ISO 11615

ISO 11615 establishes definitions and concepts required for the detailed description and unique identification of medicinal products. The scope of ISO 11615 ISO 11615 describes data elements and regulated medicinal product information during their entire life cycle...

ISO 11616

ISO 11616 International Standard “Health informatics — Identification of Medicinal Products — Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information”. ISO 11616 is intended to...

MDM

Master Data Management (MDM) is critical for IDMP compliance In matching IDMP´s required data with customer´s data there will be several systems identified which hold IDMP relevant data. In case of Marketing Authorisation Holders (MAHs) this will be...