Drug Identification Number (DIN): What It Is and How to Get One in Canada

If you’re planning to sell pharmaceutical drugs or disinfectants in Canada, securing a Drug Identification Number (DIN) from Health Canada is not optional, it’s mandatory. This eight-digit number confirms that your product has been reviewed and authorized for sale under Canadian law.

For pharmaceutical brands, OTC products, or private label distributors, the DIN isn’t just paperwork it’s your gateway to the Canadian market. Here’s what you need to know.

What Is a DIN?

A Drug Identification Number (DIN) is issued by Health Canada to drugs that meet established standards of safety, quality, and efficacy. Once assigned, the DIN serves as a product’s official approval for legal sale and marketing across Canada.

It applies to:

• • Prescription and over-the-counter drugs

• Disinfectants making antimicrobial claims

Each DIN includes key details about the product, such as:

• • Manufacturer identity

  • Active ingredients

• Dosage form, strength, and route of administration

After approval, the product is listed in Health Canada’s Drug Product Database (DPD), making it accessible to healthcare professionals and consumers.

Who Needs a DIN?

A DIN is required if you’re involved in the manufacture, import, packaging, or labelling of most drugs sold in Canada. This includes:

• Prescription drugs and OTC medications

• Radiopharmaceuticals and veterinary drugs

• Certain natural health products with drug like claims (e.g., antimicrobial hand sanitizers)

Even if you’re relabelling under a private brand, the product needs a DIN registered under that name.

The DIN Application Process: Step by Step

1. Confirm product classification
   Before applying, determine if your product qualifies as a drug. Misclassifying it as a natural health product or medical device can lead to rejection or major delays.
2. Prepare your application
   A complete submission includes:

• • Drug Submission Application Form & Product specs and ingredient details

  • Bilingual (English/French) labels and packaging & Clinical data (if applicable)

• Proof of GMP compliance and site licences

3. Submit electronically
   All applications must go through the Common Electronic Submissions Gateway (CESG). Health Canada then begins their technical and regulatory review.
4. Health Canada review and issuance
   Review timelines vary. Basic DIN applications typically take 45–90 days. Some disinfectants and OTCs may qualify for faster evaluation under priority pathways.

Once approved, your DIN is issued and the product appears in the public Drug Product Database.

Avoiding Common DIN Application Mistakes

Many companies face setbacks that could be avoided with proper planning. The most common issues include:

• Incorrect classification or missing data

• Non-compliant bilingual labelling

• Lack of GMP documentation or valid site licences

Delays from these errors can cost your business time, money, and market opportunities.

Why Work with Quality Smart Solutions?

Applying for a DIN isn’t just about filling forms it’s about demonstrating product quality, safety, and regulatory readiness. Our regulatory experts at Quality Smart Solutions manage the DIN process from start to finish, helping you avoid missteps and fast-track your approval.

We support you with:

• Product classification and regulatory strategy

• Full DIN application preparation and submission & Labelling and packaging compliance

• Clinical data and GMP support & Post-market guidance and regulatory maintenance

Our goal is simple: to help you get your product approved and on shelves faster, without compliance risk.

FAQs

Do all drugs in Canada need a DIN?
Yes. Unless your product qualifies as a natural health product or medical device, a DIN is mandatory.

Can I market the product while waiting for approval?
No. Selling or promoting a drug without a DIN is illegal and can lead to fines or product seizures.

Do different formats of the same drug need separate DINs?
Yes. Different dosage forms, strengths, or formulations each require their own DIN.

Is the DIN permanent?
It remains valid as long as the product is compliant and actively sold. Health Canada may cancel a DIN if the product is withdrawn or violates regulations.

Ready to Apply for a DIN?

Don’t let regulatory missteps slow you down. We’ve helped countless businesses secure their Drug Identification Numbers and bring products to market faster with confidence and full compliance.

Learn more about our DIN Application Services | Health Canada