Identification of Medicinal Products (IDMP)
What is IDMP?
Identification of Medicinal Products (IDMP) is a suite of five ISO standards that define how to uniquely identify and describe medicinal products across their lifecycle.
Mandated by the European Medicines Agency (EMA) and aligned internationally, IDMP enables consistent, unambiguous communication of product information between regulators, manufacturers, healthcare systems, and other stakeholders.
By establishing a standardised data model for substances, dose forms, units, and product characteristics, IDMP supports global pharmacovigilance, regulatory submissions, labeling, and supply chain traceability.
Why it Matters in Pharma Today
- Regulatory compliance — EMA requires IDMP alignment for submissions via its SPOR master data services; other agencies are evaluating adoption.
- Data harmonisation — Eliminates inconsistencies in product identifiers and descriptions across systems and geographies.
- Safety signal detection — Enhances pharmacovigilance by enabling accurate aggregation of adverse event data linked to specific products.
- Automation & reuse — Structured, standardised product data can be reused in labeling (CCDS, SmPC, USPI, ePI), eCTD 4.0 submissions, and manufacturing systems without manual re-entry.
Global Landscape
| Region/Body | Governing Entity | Adoption Status / Timeline |
| European Union (EU) | EMA | IDMP mandatory for product data submissions; integrated with SPOR. |
| United States (US) | FDA | Exploring alignment with IDMP for structured product labeling; no mandate yet. |
| Japan | PMDA | Monitoring EMA implementation; early alignment in data models. |
| ISO | ISO/TC 215 | Maintains IDMP standards (ISO 11238, 11239, 11240, 11615, 11616). |
| HL7 | HL7 International | Publishes FHIR implementation guides for IDMP. |
The Five IDMP Standards
- ISO 11238 — Substances
- ISO 11239 — Pharmaceutical Dose Forms, Units of Presentation, Routes of Administration, Packaging
- ISO 11240 — Units of Measurement
- ISO 11615 — Medicinal Products
- ISO 11616 — Pharmaceutical Products
How IDMP Works in a Component-Based Authoring Model
Define product attributes — Capture substance, dose form, unit, and packaging details as per ISO standards.
Govern — Validate data against SPOR reference datasets and internal quality rules.
Link — Map each IDMP attribute to metadata fields in component-based authoring systems.
Publish — Reuse harmonised product data across labeling, regulatory submissions, and manufacturing documentation.
Update — When an IDMP attribute changes (e.g., a new dosage form), propagate updates automatically to all dependent documents and data packages.
Example: IDMP in Practice
- Substance change (ISO 11238) → automatically updates SmPC Section 2, CCDS safety profile, and ePI product composition field.
- Route of administration change (ISO 11239) → triggers updates in patient information leaflets and structured product labeling in all affected regions.