iso idmp

EU ISO IDMP Implementation Guideline – V1

Finally, EMA have released version 1 of the EU IDMP Implementation Guideline (EU IG v1).

Finally, EMA have released version 1 of the EU IDMP Implementation Guideline (EU IG v1).
February 13, 2020

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

Search News & Events

  • Filter by category


Related news and events

Christmas season greatings

Season’s Greetings

We wish you Happy ‘Xmas, Prosperous New Year and Health for you and your loved ones.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting