Canada's overall DEL application service standards. The standards in GUI-0127 still apply. Health Canada will announce any future changes.
Learn more:
- GMP compliance review: Full GMP evidence paper assessment
- Reviewing DEL applications: Applications and service standards for drug establishment licences (GUI-0127)
What this means for DEL applicants
There will be changes to:
- when to submit GMP evidence
- how to submit GMP evidence to Health Canada
- some of the milestones and notices issued during the review process
Learn more:
When to submit GMP evidence
We still recommend that importers submit GMP evidence at the same time as the DEL application.
However, we can also receive GMP evidence submissions from:
- the foreign building
- a third party acting for the foreign building
As part of the new combined screening step, we will review GMP evidence earlier in the process.
If you send GMP evidence separately from your DEL application, send it as soon as you receive the application number provided in the acknowledgement of application acceptance. Always include the DEL application number in the subject line when submitting evidence.
If we do not have your GMP evidence when we start screening your application, we will send you a screening deficiency notice. This will count as 1 of your 2 chances to meet the GMP evidence requirements. If you do not provide the information requested by the deadline in the final deficiency notice, we will reject your application.
Learn more:
- Pause-the-clock policy (GUI-0127)
- How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)
How to submit GMP evidence to Health Canada
Email your GMP evidence to us with the DEL and application numbers in the subject line.
This applies whether you are submitting evidence:
- in response to a screening deficiency notice
- separately from your DEL application after receiving an application number
Email: foreign.site-etranger@hc-sc.gc.ca
If your evidence is too large to send in 1 email, either:
- Submit your evidence in multiple emails, using the same subject line format and part number, such as:
- Email 1 Subject: Part 1 of 2 – DEL #XXXXXX-X – Application # XXXXX - Renewal of Foreign Building
- Email 2 Subject: Part 2 of 2 – DEL #XXXXXX-X – Application # XXXXX - Renewal of Foreign Building
- Submit your evidence through LiquidFiles
- Fill in the required fields the same way you would in an email.
- If the files are larger than 1 GB (1000MB), submit them in batches.
Changes to timelines and notices
As a result of the combined screening steps, some information in GUI-0127 has changed.
If you send an application for a foreign building using full GMP evidence, including NERBY extension requests:
- within 95 days you will receive a single screening completion notice that combines the former:
- DEL screening completion notice
- GMP screening acceptance notice
- we will no longer send a separate DEL screening completion notice by day 65
If your application for a foreign building is assigned to Stream 3, you will receive one of the following notices within 170 days instead of 140 days:
- GMP compliance notification
- GMP compliance notification of NERBY extension granted
Learn more:
Contact us
Contact us if you have any questions about this DEL bulletin.