IDMP-ISO-11615

IDMP authorised medicinal product data model.

Definition

ISO 11615:2017 describes the Medicinal Product concept, its MPID (Medicinal Product Identifier), authorisation status, presentation, packaging, manufacturer. Aligned with EMA SPOR (Substance, Product, Organisation, Referential) and FDA SPL (Structured Product Labeling). Progressive EU rollout since 2023.

Origin

ISO 11615 published 2017 by ISO/TC 215 (Health Informatics).

Example in context

Pfizer transmits to EMA the Comirnaty MPID with ISO 11615 data ; each presentation (5-dose vial, multi-dose) has its own PCID.

Related terms

• ISO 11616 — pharmaceutical product.