Finally, EMA has released version 1 of the EU ISO IDMP Implementation Guideline (EU IG v1).
The EU IG v1 contains the following chapters:
- Introduction: Introduction, legal basis and scope of the EU IG for implementation of ISO IDMP
- Chapter 1 – Pre-registration requirements: Guidance on how to get access to SPOR and what to do prior to submission
- Chapter 2 – Initial submission: Guidance on which medicinal product information (data fields and business rules) shall be submitted
- Chapter 6 – Technical specifications on structure and format: Technical specifications for the API, contains description of principles, security, resources, calls, end-points
- Chapter 7 – Migration guide: migration rules between xEVMPD and PMS including backwards compatibility rules.
Stay tuned to Asphalion’s news for more information.