Finally, EMA has released version 1 of the EU ISO IDMP Implementation Guideline (EU IG v1).
With this release, EMA is providing the information about the implementation requirements of the ISO IDMP standards and terminologies in the EU.
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.
Moreover, if you need anything related to ISO IDMP or RIMS implementation, do not hesitate to contact [email protected]
