--- title: EU IDMP Implementation Guide Version 1 Released | EXTEDO description: The EMA has published version 1 of the EU IDMP Implementation Guide with specification, data elements, and business rules for the implementation of ISO IDMP --- ![](https://www.extedo.com/hs-fs/hubfs/Pictures/Blog%20Post%20Banners/EU%20IDMP%20Implementation%20Guide%20Version%201%20Released.jpg?width=576&height=265&name=EU%20IDMP%20Implementation%20Guide%20Version%201%20Released.jpg) ![](https://www.extedo.com/hs-fs/hubfs/b0cb190cbd7efaee1435dde1e0fdaa3c.png) # EU IDMP Implementation Guide Version 1 Released The European Medicines Agency ([EMA](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_e)) has recently published Version 1 of the EU IDMP Implementation Guide, which aims to inform stakeholders about the specification, data elements, and associated business rules to help prepare for the implementation of ISO IDMP standards. We’ve written quite a few times about the new ISO [IDMP](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_i) standards that are set to be released soon. These standards will change how life science organizations manage drug information and safety throughout the EU. The European Medicines Agency (EMA) has recently published Version 1 of the EU IDMP Implementation Guide, which aims to inform stakeholders about the specification, data elements, and associated business rules to help prepare for the implementation of ISO IDMP standards. It reflects current understanding based on ongoing discussions at the [SPOR (ISO IDMP) Task Force](https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/spor-iso-idmp-task-force). The guide focuses on the processes for agnostics and does not contain information on the process for submission, exchange, or validation of medicinal product information. EU IG v2 will contain the operating model for PMS. While the rules, data, and specifications are expected to be stable, they are still officially a version 1.0 release and may be subject to some modifications over the coming months, as all parts of the documentation are subject to development and testing (e.g., Medical Devices, Reference Strengths). The key for the first version is to promote awareness and transparency of the work of the SPOR Task Force. You can read the [full guide here](https://www.ema.europa.eu/en/human-regulatory/research-development/data-medicines-iso-idmp-standards/spor-master-data/substances-products-data-management-services#eu-idmp-implementation-guide-section), but here are a few things you can learn: - The scope, legal basis, and implementation of ISO [IDMP](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_i). - Guidance on which data fields and business rules must be submitted. - Technical specifications on structure and format, including a description of principles, security, resources, calls, and endpoints for the [API](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_a). - Guidance on migration between [xEVMPD](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_p) and [PMS](https://www.extedo.com/glossary-of-regulatory-abbreviations#section_p), including backward compatibility rules. EMA is currently developing version two ('EU IG v2'), which will provide more information, including the basis for medicinal product data exchange in the EU. Version two is expected to cover maintenance, data quality assurance, data access and export rules, and some examples that companies can use for understanding the process. [EXTEDOpulse solutions](https://www.extedo.com/software/overview/extedopulse) are the perfect answer to constantly changing regulations and submission formats. ![whiteWaveTop](https://www.extedo.com/hs-fs/hubfs/whiteWaveTop.webp?width=576&height=44&name=whiteWaveTop.webp) ## Latest Blog Posts ![500](https://www.extedo.com/hs-fs/hubfs/Illustrations/Blog%20Posts/Blog%20Post%20Thumbnails/Introduction%20of%20ePI.png?width=64&height=64&name=Introduction%20of%20ePI.png) ![500](https://www.extedo.com/hs-fs/hubfs/Illustrations/Blog%20Posts/Blog%20Post%20Thumbnails/Introduction%20of%20ePI.png?width=500&height=500&name=Introduction%20of%20ePI.png) Introduction of ePI – The Future of Medicines Information [Read more **](https://www.extedo.com/blog/introduction-of-epi-the-future-of-medicines-information) ![500](https://www.extedo.com/hs-fs/hubfs/Illustrations/Blog%20Posts/Blog%20Post%20Thumbnails/EEXTEDO%20as%20Founding%20Member%20of%20Gravitate%20Healths%20Open%20E2E%20ePI%20Community.png?width=64&height=64&name=EEXTEDO%20as%20Founding%20Member%20of%20Gravitate%20Healths%20Open%20E2E%20ePI%20Community.png) ![500](https://www.extedo.com/hs-fs/hubfs/Illustrations/Blog%20Posts/Blog%20Post%20Thumbnails/EEXTEDO%20as%20Founding%20Member%20of%20Gravitate%20Healths%20Open%20E2E%20ePI%20Community.png?width=500&height=500&name=EEXTEDO%20as%20Founding%20Member%20of%20Gravitate%20Healths%20Open%20E2E%20ePI%20Community.png) Egyptian Drug Authority and EXTEDO Launch Phase II of Egypt’s Pharmaceutical Digital Transformation [Read more **](https://www.extedo.com/blog/egyptian-drug-authority-and-extedo-launch-phase-ii-of-egypts-pharmaceutical-digital-transformation) ![500](https://www.extedo.com/hs-fs/hubfs/Pictures/Blog%20Post%20Thumbnails/Upcoming%20Events%20at%20the%20European%20Medicines%20Agency%20(EMA)%20Your%20Essential%20Guide%20for%20Planning%20(thumb).png?width=64&height=64&name=Upcoming%20Events%20at%20the%20European%20Medicines%20Agency%20(EMA)%20Your%20Essential%20Guide%20for%20Planning%20(thumb).png) ![500](https://www.extedo.com/hs-fs/hubfs/Pictures/Blog%20Post%20Thumbnails/Upcoming%20Events%20at%20the%20European%20Medicines%20Agency%20(EMA)%20Your%20Essential%20Guide%20for%20Planning%20(thumb).png?width=500&height=500&name=Upcoming%20Events%20at%20the%20European%20Medicines%20Agency%20(EMA)%20Your%20Essential%20Guide%20for%20Planning%20(thumb).png) EMA PMS Info Day 2026: The Future of Data-Driven Medicines Regulation in Europe [Read more **](https://www.extedo.com/blog/ema-pms-info-day-2026-the-future-of-data-driven-medicines-regulation-in-europe) ![500](https://www.extedo.com/hs-fs/hubfs/Illustrations/Blog%20Posts/Blog%20Post%20Thumbnails/US%20FDA_eCTD%20v4.png?width=64&height=64&name=US%20FDA_eCTD%20v4.png) ![500](https://www.extedo.com/hs-fs/hubfs/Illustrations/Blog%20Posts/Blog%20Post%20Thumbnails/US%20FDA_eCTD%20v4.png?width=500&height=500&name=US%20FDA_eCTD%20v4.png) US FDA CDER Reveals Why Most eCTD v4 Submissions Fail (And How to Fix Them) [Read more **](https://www.extedo.com/blog/us-fda-cder-reveals-why-most-ectd-v4-submissions-fail-and-how-to-fix-them) [See more blog posts](https://www.extedo.com/blog) ```json { "@context" : "https://schema.org", "@type" : "BlogPosting", "author" : { "@type" : "Person", "name" : "EXTEDO", "url" : "https://www.extedo.com/blog/author/extedo" }, "dateModified" : "2025-08-08T13:12:58.749Z", "datePublished" : "2020-03-24T12:30:00.000Z", "headline" : "EU IDMP Implementation Guide Version 1 Released", "mainEntityOfPage" : { "@id" : "https://www.extedo.com/blog/eu-idmp-implementation-guide-version-1-released", "@type" : "WebPage" }, "publisher" : { "@type" : "Organization", "logo" : { "@type" : "ImageObject", "url" : "https://www.extedo.com/hubfs/logo.png" }, "name" : "EXTEDO GmbH" } } ```