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.

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.

This profile represents the constraints applied to SmPC documents.

This profile represents the constraints applied to Annex II documents.

This profile represents the constraints applied to Labelling documents.

This profile represents the constraints applied to Package Leaflet (PL) documents.

This profile represents the constraints applied to Centrally Authorised Products (CAP) Composition resources.

This profile represents the constraints applied to Nationally Authorised Products (NAP) Composition resources.

Profile for QRD validations of CAP SmPC EPI documents

Profile for QRD validations of CAP Annex II EPI documents

Profile for QRD validations of CAP Labelling EPI documents.

Profile for QRD validations of CAP Package Leaflet EPI documents.

Profile for QRD validations of NAP SmPC EPI documents.

Profile for QRD validations of NAP Labelling EPI documents.

Profile for QRD validations of NAP Package Leaflet EPI documents

This profile represents the constraints applied to the List resource used in ePI, as defined by the EU ePI Common Standard.

Authorization type extension used in List resource.

EMA number extension used in List resource.

EU number extension used in List resource.

GTIN extension used in Composition resource.

Marketing authorisation holder extension used in List resource.

Marketing authorisation holder display extension used in List resource.

Medicine domain extension used in List resource.

PMS ID extension used in Composition resource.

The EMA Quality Review of Documents (QRD) template version used for product information.

Regulatory agency extension used in List resource.

Regulatory agency display extension used in List resource.

Version number extension used in List resource.

ePI procedure number extension used in List resource.

List of section codes allowed in Annex II documents, defined in EMA's Referentials Management Service.

List of section codes allowed in Centrally Authorised Product (CAP) medicine documents, defined in EMA's Referentials Management Service.

EU EPI document type value set, defined in EMA's Referentials Management Service.

List of section codes allowed in Labelling documents, defined in EMA's Referentials Management Service.

EU EPI medicine domain value set, defined in EMA's Referentials Management Service.

List of section codes allowed in Nationally Authorised Product (NAP) medicine documents, defined in EMA's Referentials Management Service.

List of section codes allowed in Package Leaflet documents, defined in EMA's Referentials Management Service.

List of section codes allowed in SmPC documents, defined in EMA's Referentials Management Service.

EU EPI document type code system, defined in EMA's Referentials Management Service.

Medicine domains allowed in EU EPIs, defined in EMA's Referentials Management Service.

Section codes allowed in EU EPI document compositions, defined in EMA's Referentials Management Service.