European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - final

Table of Contents

.. 0 Table of Contents
... 1 Home
... 2 Examples
... 3 Releases
... 4 Artifacts Summary
.... 4.1 01 EU EPI Bundle
.... 4.2 02 EU EPI Composition (General)
.... 4.3 03 EU EPI Composition (SmPC documents)
.... 4.4 04 EU EPI Composition (Annex II documents)
.... 4.5 05 EU EPI Composition (Labelling documents)
.... 4.6 06 EU EPI Composition (PL documents)
.... 4.7 07 EU EPI Composition (CAP authorised medicines)
.... 4.8 08 EU EPI Composition (NAP authorised medicines)
.... 4.9 09 EU EPI Composition (CAP SmPC documents)
.... 4.10 10 EU EPI Composition (CAP Annex II documents)
.... 4.11 11 EU EPI Composition (CAP Labelling documents)
.... 4.12 12 EU EPI Composition (CAP PL documents)
.... 4.13 13 EU EPI Composition (NAP SmPC documents)
.... 4.14 14 EU EPI Composition (NAP Labelling documents)
.... 4.15 15 EU EPI Composition (NAP PL documents)
.... 4.16 16 EU EPI List
.... 4.17 Authorization type
.... 4.18 EMA number
.... 4.19 ePI procedure number
.... 4.20 EU number
.... 4.21 GTIN
.... 4.22 Marketing authorisation holder
.... 4.23 Marketing authorisation holder display
.... 4.24 Medicine domain
.... 4.25 PMS ID
.... 4.26 QRD template version
.... 4.27 Regulatory agency
.... 4.28 Regulatory agency display
.... 4.29 Version number
.... 4.30 Annex II Codes
.... 4.31 CAP Codes
.... 4.32 Document Type
.... 4.33 Labelling Codes
.... 4.34 Medicine Domain
.... 4.35 NAP-MRP-DCP Codes
.... 4.36 Package Leaflet Codes
.... 4.37 SmPC Codes
.... 4.38 Document Type
.... 4.39 Medicine Domain
.... 4.40 Sections