What is IDMP?
Identification of Medicinal Products (IDMP) is a set of five standards developed by the ISO to facilitate unique identification of medicinal products. The five ISO standards describe how to structure data on medicinal products according to defined information models. The collective goal for the standards (11238, 11239, 11240, 11615, and 11616) is to provide a common language for the identification of medicinal products.
ISO IDMP is a global initiative: the EMA has prepared an implementation guide describing the business rules to be applied in the EU, the FDA has published a guidance for industry and Swissmedic is assessing targets and priorities for the implementation of IDMP standards – making IDMP a worldwide standard.
in the European Union are being required to submit pack sizes information to xEVMPD for Critical Medicines by January 31, 2025 with the purpose to support the implementation of the European Shortages Monitoring Platform. Also, MAHs need to prepare structured data for manufacturers and pack sizes for the first enrichment process to PMS from Q1 2025.
Beyond compliance, well-managed data achieved through IDMP allows organizations to enhance their regulatory capabilities, achieve regulatory excellence, and create value for stakeholders across the product lifecycle. Furthermore, IDMP can serve as a precursor or booster for data management initiatives across the organization, making the RA the enabler of enterprise data management.
