What Is IDMP (Identification of Medicinal Products)?

IDMP (Identification of Medicinal Products) is a suite of five ISO standards that define a common way to identify and describe medicinal products - their substances, strengths, dose forms, packaging, and the organizations behind them. Its purpose is deceptively simple: to let regulators, manufacturers, and health systems refer to the same medicine in exactly the same terms, so that information about a drug can be exchanged reliably across companies, countries, and computer systems. Pharmacovigilance, supply-chain tracking, and regulatory submissions all depend on everyone meaning the same thing when they name a product - and before IDMP, they frequently did not.

IDMP is not a piece of software or a single database. It is a shared vocabulary and data model, mandated in the EU and adopted internationally, that a pharmaceutical company must implement across the many systems that hold product information. That implementation is, at its heart, a master data exercise - and it is where most of the real difficulty lives.

What IDMP Is

IDMP gives every element of a medicinal product a standardized definition and, where relevant, a controlled identifier. Instead of free-text product names that vary by market and system, IDMP describes a product structurally: the active and inactive substances, the strength expressed in standardized units, the pharmaceutical dose form, the route of administration, the packaging, and the marketing-authorization holder. The result is that a product can be identified unambiguously and matched across datasets - the foundation for reliable safety reporting and cross-border interoperability.

The standards were developed by ISO in response to a real safety need. When an adverse event is reported in one country, regulators must be able to connect it to the exact product involved, wherever else it is sold. That is impossible when each system describes the product in its own words. IDMP is the agreed language that makes the connection possible.

The Five ISO Standards

IDMP is not one standard but a coordinated set, each covering a different facet of a medicinal product:

• ISO 11238 - identification and description of substances (active ingredients and excipients), the most technically demanding domain because it must capture chemical and biological substance identity precisely.
• ISO 11239 - controlled terms for pharmaceutical dose forms, units of presentation, routes of administration, and packaging.
• ISO 11240 - units of measurement, so strengths and quantities are expressed in a standardized, machine-readable way.
• ISO 11615 - the model for regulated medicinal product information, describing the authorized product as a whole.
• ISO 11616 - the model for regulated pharmaceutical product information, the more abstract pharmaceutical product used for scientific comparison across markets.

Together they form a layered model: substances and controlled vocabularies at the base, assembled into pharmaceutical and medicinal product descriptions at the top.

SPOR and the EU Mandate

In the European Union, IDMP is not optional. Commission Implementing Regulation (EU) No 520/2012 (articles 25 and 26) obliges Member States, marketing-authorization holders, and the EMA to use the ISO IDMP standards for exchanging medicinal product information. The EMA operationalizes this through SPOR, a set of master data management services organized into four domains:

• S - Substance Management Services (SMS) - authoritative data on substances.
• P - Product Management Services (PMS) - authoritative data on medicinal products.
• O - Organisation Management Services (OMS) - registered organizations (e.g. authorization holders, manufacturers).
• R - Referential Management Services (RMS) - the controlled vocabularies and lists everything else references.

SPOR is being delivered in phases, and the naming is telling: the EMA explicitly frames IDMP as a master data program. OMS and RMS came first because organizations and reference lists are the shared foundation the substance and product data depend on.

Why IDMP Is a Master Data Problem

The standards are published and stable. What makes IDMP a multi-year program for most pharmaceutical companies is not the specification - it is the state of their own data. A single medicinal product is typically described in several systems that grew up independently:

• the regulatory information management (RIM) system,
• R&D and CMC (chemistry, manufacturing, and controls) systems,
• manufacturing ERP and MES,
• pharmacovigilance and safety databases,
• and the quality management system.

Each holds its own version of the product - different names, internal codes, units, and levels of completeness, maintained by different teams for different purposes. IDMP requires the company to produce one reconciled, standardized description and keep it consistent as the product changes. That is the definition of a master data management problem: a shared entity, fragmented across systems, that must be governed into a single source of truth. The obstacles are the classic ones - inconsistent identifiers, poor data quality, unclear ownership, and no shared map of where the authoritative value for each attribute actually lives.

How Dawiso Fits

To be precise: Dawiso is not a regulatory submission tool and does not submit data to the EMA SPOR services - dedicated RIM and IDMP submission platforms do that. What Dawiso addresses is the master data governance foundation that determines whether an IDMP program succeeds or stalls.

• A map of where product data lives. The data catalog inventories the systems and datasets that hold product, substance, and organization information, so a program can see every place an IDMP attribute is mastered instead of discovering them one crisis at a time.
• Consistent definitions. The business glossary pins down what each IDMP concept means for the organization - "active substance," "strength," "pharmaceutical dose form" - so teams reconcile against one shared definition rather than negotiating per project.
• Data quality and ownership. Dawiso records quality expectations and clear ownership for the attributes that feed IDMP, turning "who is responsible for the authoritative strength value" from an open question into a governed fact.
• Traceability. Interactive lineage shows how a product attribute flows between systems, which is exactly what reconciliation and audit-readiness require.

IDMP is a standard wrapped around a master data reality. The submission tooling handles the standard; governed, well-understood, high-quality master data is what makes the submission possible - and that is where Dawiso contributes.

Conclusion

IDMP is the shared language that lets the world describe a medicine the same way - five ISO standards spanning substances, dose forms, units, and product information, delivered in the EU through the EMA's SPOR master data services and mandated by EU 520/2012. Its purpose is patient safety and interoperability; its difficulty is master data. Companies that treat IDMP as a submission project underestimate it; those that treat it as a master data governance program - governing product data across regulatory, R&D, manufacturing, safety, and quality systems - give themselves a foundation that pays off well beyond the mandate.

Sources

• European Medicines Agency - Data on medicines (ISO IDMP standards): Overview (the five standards, SPOR, and EU 520/2012).
• European Medicines Agency - Substance, product, organisation and referential (SPOR) master data.