Drug establishment licence in Canada and MDEL differences
A Canadian drug establishment licence covers specified drug activities and sites. Learn who needs a DEL, how to apply and how to check a supplier.
A Canadian drug establishment licence (DEL) authorizes specified drug activities: fabrication, packaging/labelling, testing, importing, regulated distribution and wholesaling. It must cover the relevant buildings, activities and drug categories, including sterile operations where required. Regulatory definitions and exemptions determine whether you need a DEL. Health Canada's DEL guidance explains the scope.
A medical device establishment licence (MDEL) belongs to a separate framework. If your company handles both drugs and devices, assess each business activity under the applicable rules. Neither licence should be treated as blanket permission for every product or operation. See the MDEL guidance.
Who needs a drug establishment licence?
Start with the work your company performs, rather than its job title or commercial description. The Food and Drug Regulations require authorization for six activities. Health Canada's guidance explains their regulatory meanings:
- Fabrication means preparing and preserving a drug for sale.
- Packaging/labelling is a separate licensable activity.
- Testing concerns tests and examinations required under the good manufacturing practices (GMP) provisions, rather than every laboratory analysis.
- Importing concerns drugs brought into Canada for sale.
- Distribution includes applicable drug identification number (DIN) holders selling under their own name or controlled mark.
- Wholesaling is a defined regulatory activity. It does not mean every non-retail transaction automatically requires a DEL.
Apply those definitions before deciding whether a licence is needed. GUI-0002, Health Canada's DEL guidance, explains the boundaries and exceptions, including those affecting active pharmaceutical ingredients (APIs).
Third-party GMP testing laboratories generally need testing authorization. There is a testing exception for an already licensed fabricator, packager/labeller, importer or qualifying distributor. Do not extend that exception to every DEL holder. Check subsection C.01A.004(2) against the laboratory's role.
Which activities are exempt?
Storage alone and transportation alone are not licensable activities. However, a DEL holder must still identify applicable Canadian storage buildings. A storage-only exemption does not remove those obligations. GUI-0002 distinguishes the activity from the licence holder's building requirements.
Over-the-counter status is not a blanket exemption either. Certain OTC or unscheduled finished-dose products are exempt from wholesaling requirements. That does not automatically exempt their fabrication or importation. Natural health products use a separate site-licensing framework, as the same guidance explains.
What must your DEL cover?
Check each Canadian building against its authorized activities, drug categories and sterile operations. For importing, the relevant foreign fabrication, packaging/labelling and testing buildings must appear on the appropriate annexes. A supplier's licence number alone cannot establish that its authorized scope matches your proposed work. Use GUI-0002 for the building and annex requirements.
Make that comparison before qualifying a supplier. Ask for the current licence and relevant annexes, then match the listed scope to the work you intend to assign. For an importer, include the foreign buildings involved rather than checking only the Canadian address. Establishment licensing and product authorization are separate checks.
How to apply for a DEL
Use the current FRM-0033 application instructions. Organize the application around the actual operations:
- Identify the activities, buildings, drug categories and sterile operations requiring authorization.
- Complete FRM-0033 with the company and Canadian-building details.
- Add applicable foreign-building information and GMP evidence. Include Table A when adding or amending the API Foreign Building Annex.
- Identify the relevant warehouses and alternate sample-retention sites.
- Submit through the route in the current instructions. Obtain authorization before starting licensable activities.
Table A is specific to the API Foreign Building Annex. For other foreign-building changes, follow the applicable sections of the current instructions rather than assuming the same attachments apply.
For Canadian buildings, domestic GMP evidence is not ordinarily supplied with the initial application. Health Canada requests it during processing and may inspect. GUI-0002 explains this process.
For foreign sites, consult GUI-0080. Its July 2025 update covers foreign-building evidence and importer responsibilities for finished dosage forms, APIs and intermediates. Use the live FRM-0033 instructions for submission contacts instead of relying on an old email address.
Annual review and the foreign-building screening change
DEL holders whose licences are not suspended must apply for annual review before April 1 each year. Use the annual review package, not FRM-0033, for that review. These requirements appear in C.01A.009 and GUI-0002.
If the required application is not submitted, the Minister must cancel the DEL under C.01A.018.1. Treat annual review as a compliance deadline, not optional licence housekeeping.
Health Canada also changed foreign-building application screening in October 2026. It combined DEL and GMP screening for foreign-building applications supported by full GMP evidence. The change did not alter overall DEL application service standards. DEL Bulletin 196 explains the change. Screening completion is not a promise that a licence will be issued by that point.
DEL versus MDEL
The similar names cover different regulatory functions:
| Authorization | Main purpose |
|---|---|
| DEL | Specified drug activities at the authorized buildings and within the licence's scope |
| MDEL | Medical-device importing and distribution, including applicable Class I manufacturers distributing their own devices |
| Medical device licence (MDL) | Separate product licence for Class II, III and IV devices |
The distinctions come from DEL guidance and MDEL guidance. An MDEL does not approve specific devices. A device business must distinguish its establishment activities from the product licences required for the devices it sells.
MDEL exemptions depend on the establishment's role. Qualifying retailers, health-care facilities and dispensers are exempt. Class I manufacturers selling solely through an MDEL holder also have an exemption. Specified manufacturers selling only their own licensed Class II-IV devices have exemptions too. Check the guidance rather than assuming all manufacturers are exempt.
A storage-only device warehouse may be exempt, but buying, selling or consigning devices changes the analysis. Review those activities before relying on a warehouse exemption. The MDEL guidance sets out the relevant distinctions. Physical storage and commercial distribution should not be treated as interchangeable activities.
MDEL applications use FRM-0292. They require establishment details, activities, device classes, manufacturers and senior-official attestations about documented procedures. These include distribution records, complaints and recalls. See Health Canada's MDEL application instructions.
MDEL holders whose licences are not suspended must also apply for annual review before April 1, even when nothing changed. Failure to submit leads to cancellation. After cancellation, a new MDEL is needed before resuming licensable activities. See section 46.1 and the application instructions.
How to check a company's licence
DEL database and supplier checks
Health Canada's Drug and Health Products Inspections Database (DHPID) replaces the old DEL live listing. However, on November 5, 2026, its official landing page reported a temporary outage because of cybersecurity concerns. It directed users to contact Health Canada for inspection or related information.
An inaccessible database does not mean a company is unlicensed. During the outage, request the supplier's current DEL and relevant annexes. Compare the activity, drug category, sterile authorization and buildings with your intended work using GUI-0002. Seek Health Canada confirmation where necessary.
MDEL listing and device product checks
The official MDEL listing lists active licences only. Search by licence number, company ID, company name, activity or location. The listing does not approve specific devices or show every product covered by an establishment licence.
For a Class II, III or IV device's product licence, use the separate Medical Devices Active Licence Listing (MDALL). Keep the establishment check separate from the product check.
RegAffairs AI's answer on Canadian establishment licensing links to cited regulatory provisions, not live company-licence status.