European Medicines Regulatory Network (EMRN) Electronic Product Information (ePI) Implementation Guide
1.0.0 - ci-build
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
Contents:
This page provides a list of the FHIR artifacts defined as part of this implementation guide.
These define constraints on FHIR resources for systems conforming to this implementation guide.
| 01 EU EPI Bundle |
This profile represents the constraints applied to the Bundle resource used in ePI, as defined by the EU ePI Common Standard. ePI is composed of multiple documents (summary of product characteristics, package leaflet, etc.). Each document is represented by a Bundle with type=document. |
| 02 EU EPI Composition (General) |
This profile represents the constraints applied to the Composition resource used in ePI, as defined by the EU ePI Common Standard. The Composition captures the section headings, sub-section headings, and narrative text (For example, paragraphs, bulleted lists, tables) in an ePI document. |
| 03 EU EPI Composition (SmPC documents) |
This profile represents the constraints applied to SmPC documents. |
| 04 EU EPI Composition (Annex II documents) |
This profile represents the constraints applied to Annex II documents. |
| 05 EU EPI Composition (Labelling documents) |
This profile represents the constraints applied to Labelling documents. |
| 06 EU EPI Composition (PL documents) |
This profile represents the constraints applied to Package Leaflet (PL) documents. |
| 07 EU EPI Composition (CAP authorised medicines) |
This profile represents the constraints applied to Centrally Authorised Products (CAP) Composition resources. |
| 08 EU EPI Composition (NAP authorised medicines) |
This profile represents the constraints applied to Nationally Authorised Products (NAP) Composition resources. |
| 09 EU EPI Composition (CAP SmPC documents) |
Profile for QRD validations of CAP SmPC EPI documents |
| 10 EU EPI Composition (CAP Annex II documents) |
Profile for QRD validations of CAP Annex II EPI documents |
| 11 EU EPI Composition (CAP Labelling documents) |
Profile for QRD validations of CAP Labelling EPI documents. |
| 12 EU EPI Composition (CAP PL documents) |
Profile for QRD validations of CAP Package Leaflet EPI documents. |
| 13 EU EPI Composition (NAP SmPC documents) |
Profile for QRD validations of NAP SmPC EPI documents. |
| 14 EU EPI Composition (NAP Labelling documents) |
Profile for QRD validations of NAP Labelling EPI documents. |
| 15 EU EPI Composition (NAP PL documents) |
Profile for QRD validations of NAP Package Leaflet EPI documents |
| 16 EU EPI List |
This profile represents the constraints applied to the List resource used in ePI, as defined by the EU ePI Common Standard. |
These define constraints on FHIR data types for systems conforming to this implementation guide.
| Authorization type extension used in List resource. |
Authorization type extension used in List resource. |
| Image reference extension used in Composition resource. |
Image reference extension used in Composition resource. |
| Marketing authorisation holder display extension used in List resource. |
Marketing authorisation holder display extension used in List resource. |
| Marketing authorisation holder extension used in List resource. |
Marketing authorisation holder extension used in List resource. |
| Medicine domain extension used in List resource. |
Medicine domain extension used in List resource. |
| Regulatory agency display extension used in List resource. |
Regulatory agency display extension used in List resource. |
| Regulatory agency extension used in List resource. |
Regulatory agency extension used in List resource. |
| Version number extension used in List resource. |
Version number extension used in List resource. |
| ePI procedure number extension used in List resource. |
ePI procedure number extension used in List resource. |
These define sets of codes used by systems conforming to this implementation guide.
| 01 Document Type Value Set |
EU EPI document type value set, defined in EMA's Referentials Management Service. |
| 02 SmPC Code Value Set |
List of section codes allowed in SmPC documents, defined in EMA's Referentials Management Service. |
| 03 Annex II Code Value Set |
List of section codes allowed in Annex II documents, defined in EMA's Referentials Management Service. |
| 04 Labelling Code Value Set |
List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service. |
| 05 PL Code Value Set |
List of section codes allowed in Package Leaflet documents, defined in EMA's Referentials Management Service. |
| 06 CAP Code Value Set |
List of section codes allowed in Centrally Authorised Product (CAP) medicine documents, defined in EMA's Referentials Management Service. |
| 07 NAP-MRP-DCP Code Value Set |
List of section codes allowed in Nationally Authorised Product (NAP) medicine documents, defined in EMA's Referentials Management Service. |
| 08 Medicine Domain Value Set |
EU EPI medicine domain value set, defined in EMA's Referentials Management Service. |
These define new code systems used by systems conforming to this implementation guide.
| 01 Document Type Code System |
EU EPI document type code system, defined in EMA's Referentials Management Service. |
| 02 Section Code System |
Section codes allowed in EU EPI document compositions, defined in EMA's Referentials Management Service. |
| 03 Medicine Domain Code System |
Medicine domains allowed in EU EPIs, defined in EMA's Referentials Management Service. |
These are example instances that show what data produced and consumed by systems conforming with this implementation guide might look like.
| Image SMPC example 1 |
Example of the use of the Binary resource to store document images |
| Image SMPC example 2 |
Example of the use of the Binary resource to store document images |
| ePI Bundle example 1 |
Example of the use of the resource |
| ePI Composition example 1 |
Example of the use of the resource |
| ePI List example 1 |
Example of the use of the resource |