EMA published the current version, version 2.0 (EU IG v2.0), in February 2021. It mainly serves to support the European medicines regulatory network in preparing for Step 1. On top of the information in version 1, it provides:
high level principles of the target operating model for submitting and maintaining medicinal product data in the EU
further guidance on how to populate the PMS data elements
the basis for medicinal product data exchange in the EU
EMA plans to publish a third version (EU IG v3.0) to support the implementation of Step 2 and to reflect the latest agreements and details available.
EU IG v2.0 mainly supports the implementation of Step 1 and is required to prepare for data submission via the PMS on medicinal products authorised through the centralised procedure.
It provides:
clarification on the concepts of the target operating model of PMS;
clarification on the processes for submission, exchange or validation of medicinal product information;
detailed guidance on registration requirements as well as information on product data access;
clarification on the data elements for electronic submission of information on medicinal products for human use and the applicable business rules;
practical examples to support SPOR users in correctly structuring their product data in situations where the direct application of ISO IDMP may be complex.
The information provided in EU IG v2.0 enables the European medicines regulatory network to prepare for the submission of data on all medicinal products for human use authorised in the EU. It offers a basis for practical preparation activities, such as:
performing proofs-of-concept on end-to-end processes involving the generation and submission of FHIR messages, validation and interaction with eCTD;
testing the use cases.
The European medicines regulatory network has agreed a phased release plan for the EU Implementation Guide. EMA will release minor versions (EU IG v2.1 and EU IG v2.2) during 2021, to reflect the latest agreements and details available and enhance quality.
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