Health Canada Drug Establishment Licence (DEL) – Gateway to the Canadian Market

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • GMP, QMS, QRM, Process Validation, PQR, Data Integrity • Regulatory Affairs, QA, Supply Chain, Operations, Responsible Persons

Health Canada’s Drug Establishment Licence (DEL) is the regulatory authorisation that allows a company to conduct certain drug-related activities for the Canadian market—such as fabricating (manufacturing), packaging/labelling, testing, importing, distributing or wholesaling. A DEL is issued only after Health Canada is satisfied that the establishment meets Canadian GMP requirements for those activities. In practical terms, the DEL system is how Health Canada links GMP oversight to supply-chain nodes: if you touch a prescription or certain non-prescription drugs in ways defined by the Food and Drugs Act, you need a DEL, and you need to keep it. For global firms, DEL status tells you who Health Canada views as responsible nodes in the chain—not just who sells product on paper.

“If you’re on the label for Canada, Health Canada wants to know who’s really touching the product—and the DEL is how they make you prove it.”

1) What a Drug Establishment Licence (DEL) Actually Is

A DEL is a formal licence issued by Health Canada authorising specific establishments to perform defined activities on human and veterinary drugs. It lists the establishment name and address, the authorised activities (e.g. fabrication, packaging/labelling, testing, importing, distributing, wholesaling), dosage-form categories, and, for importers, the foreign buildings they rely on. It is granted based on evidence of GMP compliance—often including on-site inspections or recognition of inspections by trusted regulators—and is subject to ongoing oversight. Without a DEL, those activities cannot legally be performed for the Canadian drug market, regardless of marketing authorisation status.

2) Activities That Trigger DEL Requirements

The DEL framework applies to a defined set of activities in relation to drugs: fabrication (manufacturing), packaging/labelling, testing (finished product and sometimes APIs), importing (bringing drugs into Canada for sale), distributing and wholesaling. Some activities and product types have exemptions (for example, certain small-scale healthcare facility operations or low-risk products), but the default assumption for commercial operations is that a DEL is required. Importers are a special focus: a Canadian importer must hold a DEL and is responsible for ensuring that every foreign building on its licence complies with Canadian GMP, even if those buildings also supply other markets.

3) DEL vs Marketing Authorisation – Two Different Permissions

A DEL does not replace marketing authorisation (a Notice of Compliance plus Drug Identification Number, or other authorisation). Marketing authorisation makes it legal to sell a particular product in Canada; the DEL makes it legal for specific establishments to perform defined GMP activities on drugs destined for that market. An MA holder may or may not hold a DEL, depending on whether they perform activities like importing, fabrication or testing. In practice, Canadian and global sponsors must ensure both sides are covered: the product has an MA, and all entities performing DEL-triggering activities are appropriately licenced and controlled.

4) How Health Canada Uses DELs in GMP Oversight

DELs are central to Health Canada’s GMP oversight model. They define who falls under Health Canada inspection and surveillance for each activity and dosage form. Health Canada can suspend, amend or cancel a DEL if GMP compliance fails, effectively cutting off that establishment’s ability to support the Canadian market. DEL information is also used for risk-based inspection planning, recall coordination and enforcement actions. For global firms, being “on the DEL” makes you visible to Health Canada; trying to stay in the background as a “silent” service provider is increasingly unrealistic and risky.

5) Domestic vs Foreign Buildings and Mutual Recognition

For domestic sites, Health Canada inspects establishments directly under Canadian GMP guidance. For foreign buildings listed on a Canadian importer’s DEL, Health Canada may inspect directly or rely on trusted foreign regulatory partners under mutual recognition or work-sharing arrangements. However, the Canadian importer remains responsible for ensuring those foreign buildings meet Canadian GMP expectations. DEL applications and maintenance files must list foreign buildings and their supervisory authorities, and importers must monitor their status. A loss of GMP recognition for a foreign building can impact the importer’s DEL and supply continuity.

6) GMP Expectations Under the DEL Framework

GMP under the DEL framework is largely aligned with international norms (PIC/S, ICH, FDA/EU). Health Canada expects a robust PQS aligned with ICH Q10 principles, adequate resources and independence for QA, appropriate premises and equipment, validated processes and analytical methods, qualified suppliers and contractors, and reliable documentation. Inspectors will scrutinise process validation, cleaning validation, PQR/APR, deviations, CAPA, and integration of risk management. For biologics and sterile products, expectations align closely with EU Annex 1 and WHO GMP thinking around contamination control strategies and lifecycle validation.

7) DEL Applications, Amendments and Renewals

To obtain a DEL, establishments must submit an application detailing their activities, dosage forms, buildings, quality systems and supporting GMP evidence. Health Canada reviews the application and may perform inspections before granting the licence. DELs must then be maintained: establishments must notify Health Canada of changes (e.g. new activities, new dosage forms, new buildings, new foreign suppliers) and request amendments. There are also renewal and fee-payment requirements at defined intervals. Failing to update DEL information when reality changes—especially for importers and foreign buildings—is a common compliance gap and a red flag in inspections.

8) Inspections and Risk-Based Oversight

DEL holders are subject to periodic GMP inspections, with frequency determined by risk: product type, activity, history, prior findings, and other signals. High-risk activities (sterile injectables, biologics, complex non-steriles) and critical nodes (importers, contract labs) may see more frequent or intensive inspections. Health Canada inspectors examine documentation, facilities, processes and electronic systems, and they expect DEL listings to match reality: the activities being performed, the products handled, and the foreign buildings relied on. Discrepancies between the DEL, the dossier and actual practice can drive significant observations, even when day-to-day manufacturing quality is technically sound.

9) Data Integrity and Computerised Systems for DEL Holders

DEL holders must ensure that record-keeping and computerised systems comply with modern data integrity expectations. That includes validated MES/eBMR, LIMS, ERP and QMS platforms, controlled user access and roles, meaningful audit trails, and governance over spreadsheets and local tools. Health Canada often coordinates its DI expectations with other regulators, so DI-related weaknesses identified by EMA, FDA or MHRA may attract attention in Canadian inspections as well. DEL holders must treat electronic and paper records as part of a single, coherent control environment.

10) Importers and the Foreign Building Concept

Importers occupy a special position in the DEL system. A Canadian importer must hold a DEL that lists the foreign buildings from which it imports. It is responsible for ensuring those foreign sites meet Canadian GMP and for taking action if their compliance status changes. This requires robust supplier qualification, supplier monitoring, quality agreements, and integration of foreign inspection reports into risk assessments. If a foreign building loses its authorisation or fails an inspection, the importer’s DEL—and therefore product supply—can be impacted quickly.

11) DEL and Contract Manufacturing/Testing

When contract manufacturers or labs are involved, their roles must be reflected in DELs and supported by robust technical quality agreements. If a CMO fabricates or packages drug for the Canadian market, it will typically need a DEL (domestic or foreign building listing). If a contract lab performs QC release testing, its activity must also be covered. Sponsors and MA holders must ensure that DEL status, responsibilities and controls are clear and that QMS processes (change control, deviations, CAPA, PQR) flow across organisational boundaries. Health Canada sees the DEL network as a connected system; opaque or missing links are a warning sign.

12) Complaints, Recalls and PQR in the DEL Context

DEL holders must operate effective complaint-handling and recall systems for drugs distributed in Canada. That includes documenting, investigating and trending complaints, conducting mock recalls, and maintaining up-to-date distribution records for traceability. PQR/APR processes should integrate Canadian-specific data—stability, complaints, deviations, returns—into a global view of product performance. For Health Canada, an effective PQR that includes Canadian experience is evidence that the DEL holder is using its licence responsibly, not just fulfilling a legal formality.

13) Enforcement, Suspensions and the Cost of Losing a DEL

When significant GMP issues arise, Health Canada can amend, suspend or cancel DELs partially or in full—for example, restricting certain activities, dosage forms or sites. This can have immediate supply-chain implications: importers may be barred from bringing in product, fabricators may need to halt production, and wholesalers may need to quarantine stock. Restoring a DEL typically requires extensive remediation, inspections and evidence of sustainable change. For companies with significant Canadian business, DEL loss is therefore both a compliance and a financial risk; it should be treated in risk registers on par with major EU/FDA enforcement actions.

14) DELs and Mutual Recognition / International Cooperation

Health Canada participates in mutual recognition and cooperation frameworks (e.g. with EMA and some other NRAs) under which foreign GMP inspections may be recognised to reduce duplication. However, mutual recognition is not a blanket waiver; Health Canada still uses the DEL system to define who is responsible and to ensure that recognised inspections cover the right scope and sites. For global manufacturers, this can create efficiencies—fewer overlapping inspections—but does not remove the need for strong PQS, DI and risk management. A site that is marginal under EU GMP will not automatically satisfy Health Canada just because an MRA exists.

15) Implementation Roadmap – Becoming and Staying DEL-Ready

For organisations newly entering the Canadian market, a pragmatic roadmap includes: mapping all activities that trigger DEL requirements; deciding which entities (internal and external) will hold DELs; performing a gap analysis against Canadian GMP and Health Canada guidances; strengthening PQS, validation and data integrity controls; and building a robust importer/foreign-building oversight model. For existing DEL holders, continuous improvement means aligning DEL scope with reality, integrating Canadian data into global PQR and risk processes, and using inspection feedback to harden systems—not just to patch specific findings. The goal is to make “DEL readiness” indistinguishable from “GMP maturity,” so Canada becomes another proof point rather than a special project.

16) FAQ

Q1. Does every company selling drugs in Canada need a DEL?
No. Only establishments performing specific GMP-relevant activities—fabrication, packaging/labelling, testing, importing, distributing or wholesaling—require a DEL. Some activities and low-risk products are exempt. However, in most commercial supply chains at least one Canadian entity (often the importer) must hold a DEL.

Q2. Is a DEL the same as marketing authorisation?
No. Marketing authorisation (e.g. a Notice of Compliance and DIN) approves a specific product for sale in Canada. A DEL licences establishments to perform certain activities on drugs for the Canadian market. Many companies need both, but they serve different regulatory purposes.

Q3. Do foreign manufacturers need their own DEL?
Foreign buildings generally do not hold DELs directly, but they are listed on the DEL of the Canadian importer. They may still be inspected by Health Canada or assessed via mutual recognition. The importer remains responsible for their GMP compliance in the Canadian context.

Q4. How does Health Canada use mutual recognition in GMP oversight?
Under MRAs, Health Canada may rely on inspection reports from trusted foreign regulators for some GMP decisions. However, it still manages DELs, sets Canadian GMP expectations and can inspect directly where needed, particularly for higher-risk products or concerning histories.

Q5. What is a practical first step for a company planning to import drugs into Canada?
Identify who will act as the Canadian importer of record, map all foreign buildings involved, and perform a GMP/QMS gap analysis against Health Canada expectations. Use that analysis to structure DEL applications, quality agreements and oversight mechanisms before the first dossier is filed.

Related Reading
• Core GMP & QMS: GMP / cGMP | Quality Management System (QMS) | PIC/S PE009
• Risk & Validation: Quality Risk Management (QRM) | Process Validation | CPV
• Systems & Data: Data Integrity | CSV | GAMP 5 | MES | LIMS
• Supply Chain & Oversight: Supplier Qualification | Quality Agreements | Traceability | Mock Recall