ISO 11615 Medicinal Product Identification (MPID) establishes definitions and concepts and describes data elements and their structural relationships, which are required for the unique identification and the detailed description of medicinal products.
FDA will continue to use the National Drug Code (NDC) as the unique identifier for medicinal products. NDC is composed of a labeler code, product code, and package code. By prefixing the NDC code with the ISO 3166-1 alpha-2 two digits county code “US”, it is compatible with ISO 11615 specification for medicinal product package identifier (PCID). The combination of country code “US” and the first two segments of the NDC conforms to the specification of medicinal product identifier (MPID).
FDA will continue using Structured Product Labeling (SPL), as described in ISO TS20443, for the exchange of labeling and listing submissions. FDA is collaborating with European Medicines Agency (EMA) and Health Level 7 (HL7) to incorporate the ISO IDMP standards into the Fast Healthcare Interoperability Resources (FHIR) specification.
The components and concepts that identify and characterize a medicinal product are described below:
- Medical Product Name – Name as authorized by the regulatory agency in the region
- Clinical Particulars – Indications and contraindications
- Pharmaceutical Product – Substance, dosage form, route of administration
- Packaged Medicinal Product – Description of all packaging, containers, manufactured product and its ingredients
- Marketing Authorization – Regional authorization number, application information, licensing number
- Manufacturer/Establishment – Manufacturer contact details and operations performed
- Versioning - Regulated documents by region