Drug Establishment License (DEL)

A DEL (Drug Establishment License) governed by Part C, Division 1A of the Food and Drug Regulations—is a mandatory license for any business in Canada involved in fabricating, packaging/labeling, testing, importing, distributing, or wholesaling human or veterinary drugs. “Applicable drugs”- This includes pharmaceutical drugs, APIs, vaccines, biologics, radiopharmaceuticals, narcotics, and cannabis-derived drugs. Regulatory impact
  • No licensable activity may perform without a valid DEL
  • Those operating under a suspended or canceled DEL must cease all licensable actions.
DEL Eligibility requirements
If your company conducts any of the following in Canada—fabricating, packaging, testing, importing, distributing, or wholesaling drugs—must hold a DEL
  • Fabricate: Prepare or preserve a drug for sale.
  • Package/label: Place drugs in containers or apply labels
  • Test: Conduct required quality control testing
  • Import: Bring drugs into Canada for sale
  • Distribute/wholesale: Sell drugs for resale (non-retail)
Exemptions—e.g., packaging by fabricators or importing bulk drugs sold in original containers—but generally, any covered activity without a valid DEL is illegal
Types of DEL Applications
  1. New DEL Application (C.01A.005): First-time applications or reactivation after cancellation
  2. Amendment Application (C.01A.006): To add/remove buildings, activities, drug categories, sterile product status, or update annexes
  3. Annual License Review (ALR, C.01A.009): Due annually before April 1; necessary even for new licenses issued near that date
  4. NERBY (“New Evidence Required By”): A conditional form allowing license renewal with a commitment to provide GMP evidence by a set date
  5. Reinstatement (C.01A.018): To resume activities after a suspension–subject to inspection. Note: if suspended >12 months, license is automatically canceled
  6. Cancellation: Voluntarily request license cancellation via letter or email.
What to Include in Your Application?
Applications must meet Section C.01A.005 specifications:
  • Company info – legal name, contact person, emergency contact details.
  • Domestic building(s) – address, defined activities (fabrication, etc.), drug category, dosage forms, and whether sterile operations occur.
  • Importers – detailed annexes listing foreign buildings, their activities, and alignment with Canadian import scope
  • Drug details – list of APIs, dosage forms, any controlled or narcotic substances.
  • GMP evidence – required for fabricators, importers, and foreign sites. Can incorporate previous inspection reports or certificates, especially under Mutual Recognition Agreements.
Submitting a DEL Application-exempt ALR
FRM-0033
FRM-0033 is the form prescribed by the Minister to submit DEL applications. A complete FRM0033 must be submitted with every application and include the following information:
  • Applicant Information
  • Canadian Building Information
  • Foreign Building Information
Table A
The Table A form is an Annex to the FRM-0033 that must be submitted, in addition to FRM-0033, when submitting an application requesting to:
  • amend the Active Pharmaceutical Ingredient (API) Foreign Building annex of your DEL
  • add an API Foreign Building Annex to your DEL or
  • add an API Foreign Building Annex as part of a New DEL application
ALR application-submission
The Annual License Review (ALR) is a yearly requirement for all active Drug Establishment License (DEL) holders to keep their license valid and up to date.
  • Licensees may request NERBY, delaying GMP evidence submission to a future deadline while maintaining the license.
  • Missing ALR or NERBY deadlines can trigger suspension or final cancellation.
  • It does not require Form FRM-0033.
Approval, Conditions, Suspension, and Cancellation
Upon approval, Health Canada issues a DEL under Section C.01A.008, which may include specific conditions to protect public health. License stewardship includes:
  • Suspension – for GMP breaches, non-disclosure of major facts, or public health risks.
  • Cancellation – if:
  • Suspended for >12 months,
  • Fail to file ALR by April 1,
  • Do not respond to deficiency notices within prescribed timeline

Why Partner with Masuu Global Solutions?

At Masuu Global Solutions, we specialize in guiding pharmaceutical and biotech firms through the DEL. Navigating the complex and highly regulated process of obtaining and maintaining a Drug Establishment Licence (DEL) in Canada can be overwhelming—especially for growing pharmaceutical, biotech, and healthcare companies. At Masuu Global Solutions, we don’t just offer guidance—we become your strategic partner through every step of the DEL journey.

Strategic Application Planning
We work closely with your team to build a strong application from the ground up, ensuring that all your buildings, activities, dosage forms, and drug categories are clearly defined and aligned with Health Canada’s requirements. Whether you’re applying for the first time or amending an existing licence, we streamline the process and eliminate guesswork.
GMP Documentation & Evidence Support
Compiling Good Manufacturing Practices (GMP) evidence can be one of the most time-consuming parts of a DEL submission. We simplify it. Our regulatory experts prepare complete, audit-ready dossiers that meet Health Canada’s expectations—reducing the risk of deficiency notices and speeding up approvals.
Foreign Annex Management
If you’re importing drugs or APIs from outside Canada, each foreign site must be listed and verified. We manage your Foreign Building Annexes end-to-end: from collecting proper GMP documentation and inspection reports to formatting them according to Canadian regulatory standards. You stay compliant across borders—without the hassle.
Ongoing Support: ALRs, Renewals & NERBY

    We provide end-to-end lifecycle support, including:
    • Annual License Review (ALR) preparation and submission
    • NERBY (New Evidence Required By) scheduling and documentation
    • Updates and amendments as your operations evolve
    • Quick action in response to inspection outcomes or scope changes
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