ANDS/DIN FILING (HEALTH CANADA)

ANDS/DIN FILING : Health Canada mandates an 8-digit Drug Identification Number (DIN) for all dosage forms of drugs sold in Canada.

It identifies the:
  • Manufacturer
  • Brand name
  • Medicinal ingredient(s) & strength
  • Dosage form
  • Route of administration

DIN assigned to a drug is unique and serves as a tool to help in the post-market activities of products on the market, such as product identification and verification by health care professionals, recall of products, inspections, and quality monitoring.

While the authorization of a drug includes the issuance of a DIN to the manufacturer, the DIN is the property of Health Canada.

“Applicable drugs”- over the counter (OTC), human, and veterinary drugs

Purpose and scope

Assists manufacturers with regulatory obligations, including:
  • Clarify regulatory compliance expectations
  • Outline which notifications manufacturers must submit market entry, dormancy, discontinuation, and cancellation
  • Provide step‑by‑step instructions on submitting a DIN application or notification
  • Support consistent implementation, while allowing flexibility when justified

Applying for a DIN Filing

DINs are assigned at the time of drug-market entry. For new drugs, a new drug submission   (Division 8) automatically includes the DIN application. For non‑Division 8 products (e.g., OTC,  generics), a standalone DIN submission is required.

Required materials:
  • Completed HC/SC 3011 application form, with labels and prescribing info
  • DIN Submission Certification forms (e.g., Appendix C or D)
  • Product‑type‑specific data (formulation, manufacturing, packaging, stability, safety/efficacy evidence)
  • Administrative details as outlined in section 6.10

Post‑DIN Obligations

Once a DIN is issued, the responsibilities don’t end. The guidance outlines these critical obligations:
  • Market Notification: Inform Health Canada upon launch
  • 12‑Month Dormant Status: If no sales occur within 12 months, a notice is required within 30 days (and data must be included in the annual notification)
  • Discontinuation of Sale: Must notify HC if sales cease after being active or dormant
  • Annual Review: Submit a notification confirming all product information remains accurate before October 1 each year per C.01.014.5

Labeling & Product Differentiation

Labels must be designed to meet stringent regulatory requirements to qualify for DIN issuance.
  • Label Details According to Food and Drug Regulations (Part C.04), DIN labels must include brand name, proper/commercial name, quantity, potency, lot number, expiration date, directions for use, holder’s name and address, and storage information.
  • Unique Product Characteristics A DIN is specific to a unique combination of attributes—any change, such as concentration or dosage form, requires a new DIN submission.

Post-DIN Lifecycle: Market Notifications & Dormancy

Issuing a DIN isn’t the end—it’s the beginning of compliance obligations throughout a product’s lifecycle.
  • Market Notification Once the drug is available in Canada, applicants must submit a market notification (via Drug Notification Form, DNF) to inform Health Canada
  • Dormant Status Reporting Failure to sell a drug in 12 consecutive months triggers the need for a “12‑months without sale” notification within 30 days of the deadline. This updates the product’s status in the Drug Product Database
  • If sales resume post‑dormancy, another notification must be issued to reflect the updated status
  • Discontinuation Reporting A formal notification is required when a product is permanently discontinued.

DIN Cancellation & Reassignment

DINs can be revoked or reassigned under specific circumstances, each requiring action from the manufacturer. Grounds for Cancellation DINs may be cancelled for:
  • Emergent safety or efficacy concerns
  • Failure to submit annual drug notifications
  • Determination that the product is not a drug
  • Transition under the Biocides Regulations
Manufacturer Obligations Post-Cancellation

The guidance outlines steps manufacturers must take after a DIN is cancelled—such as  updating labels or removing from market

DIN Reassignment

In certain cases, a cancelled DIN may be reassigned—but it requires a formal request and    Health Canada approval.

Export Considerations

DIN procedure also impacts products intended for export from Canada.

  • Exports Without Section 37 For exported products not intended for use in Canada, no DIN is needed, though other regulatory requirements may apply.
  • Exports Invoking Section 37 Products intended for return to Canadian inventory later may qualify under Section 37 exemptions—applicants must follow additional documentation and notification procedures

our mission revolves around empowering pharmaceutical innovators to bring safe, effective, and compliant products to market. A cornerstone of this process in Canada is understanding and adhering to the Drug Identification Number (DIN) requirements. Health Canada’s “Guidance Document: Regulatory Requirements for DINs” (latest update February 18, 2025) offers a comprehensive framework for applicants like us to successfully obtain and maintain DINs.

Adhering to these requirements we ensure:
  1. Regulatory compliance – avoiding administrative delay or risk of cancellation
  2. Market readiness – enabling timely drug launch
  3. Ongoing traceability – DINs help regulators manage recalls, audits, and safety monitoring

Frequently Asked Questions

A Drug Identification Number (DIN) is an 8-digit number assigned by Health Canada to identify drugs authorized for sale in Canada. It identifies key product characteristics such as the manufacturer, brand name, medicinal ingredient(s), strength, dosage form, and route of administration.

DIN requirements apply to applicable human and veterinary drugs, including many over-the-counter (OTC) and prescription products. A DIN provides a unique identifier that supports product identification, regulatory oversight, recalls, inspections, and post-market quality monitoring.

A DIN is assigned as part of the drug market authorization process. For new drugs submitted under Division 8, the DIN application is included with the New Drug Submission (NDS). For applicable non-Division 8 products, such as certain OTC and generic drugs, a standalone DIN submission may be required.

Depending on the product and submission pathway, the application may include the HC/SC 3011 application form, applicable DIN Submission Certification forms, labels, prescribing information, formulation and manufacturing information, packaging details, stability data, and relevant safety and efficacy information.

DIN-related labels must comply with applicable requirements under the Food and Drug Regulations. Product information can include the brand/proper name, quantity, potency, lot number, expiry date, directions for use, DIN holder’s name and address, and storage conditions, as applicable.

A DIN identifies a specific combination of product characteristics. Changes such as medicinal ingredient strength, dosage form, or other characteristics that create a different product may require a new DIN submission. The applicable Health Canada requirements should be assessed for each proposed change.

Obtaining a DIN is only the beginning of the product’s regulatory lifecycle. Manufacturers may need to notify Health Canada when the product is launched, becomes dormant, resumes sale, or is permanently discontinued, using the applicable notification process and forms.

If a product remains without sales for the applicable 12-month period, the manufacturer may need to submit a 12-months-without-sale notification within the prescribed timeframe. If sales subsequently resume, the appropriate notification must also be submitted to update the product’s status.

A DIN may be cancelled for reasons such as safety or efficacy concerns, failure to meet applicable notification requirements, or a determination that the product no longer meets the definition of a drug. In certain circumstances, a cancelled DIN may be reassigned following a formal request and Health Canada approval.

DIN holders have ongoing responsibilities to keep Health Canada informed about their products. An annual notification is required to confirm that applicable product information remains accurate, with the provided requirements specifying submission before October 1 each year.

Export requirements depend on how the product is intended to be used and whether it is intended for the Canadian market. Certain products exported without being intended for use in Canada may not require a DIN, while products falling under applicable Section 37 provisions may have additional requirements.

Masuu Global supports pharmaceutical companies with DIN strategy, application preparation, documentation, labeling review, market notifications, lifecycle management, and regulatory compliance. Our support helps companies achieve regulatory readiness, timely market entry, and ongoing product traceability throughout the Canadian product lifecycle.

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