Drug establishment licences
Health Canada is supporting drug establishment licence holders by providing temporary measures due to COVID-19. For more information, please visit DEL and GMP temporary measures due to COVID-19.
On this page
- What is a drug establishment licence
- Applying for a drug establishment licence
- Drug establishment licence fees
- Drug establishment licence bulletins
- Drug and health products inspections database
- Contact us
What is a drug establishment licence
All Canadian drug establishments must have a drug establishment licence (DEL) to fabricate, package/label, distribute, import, wholesale or test a drug. This is required under Part C, Division 1A of the Food and Drug Regulations (FDR).
For more information on how to comply with Part C, Division 1A of the FDR, please consult:
A DEL is not required for natural health products that are subject to site licensing requirements.
Applying for a drug establishment licence
If you fabricate, package/label, import, distribute, wholesale or test human and/or veterinary drugs, you must apply for and maintain a DEL.
Refer to the following documents for more information:
- Guidance on drug establishment licences (GUI-0002)
- Drug establishment licence application: Form and instructions (FRM-0033)
- Management of applications and performance for drug establishment licences (GUI-0127)
- Guidance document alternate sample retention site guidelines (GUI-0014)
If you are importing or intending to import products from a foreign building located outside Canada, refer to:
Drug establishment licence fees
As a cost-recovery measure for evaluating the compliance of establishments with regulatory requirements, we may apply fees for DEL applications.
For more information, refer to:
For information on drug establishment licence fees, email us at: criu-ufrc@hc-sc.gc.ca.
Drug establishment licence bulletins
Health Canada regularly sends DEL bulletins to inform stakeholders of our regulatory activities, process changes and hot issues.
For more information and posted bulletins, please visit:
Drug and health products inspections database
To verify if a domestic or foreign building has a compliant or non-compliant rating and for more information, consult:
Contact us
For information on drug establishment licensing, email us at: del.questions-leppp@hc-sc.gc.ca.