European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Table of Contents

0 Table of Contents

1 Home

2 Artifacts Summary

2.1 01 EU EPI Bundle

2.2 02 EU EPI Composition (General)

2.3 03 EU EPI Composition (SmPC documents)

2.4 04 EU EPI Composition (Annex II documents)

2.5 05 EU EPI Composition (Labelling documents)

2.6 06 EU EPI Composition (PL documents)

2.7 07 EU EPI Composition (CAP authorised medicines)

2.8 08 EU EPI Composition (NAP authorised medicines)

2.9 09 EU EPI Composition (CAP SmPC documents)

2.10 10 EU EPI Composition (CAP Annex II documents)

2.11 11 EU EPI Composition (CAP Labelling documents)

2.12 12 EU EPI Composition (CAP PL documents)

2.13 13 EU EPI Composition (NAP SmPC documents)

2.14 14 EU EPI Composition (NAP Labelling documents)

2.15 15 EU EPI Composition (NAP PL documents)

2.16 16 EU EPI List

2.17 Authorization type extension used in List resource.

2.18 Image reference extension used in Composition resource.

2.19 Marketing authorisation holder extension used in List resource.

2.20 Medicine domain extension used in List resource.

2.21 Regulatory agency extension used in List resource.

2.22 Version number extension used in List resource.

2.23 01 Document Type Value Set

2.24 02 SmPC Code Value Set

2.25 03 Annex II Code Value Set

2.26 04 Labelling Code Value Set

2.27 05 PL Code Value Set

2.28 06 CAP Code Value Set

2.29 07 NAP-MRP-DCP Code Value Set

2.30 01 Document Type Code System

2.31 02 Section Code System

2.32 ePI Bundle example 1

2.33 ePI Composition example 1

2.34 ePI List example 1

2.35 Image SMPC example 1

2.36 Image SMPC example 2