description: 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.
package_name: eu.epi.jan2025
derivation: constraint
name: EUEpiCompositionLabeling
type: Composition
elements:
  date: {short: Date of last revision for this version of the authorized EPI document., index: 12}
  section:
    short: Level 1 section heading for the whole EPI
    index: 15
    elements:
      title: {short: Section heading defined by the market authorization holder, index: 16}
      code:
        short: Section heading defined by the health authority. Cannot be changed by the market authorization holder
        index: 17
        elements:
          coding:
            elements:
              code:
                binding: {strength: required, valueSet: 'http://ema.europa.eu/fhir/vs/epilabellingqrdcodes'}
                index: 18
      text: {short: 'Narrative text for this section (e.g., paragraphs, bulleted lists, tables).', index: 19}
      emptyReason: {short: Reason the section is empty., index: 20}
      section:
        type: BackboneElement
        short: Nested sub-section headings for level 2
        index: 21
        elements:
          title: {short: Section heading defined by the market authorization holder, index: 22}
          code:
            short: Code defined by the health authority
            index: 23
            elements:
              coding:
                elements:
                  code:
                    binding: {strength: required, valueSet: 'http://ema.europa.eu/fhir/vs/epilabellingqrdcodes'}
                    index: 24
          text: {short: Narrative text for this section., index: 25}
          emptyReason: {short: Reason the section is empty., index: 26}
          section:
            type: BackboneElement
            short: Nested sub-section headings for level 3.
            index: 27
            elements:
              title: {index: 28}
              code:
                short: Code defined by the health authority
                index: 29
                elements:
                  coding:
                    elements:
                      code:
                        binding: {strength: required, valueSet: 'http://ema.europa.eu/fhir/vs/epilabellingqrdcodes'}
                        index: 30
              text: {short: Narrative text for this section., index: 31}
              emptyReason: {short: Reason the section is empty., index: 32}
              section:
                type: BackboneElement
                short: Nested sub-section headings for level 4.
                index: 33
                elements:
                  title: {index: 34}
                  code:
                    short: Code defined by the health authority
                    index: 35
                    elements:
                      coding:
                        elements:
                          code:
                            binding: {strength: required, valueSet: 'http://ema.europa.eu/fhir/vs/epilabellingqrdcodes'}
                            index: 36
                  text: {short: Narrative text for this section., index: 37}
                  emptyReason: {short: Reason the section is empty., index: 38}
                  section:
                    type: BackboneElement
                    short: Nested sub-section headings for level 5.
                    index: 39
                    elements:
                      title: {index: 40}
                      code:
                        short: Code defined by the health authority
                        index: 41
                        elements:
                          coding:
                            elements:
                              code:
                                binding: {strength: required, valueSet: 'http://ema.europa.eu/fhir/vs/epilabellingqrdcodes'}
                                index: 42
                      text: {short: Narrative text for this section., index: 43}
                      emptyReason: {short: Reason the section is empty., index: 44}
                    required: [title, code]
                required: [title, code]
            required: [title, code]
        required: [title, code]
    required: [section, title, code]
  type:
    short: Type of EPI document template
    index: 9
    elements:
      coding:
        elements:
          code:
            pattern: {type: Code, value: '100000155535'}
            index: 10
  title: {short: Title of the EPI document, index: 14}
  author: {short: The Organization responsible for the EPI, index: 13}
  extension:
    short: The use of the imageReference extension avoids warning and error messages in common FHIR validators.
    index: 3
    slicing:
      rules: open
      ordered: false
      discriminator:
      - {path: url, type: value}
      min: null
      slices:
        imageReference:
          match: {url: null}
          schema: {type: Extension, url: 'http://ema.europa.eu/fhir/StructureDefinition/ext-epi-image-reference', index: 4}
          min: 0
  contained: {short: Images in ePI Composition documents included as contained binary resources., index: 2}
  status: {short: Status of the composition document., index: 8}
  language: {short: The language of the EPI document narrative text, index: 0}
  identifier:
    short: Unique identifier only for this version of the Composition.
    index: 5
    elements:
      system: {index: 6}
      value: {index: 7}
    required: [value, system]
  subject: {short: 'In current implementation, a self reference to the bundle document or composition.', index: 11}
  text: {short: 'Text summary of the resource, for human interpretation.', index: 1}
package_version: 1.0.0
extensions:
  imageReference: {url: 'http://ema.europa.eu/fhir/StructureDefinition/ext-epi-image-reference', min: 0, type: Extension, index: 4}
class: profile
kind: resource
url: http://ema.europa.eu/fhir/StructureDefinition/EUEpiCompositionLabeling
base: http://hl7.org/fhir/StructureDefinition/Composition
version: null
required: [section, language]