If you’re planning to sell pharmaceutical drugs, disinfectants, or antimicrobial products in Canada, obtaining a Drug Identification Number (DIN) from Health Canada isn’t optional—it’s a regulatory requirement. This unique eight-digit number confirms that your product has passed Health Canada’s review for safety, quality, and efficacy, and is approved for sale across the country.
Whether you’re a manufacturer, private label distributor, or importing brand, the DIN is your product’s legal entry point into the Canadian drug market.
What Is a DIN?
A Drug Identification Number (DIN) is issued by Health Canada to products that qualify as drugs under Canadian law. It authorizes the legal sale of that product in Canada and ensures its inclusion in Health Canada’s Drug Product Database (DPD).
Drugs that require a DIN include:
-
Prescription and over-the-counter (OTC) medications
-
Disinfectants with antimicrobial claims
-
Veterinary drugs
-
Certain natural health products with drug-like actions (e.g., antiseptic hand sanitizers)
Each DIN is associated with details like:
-
Manufacturer or license holder
-
Active ingredients
-
Dosage form, strength, and route of administration
Once approved, this information becomes publicly accessible in the DPD.
Who Needs a DIN?
A DIN is required for any business that manufactures, imports, packages, or labels drugs in Canada. Even if you’re selling an already-approved product under your own brand (private labelling), your version needs its own DIN.
Steps to Apply for a DIN in Canada
1. Confirm your product’s classification
Ensure the product qualifies as a drug under Health Canada’s definition. Misclassification could delay your application or result in rejection.
2. Prepare your application dossier
This must include:
-
A completed Drug Submission Application Form
-
Full product composition and specs
-
Bilingual (English and French) packaging and labels
-
Clinical or scientific data, where required
-
Proof of GMP compliance and valid site licences
3. Submit via CESG
Applications are submitted through the Common Electronic Submissions Gateway. Once received, Health Canada begins its technical and regulatory review.
4. Health Canada’s assessment and DIN issuance
DIN approvals typically take 45 to 90 days. Certain disinfectants or OTC products may qualify for faster reviews under expedited programs.
After approval, your DIN is issued and your product is added to the public Drug Product Database.
Common Application Pitfalls
Many applicants experience avoidable delays due to:
-
Misclassified products
-
Incomplete submissions
-
Missing bilingual labels
-
Lack of GMP evidence or site licence validation
These missteps can significantly slow down your path to market or result in a rejected application.
Why Partner with Quality Smart Solutions?
Getting a DIN approved is more than just paperwork—it’s a technical, evidence-based process. At Quality Smart Solutions, we simplify this process and help you avoid costly errors. Our regulatory team offers complete support from classification to submission, so you can launch confidently.
We assist with:
-
Regulatory strategy and product classification
-
Full DIN application prep and submission
-
Label review and packaging compliance
-
Clinical evidence and GMP documentation
-
Ongoing regulatory maintenance and Health Canada correspondence
FAQs
Do all drugs in Canada require a DIN?
Yes, unless the product qualifies as a natural health product or device.
Can I sell my drug while the DIN is under review?
No. You must wait for official approval before marketing.
Does each product format need a unique DIN?
Yes. Different dosage forms, strengths, or formulations each require their own DIN.
Is a DIN permanent?
It remains valid as long as the product is compliant, actively sold, and the annual regulatory fees are paid.
