Health Canada NOC & Drug Identification Number (DIN) – Market Authorisation in the Canadian System

This topic is part of the SG Systems Global regulatory & operations glossary.

Updated December 2025 • GMP, PQS, Health Canada DEL, PQR/APR, QRM, Data Integrity • Regulatory Affairs, QA, CMC, Canadian Sponsors, Supply Chain

Health Canada’s Notice of Compliance (NOC) and Drug Identification Number (DIN) are the twin pillars of market authorisation for prescription and many non-prescription drugs in Canada. The NOC is Health Canada’s formal statement that a drug’s benefits outweigh its risks under specified conditions; the DIN is a unique eight-digit identifier assigned to each authorised drug product, strength and dosage form. Together they define what can be sold, for what use, and under which identity. From a quality and operations standpoint, NOC and DIN status must be reflected in how you formulate, label, release, distribute and monitor your products—not just in what sits in a regulatory database or on a slide deck.

“In Canada, the NOC is the decision, the DIN is the identity, and your QMS is what proves you still deserve both two, five, ten years later.”

1) What a Notice of Compliance (NOC) and DIN Actually Are

A Notice of Compliance is Health Canada’s formal letter indicating that a drug submission (e.g. NDS, SNDS, ANDS) has been reviewed and found acceptable for sale in Canada under defined conditions of use. It is roughly analogous to an FDA approval letter or EMA marketing authorisation decision. A Drug Identification Number (DIN) is an eight-digit number assigned to each authorised drug product that uniquely identifies its manufacturer/sponsor, brand name, active ingredient(s), strength, dosage form and route of administration. The DIN appears on the product label and in Health Canada’s Drug Product Database (DPD). Simplified: NOC says “you may market this product”; DIN says “this is exactly which product we’re talking about.”

2) Legal and Regulatory Context in Canada

The Food and Drugs Act and Food and Drug Regulations set out the legal framework governing drugs in Canada. A drug that requires a DIN must not be sold unless it has been assigned one, and for many products, an NOC is also required to demonstrate that efficacy and safety standards have been met. NOC/DIN status is linked to the approved Product Monograph, labelling, manufacturing sites, specifications and indications. Health Canada’s review covers quality (CMC), non-clinical and clinical elements; ongoing compliance is maintained through GMP oversight, DEL management, post-market surveillance and periodic submission of changes. Failure to keep real-world practices aligned with NOC/DIN conditions can trigger compliance and enforcement action, including delisting or label changes.

3) How NOC and DIN Fit Together in Practice

For most prescription and many non-prescription drugs, the typical sequence is:

• Submission is filed (NDS, SNDS, ANDS, etc.).
• Health Canada reviews quality, safety and efficacy.
• On approval, Health Canada issues an NOC and assigns a DIN to the product.
• The product is listed in the Drug Product Database under that DIN.

Some categories (e.g. certain OTCs, disinfectants, radiopharmaceuticals) have nuances, but the core pattern remains: the DIN is tied to the authorised product configuration, which is in turn anchored by the NOC and supporting dossier. In ERP, labelling and distribution systems, the DIN becomes a primary key for Canadian SKUs. Treating it as a simple catalogue number without linking it to its regulatory meaning is how companies end up with “DIN drift” between systems and regulatory reality.

4) Innovator vs Generic – NOC/DIN Across Product Types

Innovator drugs (New Drug Submissions, NDS) and generics (Abbreviated New Drug Submissions, ANDS) both receive NOCs and DINs, but the underlying evidence differs. Innovators submit full safety and efficacy packages; generics rely on the reference product’s data and demonstrate pharmaceutical equivalence and bioequivalence. In both cases, quality/CMC standards are high, and DINs reflect specific combinations of brand name (or proper name), strength, dosage form and route. Different strengths or dosage forms generally carry different DINs, even if the brand name is shared. For line extensions, reformulations or new strengths, sponsors may require new submissions, additional NOCs and additional or updated DINs, depending on the nature of the change.

5) Quality & CMC – NOC and DIN as More Than Labels

From a CMC and manufacturing perspective, NOC and DIN status must be reflected in:

• Formulation composition (excipients, strengths, polymorphs, critical attributes).
• Manufacturing sites and processes listed in the submission.
• Specifications and test methods (assay, impurities, dissolution, microbiology, etc.).
• Container/closure systems and packaging configurations.

Changes to these elements after approval must be managed through supplements or notifications according to Health Canada guidance. If the “product on the line” deviates from what the NOC/DIN represents (e.g. an unapproved manufacturing site, unapproved excipient, altered process or spec), then the nominal NOC/DIN status is misleading. QA, CMC and Regulatory Affairs need to work together to ensure that global change control, PQR/APR and lifecycle management keep Canada-specific details in sync with reality.

6) NOC/DIN and the Drug Establishment Licence (DEL)

NOC and DIN authorise products; the Drug Establishment Licence (DEL) authorises certain activities and sites (fabrication, packaging/labelling, testing, importing, distributing, wholesaling). These are complementary:

• A product can have an NOC/DIN, but cannot be legally fabricated, imported or tested for Canada by an establishment that lacks appropriate DEL coverage.
• DELs list the foreign buildings importers rely on; these must align with CMC/supply-chain details in submissions and NOC conditions.

From a systems perspective, NOC/DIN and DEL data should be mapped together: each Canadian SKU (DIN) should be associated with the authorised DEL holders and foreign buildings that touch it. Discrepancies between NOC/DIN filings, DEL listings and actual operations are a recurring theme in Health Canada compliance findings.

7) Labelling, Packaging and DIN in the Supply Chain

The DIN must appear on the inner and outer label as required, and labels must match the approved Product Monograph and NOC conditions (name, strengths, indications, warnings, storage, etc.). In the supply chain, the DIN is a key identifier for:

• ERP and inventory management in Canada.
• Hospital and pharmacy systems (ordering, dispensing, reimbursement).
• Provincial formularies and payer lists.

Incorrect or missing DINs on labels, master data or EDI flows can cause reimbursement problems, pharmacy confusion, tender exclusions and regulatory attention. Integration between regulatory data, label content management, ERP and WMS is therefore just as important as getting the CTD right. In a modern QMS, label and master-data change control should treat DIN as a critical attribute rather than a “nice-to-have” field.

8) Lifecycle Management – Post-NOC Changes and DIN Updates

After a product receives an NOC and DIN, sponsors must manage changes through a structured lifecycle process. Types of changes include:

• CMC changes (site, process, formulation, specifications, container/closure).
• Labelling and Product Monograph changes (new safety information, indication changes, dosing updates).
• Administrative changes (company name, sponsor address, brand name changes).

Many of these require supplements or notifications to Health Canada and can affect DIN listings and label content. A robust QRM-driven change-control process should determine the regulatory category and timing of changes and ensure that manufacturing, labelling and master data updates are synchronised with Health Canada approvals. “Shadow” products that have drifted away from their registered state are a frequent source of audit findings and recall risk.

9) NOC/c – Conditional NOCs and Risk Management

In some cases, Health Canada may grant a Notice of Compliance with conditions (NOC/c), typically for serious, life-threatening or severely debilitating diseases where earlier access is justified but the data set is not yet as complete as a standard NOC. NOC/c decisions come with explicit post-market commitments, such as additional clinical trials, enhanced monitoring or CMC commitments. For QA and operations, that means:

• Awareness that the benefit-risk profile is actively being confirmed.
• Higher expectations around PQR/APR, stability and signal detection.
• Closer scrutiny of any quality issues that might intersect with safety or effectiveness concerns.

NOC/c status should be visible in internal risk registers, QRM and management reviews; it is not just a regulatory footnote. Failure to deliver on commitments can lead to label changes, other regulatory action or even withdrawal of the NOC.

10) International Context – How NOC/DIN Interact with Global Approvals

Many products approved in Canada are also approved by FDA, EMA, MHRA, TGA and others. While there is no simple “mutual recognition” of NOCs, Health Canada often relies on information from other NRAs (inspection reports, scientific assessments, emerging safety signals) as part of its risk-based oversight. Conversely, NOC/DIN decisions can influence how other regulators and procurers view a product’s global footprint. For MA holders, the practical message is: Canadian approval must be integrated into a global lifecycle strategy, not managed in isolation. Inconsistent formulations, labels, sites or risk controls across regions are increasingly visible to regulators that share information and inspection outcomes.

11) Digital Systems, Data Integrity and NOC/DIN Governance

Because NOC/DIN status underpins what is supplied to the Canadian market, digital systems must support:

• Accurate product master data with NOC/DIN linkages in ERP and regulatory information management systems.
• Validated MES/eBMR and LIMS for manufacturing and testing records.
• Strong data integrity controls and audit trails for data supporting release and submissions.
• Alignment between regulatory, QA and supply-chain systems on product identifiers (DIN, GTIN, internal code).

In inspections and recalls, Health Canada may sample electronic records supporting NOC/DIN assertions—particularly batch release, testing and complaints—to confirm that real-world execution matches what the authorisation assumes. Weak DI and poor system integration can undermine NOC/DIN credibility even if high-level regulatory paperwork looks correct.

12) Pharmacovigilance, Complaints and Post-Market Surveillance

NOC/DIN status is not a one-time judgment; it is sustained by post-market evidence. Sponsors must operate pharmacovigilance (PV) and complaint-handling systems that capture Canadian data and integrate it with global safety and quality signals. For each DIN, PV and QA should be able to:

• Identify trends in adverse events, device/drug interactions and medication errors.
• Link complaints and quality defects to batches, manufacturing sites and changes.
• Feed findings into label changes, risk-management plans and PSUR/PBRER submissions where applicable.

Health Canada may re-evaluate NOC/DIN status based on emerging safety or quality data. In extreme cases, this can lead to market withdrawals or significant label restrictions. Internally, robust PV and complaint systems are therefore an essential part of “defending the NOC” over the product’s lifecycle.

13) Recalls, Shortages and the Role of the DIN

When recalls or shortages occur, the DIN is a key identifier for communicating with hospitals, pharmacies and the public. Recall notices typically reference:

• Product name and DIN.
• Lot numbers and expiry dates.
• Nature of the defect and risk.

Traceability systems must be able to map DINs to actual batches distributed through Canadian channels. For shortages, Health Canada’s reporting frameworks often use DINs to track impacted products and coordinate mitigation. If a sponsor’s lot-tracking, DIN mapping or traceability systems are weak, managing recalls and shortages becomes slower, more expensive and more reputationally damaging.

14) Common Pitfalls with NOC/DIN Management

Recurring issues include:

• Using a single DIN across formulations or strengths that differ from the authorised configuration.
• Launching “tweaked” formulations or packs without updating submissions and DIN records.
• Failing to update labels and ERP/WMS after NOC amendments or safety-related changes.
• Assuming third-party distributors will “handle” DIN correctness in their systems.
• Not aligning DEL listings and foreign building coverage with the sites actually manufacturing for a given DIN.

Most of these stem from treating NOC/DIN as purely regulatory identifiers rather than as operationally critical master data. Fixing this requires integrated governance across Regulatory, QA, IT and Supply Chain, not just better forms.

15) Implementation Roadmap – Making NOC & DIN a Living Part of the QMS

A practical roadmap for sponsors and MA holders includes:

• Building a central register that maps each DIN to its NOC, Product Monograph, strengths, dosage forms, manufacturing/testing sites and DEL coverage.
• Integrating this register with ERP, label management and serialisation/GTIN systems.
• Embedding NOC/DIN checks into change control, PQR/APR, artwork changes and new supplier or site onboarding.
• Ensuring Canadian-specific data (DIN, language, storage, warnings) are covered in label reviews and electronic masters.
• Training Regulatory, QA, Supply Chain and Commercial teams on what NOC and DIN actually mean in practice—not just what they stand for.

The aim is that any change, incident or inspection question that touches a Canadian product can be traced back to a single, accurate view of its NOC/DIN status, supporting evidence and operational footprint.

16) FAQ

Q1. What is the difference between an NOC and a DIN?
An NOC is Health Canada’s decision that a drug submission is acceptable for sale, while a DIN is the unique eight-digit identifier assigned to a specific authorised drug product. Many drugs require both: the NOC provides the marketing authorisation, and the DIN defines the product identity used in labelling, systems and listings.

Q2. Can a product have a DIN without a Notice of Compliance?
Some product categories have different pathways, but for most new prescription medicines an NOC is part of the process leading to DIN assignment. In general, a DIN alone does not imply full benefit–risk evaluation has been completed in the way it is for NOC-bearing products; sponsors must follow the specific regulatory route for their product type.

Q3. Do natural health products (NHPs) use DINs?
No. NHPs use Natural Product Numbers (NPNs) or DIN-HMs (for homeopathic medicines), which function differently from DINs assigned to conventional drugs. Sponsors should not treat NPNs and DINs as interchangeable; each reflects a distinct regulatory framework and evidence base.

Q4. If we change a manufacturing site or formulation, do we need a new DIN?
Not necessarily, but you may need to file a supplement or notification to Health Canada and update dossiers, labels and internal systems. Some changes (e.g. new strength or dosage form) may require a new DIN; others may be managed under the existing DIN with appropriate regulatory approval. Change-control and regulatory teams must evaluate each case.

Q5. What is a practical first step for tightening our NOC/DIN governance?
Create a consolidated master list of all Canadian products with their NOC number, DIN, associated submissions, manufacturing/testing sites and DEL linkages. Validate this against Health Canada’s Drug Product Database, then integrate the list with ERP, label management and QMS so that future changes automatically trigger NOC/DIN checks and updates.

Related Reading
• Canada-Specific: Health Canada Drug Establishment Licence (DEL) | CFIA SFCR – Food Traceability
• PQS & Lifecycle: Pharmaceutical Quality System (QMS) | PQR/APR | Quality Risk Management (QRM) | Recall Readiness
• Systems & Data: Data Integrity | WMS | MES | LIMS