EMA Revises IDMP Implementation Guidelines for ISO 11238

As the Brexit transformation and transitions are in full pace, the European Medicines Agency (EMA) is firm on releasing periodical updates for implementation of the Identification of Medicinal Products (IDMP). Stepping in that direction, the International Organization for Standardization (ISO) has recently updated the ISO/TS 19844, “Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances”.

In the latest revision, details for agencies and vendors working on the substance repositories on Substance Groups 1 to 3 have been specified as listed below.

  • Data elements necessary for defining Substances and Specified Substances Groups 1 to 3
  • The logical use of data elements as defined in ISO 11238
  • Substances and Specified Substances Groups 1 to 3 business rules for:
    • Determining necessary data element
    • Distinguishing and defining materials according to ISO 11238
    • Triggering the assignment of identifiers

To make the current revision (2018) clear and simple, some of the samples, detailed specifications and sample scenarios have also been included which were not published in the earlier versions 2015 and 2016. As more revisions are expected to follow the current update to further refine the understanding and implementation of IDMP, the onus lies on medicinal product manufacturers to be in comprehensive understanding of the IDMP guidelines. Be informed and compliant.

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