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:

 

About version one

EU IG v1 is process agnostic 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. 

Although the business rules, data fields and specification presented in EU IG v1 are expected to be stable, they may be subject to modification as part of publication of EU IG v2.

The specification of the SPOR API, as reflected in ‘Chapter 6 – Technical specs on structure and Format’ is subject to development and testing. As with any software it may evolve over time and will be subject to change control.

Both this guide and the API can be expected to evolve with understanding of business processes and requirements and application of technological improvements, although no significant changes are expected.

EU IG v1 promotes awareness and transparency of the work of the SPOR (ISO IDMP) Task Force. Stakeholders can use the available information to anticipate impacts and future workload. However, EMA encourages stakeholders to be cautious when using the information in this document to define any software development or major investment, and to ensure that modifications may be implemented in their systems in the future.