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Articles tagged with “plm-portal”

EMA ePI FHIR v1.0 Implementation Readiness Guide

A 2026 implementation guide to EMA ePI FHIR v1.0, covering the resource graph, PLM versus external generation, identifiers, procedure timing, validation, and rollout readiness.

22 min read

9/19/2026

ema epi fhir v1.0 electronic product information eu epi common standard plm portal regulatory submissions fhir validation product information centralised procedures regulatory operations