Drug Establishment License (DEL) Registration

Need a Drug Establishment License (DEL) to legally operate your business in Canada? Our team of regulatory experts will assist you in registering your facility for a Drug Establishment License along with licensing your pharmaceutical products and obtaining a Drug Identification Number (DIN).

Otc Establishment License

Drug Establishment License Overview

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

  • Warehousing and storing of drugs are not considered licenseable 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.

Register Your Facility for A Drug Establishment License

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

  • Completing and filing the Drug 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. This includes obtaining a Drug Identification Number (DIN)
  • Ensuring the annual license fee is paid to Health Canada

Frequently Asked Questions

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

 

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.

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