Drug Establishment License (DEL) Registration

This is a license that all drug establishments are required to possess to; package, label, import, fabricate, or test a drug according to Health Canada.  It is not required for Natural Health Products as they are subject to site licensing requirements.

All Canadian drug establishments need to have an Establishment License to manufacture, package, label, sell, distribute, wholesale, import a finished drug or bulk process intermediate drug.

Establishment licenses are granted to Canadian-based companies.  Also, fabricating, packaging, labelling, testing, or importing an API (active pharmaceutical ingredient) requires an Establishment License for the respective activity. However, foreign sites that fabricate, package, label drugs must be annexed to a Canadian importer’s Establishment License. Annexing to their license is an attestation of GMP compliance.

• Warehousing and storing of Drugs are not considered licensed activities. They do not require an Establishment License.
• Health Canada charges a fee for the initial registration and an annual fee, thereafter, depending on the activity.
• Health Canada conducts routine inspections of sites that hold an establishment license to verify they are following Good Manufacturing Practices (GMP) as per Division 2 of the Food and Drug Regulations.

Quality Smart Solutions can register your facility for an Establishment License including annexing foreign sites to Canadian import license holders. We help you by performing the following activities.

• Completing and filing the Establishment License application on your behalf
• Verifying that registration applications are submitted accurately as per Health Canada regulations
• Handling product submissions to Health Canada for OTC and prescription pharmaceuticals
• Obtaining a Drug Identification Number (DIN) for drugs and biologics, depending on your product 

Ensuring the annual license fee payable to Health Canada

Health Canada’s current performance standard to process and issue a Drug Esablishment License (DEL) is 250 calendar days.  A “clock” system is used whereby the clock begins when the DEL application meets administrative completeness stage.  Thereafter the clock runs until the review process stage at which time the click is paused. When the deficiencies are resolved the clock starts again.  

Health Canada’s fees to review a drug establishment license as of April 1, 2023 are as follows:

Fabrication – sterile dosage form – $46, 221

Importation – $35,688

Fabrication -non-sterile dosage form – $34, 266

Distribution – $18,251

Wholesaling – $10,630

Packaging/Labelling – $6,681

Testing – $5,514

Building outside Canada (each) – $1,014

These fees are in Canadian dollars.