With IDMP (Identification of Medicinal Products) compliance deadlines approaching rapidly, IDMP Headstart is designed to let you begin working today in the IDMP structured data format, using your own product data. This turnkey solution includes Phlexglobal’s PhlexIDMP software, one of the only solutions fully aligned today with the current EU Implementation Guides (v2.x).
The result? By working with you own product information in PhlexIDMP, you can pinpoint where the required data resides, identify any gaps, and accurately scope the work required – accelerating IDMP-readiness and avoiding potential registration issues.
Efficiently and affordably start your IDMP preparations using your own data!
The two-year countdown to IDMP compliance began with the release of the EU IDMP Implementation Guide v2.0 in February 2021. For all products authorized via the EU's Centralized Procedure, you will need to validate and enrich the xEVMPD data in the SPOR PMS database to ensure it is IDMP-ready for any submissions. Plus, it's expected that by 2023 all new Centralized Procedure submissions must be in the IDMP structured data format and submitted by FHIR message in the eCTD.