EMA IDMP implementation guide V2


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 the basis for practical preparation activities such as performing Proof of Concept on the end-to-end process (generation and submission of FHIR messages, validation, interaction with eCTD) and test use cases (SmPC vs M3 data, placebo, use of IDs, ePI, DADI)

  • Abbreviation(s): EMA IG V2