Drug establishment licences

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:

• Guidance on drug establishment licences (GUI-0002)

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:

• Guidance: How to demonstrate foreign building compliance with drug good manufacturing practices (GUI-0080)

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:

• Fees for examination of an application for an establishment licence

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:

• The drug establishment licensing bulletin

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:

• Drug and health products inspections database

Contact us

For information on drug establishment licensing, email us at: del.questions-leppp@hc-sc.gc.ca.

Related links

• Good manufacturing practices
• Drug good manufacturing practices (GMP) and drug establishment licence (DEL) enforcement policy (POL-0004)
• Good manufacturing practices inspection policy for drug establishments (POL-0011)