SIST EN ISO 11615:2018 (identical to ISO 11615:2017 / EN ISO 11615:2017) is a health‑informatics standard that defines the data elements and structures required for the unique identification and exchange of regulated Medicinal Product information. It covers definitions, information modelling principles, primary identifiers and the detailed information needed to characterise medicinal products for human use across their entire life cycle - from development and authorisation through post‑marketing, renewal or withdrawal.
Keywords: ISO 11615, IDMP, medicinal product identification, health informatics, unique identification, regulated medicinal product.
Key topics and technical requirements
- Concepts and definitions required for uniquely identifying authorised and investigational medicinal products, including relationships with PhPID(s) and marketing authorisation numbers.
- Primary identifiers and code segments such as the Medicinal Product Identifier (MPID), Packaged Medicinal Product Identifier (PCID) and Medicinal Product Batch Identifiers (BAID1 / BAID2).
- Information modelling principles: conceptual, high‑level and detailed diagrams describing classes, attributes, relationships, translation and language support.
- Detailed information elements for an authorised medicinal product: product name, manufacturer/establishment (organisation), marketing authorisation, packaged medicinal product (package description), pharmaceutical product, ingredient/substance/strength, clinical particulars.
- Message exchange format and conformance terminology to support interoperable electronic exchange; the standard references the wider IDMP messaging standards for practical exchange scenarios.
- Coverage of both authorised and investigational medicinal product identifiers and related metadata.
Practical applications
- Enable consistent, machine‑readable unique identification of regulated medicinal products across regulatory submissions, pharmacovigilance, supply‑chain tracking and e‑health systems.
- Support structured data exchanges between regulatory authorities, marketing‑authorisation holders (MAHs), healthcare providers and health‑IT vendors.
- Improve interoperability for electronic submissions, batch tracing, adverse‑event reporting and electronic labeling by providing standardised data elements and structures.
- Foundation for implementing IDMP‑compliant databases, registries and messaging systems.
Who should use this standard
- National and regional regulators and medicines agencies
- Pharmaceutical companies (regulatory affairs, product data management)
- Health‑IT vendors, clinical systems and interoperability architects
- Standards implementers, data modelers and IT teams building IDMP‑compliant solutions
Related standards
- Part of the IDMP family of standards and IDMP messaging technical specifications (referenced by ISO 11615 for exchange purposes).
- EN ISO 11615:2017 is the European adoption; SIST EN ISO 11615:2018 is the Slovenian national adoption.
Using ISO 11615 helps organisations achieve consistent, lifecycle‑wide identification and exchange of regulated medicinal product information, supporting safer, more reliable regulatory and clinical workflows.
