IDMP — Substances, Products & Packaging

Five standards, one coherent identity system

IDMP isn't one document — it's a family of five ISO standards that interlock. Knowing which does what is the day-job literacy a regulatory-data role expects:

• ISO 11238 — Substances. Identifies the substance itself (the active or inactive material) with a Substance ID.
• ISO 11239 — Pharmaceutical dose forms, units of presentation, routes of administration. The controlled vocabularies for how a product is presented and given.
• ISO 11240 — Units of measurement. Standardised units (anchored to UCUM) so strengths and quantities compare across regions.
• ISO 11615 — Medicinal products. The authorised product as a regulator licenses it, identified by an MPID.
• ISO 11616 — Pharmaceutical products. The scientific product (substances + strength + dose form, independent of brand or packaging), identified by a PhPID.

Licensing note: the ISO IDMP texts are paywalled. Everything below is an illustrative model of the structure, with example identifiers — not reproduced standard content.

The identifier family — why so many?

Each identifier answers a different question, and conflating them is exactly the safety bug IDMP exists to prevent:

• MPID — this authorised product, in this market (brand, marketing-authorisation holder, country).
• PhPID — the science: same substances + strength + dose form, regardless of brand. Two brands of the same generic share a PhPID but have different MPIDs.
• PCID — this packaged configuration (the 28-tablet blister vs the 100-tablet bottle).
• Substance ID — the material a product contains.

The faceted model

A medicinal product hasPharmaceuticalProduct a scientific product, which containsSubstance one or more substances at a strength (a quantity in ISO 11240 units), and is packaged into configurations each with its own PCID. Reasoning over this graph is what lets a regulator answer 'every authorised product, in any country, that contains substance X above strength Y.'

Use Case Example: A safety signal implicates a specific active substance. With IDMP, an agency walks Substance ID → every PhPID that contains it → every MPID (brand/market) carrying that PhPID → every PCID on shelves — turning a vague 'recall things with drug X' into an exact, packaging-level worklist.

IDMP's identifiers are the ISBN, the edition, and the physical copy of a book. The work ('Hamlet') is the science — the PhPID. A specific published edition by a specific publisher in a specific country is the authorised product — the MPID. The boxed set vs single paperback is the packaging — the PCID. Libraries learned long ago that you need all three levels; pharmacovigilance needs them for the same reason — to recall exactly the right thing.

The faceted IDMP graph

Substance feeds the pharmaceutical (scientific) product, which a medicinal (authorised) product realises and packaging configures — each facet with its own identifier.