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
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