Establishment License (EL) Registration

Need an Establishment License to legally operate your business in Canada? Meet Health Canada experts who will assist you in registering your facility for an Establishment License along with annexing foreign sites to Canadian import license holders.

Otc Establishment License

Establishment License Overview

All Canadian drug establishments need to have an Establishment Licence 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.

Register Your Facility for An Establishment License

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 following activities.

  • Confirming your device classification in Canada
  • 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 
  • Getting a Natural Product Number (NPN), or registering your medical device 
  • Ensuring the annual license fee payable to Health Canada
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