IDMP — Identification of Medicinal Products

A passport system for medicines

IDMP (Identification of Medicinal Products) is a suite of ISO standards that together give every medicinal product a globally unambiguous identity — essential for pharmacovigilance, recalls and cross-border drug safety. The ISO documents themselves are paywalled, and regulators (the EMA, FDA) drive their adoption.

• The five core standards — ISO 11615 (medicinal product information), ISO 11616 (pharmaceutical product information), ISO 11238 (substances — the SMS), ISO 11239 (dose forms, units of presentation, routes of administration), and ISO 11240 (units of measurement, leaning on UCUM).
• Why a suite — a 'medicine' is many entangled facts: the marketed product, the abstract pharmaceutical product, the active substances, the strength, the dose form, the units. IDMP gives each facet its own standard and identifier, then ties them together.
• The regulator's registries — the EMA implements IDMP through SPOR: master data for Substances, Products, Organisations and Referentials. These are the authoritative lookups everyone aligns to.
• How it's carried — IDMP concepts are increasingly exchanged via HL7 FHIR medicinal-product resources (and historically SPL), so IDMP is the model and FHIR is often the transport.

Use Case Example: An adverse-event report in Spain references a medicine by its IDMP identifiers — the same product, substance and strength identifiers a regulator in Germany resolves against SPOR. Because both sides speak IDMP, the safety signal aggregates across borders instead of being lost in national naming differences.

IDMP is a passport-and-visa system for medicines. A traveller isn't identified by name alone — you need passport number, nationality, date of birth, photo, each issued and verified by an authority, all cross-referenced. A medicine likewise can't be safely identified by brand name: IDMP pins down the product, the substances, the strength, the dose form and the units — each with its own authoritative identifier — so a recall or adverse event is unambiguous in every country.

The IDMP suite and the regulator's master data

Five ISO standards describe a medicine's facets; the EMA's SPOR registries are the authoritative lookups.

Health and life-science licensing field guide

Healthcare standards are where vocabulary rights matter most because real terms can be clinically and commercially sensitive.

The mental model: SNOMED says what the clinician meant, ICD says how it is classified for reporting/billing, LOINC says which observation was measured, FHIR carries the data, IDMP identifies the medicine, and GO/OBO explains biological function with evidence.