Do you need help meeting the March 31st renewal deadline?
Annual License Review
Drug Establishment License (DEL) holders must submit an annual license review (ALR) application before April 1st of each year. This deadline is approaching fast. If you need help with your 2025 ALR contact Dell Tech to discuss submitting your ALR on time.
On January 6th, 2025, the DEL Unit emailed all DEL holders their ALR package. If you are a DEL holder and have not received your ALR you need to contact the DEL Unit right away to request your ALR be re-sent. All ALR questions can be directed to: del.alr-eal.lepp@hc-sc.gc.ca
The ALR is generated by Health Canada using records as of December 2024. Any DEL amendment application received or processed after that date will not be reflected in your ALR application form. The ALR package includes (as applicable depending on the DINs, and API sites listed on your DEL):
- 2025 ALR Instructions
- 2025 ALR Application Form
- 2025 ALR Drug Identification Number (DIN) Annex
- 2025 ALR Table A Annex
On a separate email from the Cost Recovery Invoicing Unit (CRIU), also sent on January 6th, DEL holders would have received:
- Link to DEL Fees
- Small Business attestation
- Fee exemption attestation
- Link to Drug Establishment Licence Fee Calculator
How to maintain you DEL and submit your ALR application
To maintain your DEL your ALR application should contain the following documents:
- The 2025 ALR application form
- The 2025 DIN Annex or DIN Attestation (as applicable)
- The 2025 Table A Annex (if applicable)
- Small Business attestation
- Fee exemption attestation (if applicable)
When the applicable forms and annex(es) have been completed the ALR application must be e-mailed to: del.alr-eal.lepp@hc-sc.gc.ca
In the subject line of the email “ALR Application-DEL# XXXXXX” must be indicated. Send only one copy of completed forms to avoid any delays in having your ALR reviewed.
Within 20 days of receiving your ALR Health Canada will provide an ALR application number to acknowledge receipt of your application. You will be contacted if any deficiencies are identified in the application.
If you need help submitting your DEL ALR Dell Tech can help. Contact us today and make sure you submit the application before the deadline. Your DEL is at risk of being cancelled if the application deadline is missed.
DELL TECH HAS PROVIDED PROFESSIONAL, CONFIDENTIAL CONSULTING SERVICES TO THE SPECIALTY CHEMICAL INDUSTRY IN CANADA, THE USA, EUROPE AND ASIA FOR THE LAST 40 YEARS.
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