German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide
0.7.0 - ci-build
German (DEU) electronic Product Information Leaflet (ePIL) Implementation Guide - Local Development build (v0.7.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
| Draft as of 2026-05-04 |
Definitions for the DEU-ePIL-Section-Change extension.
Guidance on how to interpret the contents of this table can be foundhere
| 0. Extension | |
| Definition | Extension to mark sections (chapters) that have been changed in this version of the document. Used in conjunction with Composition.relatesTo to reference previous versions and indicate which specific sections have modifications. Applicable to sections at any nesting level (Level 1, Level 2, or Level 3). Optional Extension Element - found in all resources. |
| Short | DEU ePI Section Change ExtensionOptional Extensions Element |
| Control | 0..* |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| 2. Extension.extension | |
| Definition | An Extension May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. |
| Short | ExtensionAdditional content defined by implementations |
| Comments | There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone. |
| Control | 0..0* |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Alternate Names | extensions, user content |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 4. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Section-Change |
| 6. Extension.value[x] | |
| Definition | When true, indicates that this section has been modified compared to the previous version referenced in Composition.relatesTo. When false or absent, the section is unchanged. Value of extension - must be one of a constrained set of the data types (see Extensibility for a list). |
| Short | Indicates whether this section has changedValue of extension |
| Control | 10..1 This element is affected by the following invariants: ext-1 |
| Type | boolean, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, Expression, CodeableReference, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |
Guidance on how to interpret the contents of this table can be foundhere
| 0. Extension | |
| Definition | Extension to mark sections (chapters) that have been changed in this version of the document. Used in conjunction with Composition.relatesTo to reference previous versions and indicate which specific sections have modifications. Applicable to sections at any nesting level (Level 1, Level 2, or Level 3). |
| Short | DEU ePI Section Change Extension |
| 2. Extension.extension | |
| Control | 0..0 |
| 4. Extension.url | |
| Fixed Value | http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Section-Change |
| 6. Extension.value[x] | |
| Definition | When true, indicates that this section has been modified compared to the previous version referenced in Composition.relatesTo. When false or absent, the section is unchanged. |
| Short | Indicates whether this section has changed |
| Control | 1..? |
| Type | boolean, date, Meta, Address, Attachment, integer, Count, DataRequirement, Dosage, uuid, Identifier, RatioRange, Coding, SampledData, id, positiveInt, Distance, Availability, integer64, Period, Duration, canonical, Range, RelatedArtifact, base64Binary, UsageContext, Timing, decimal, ExtendedContactDetail, CodeableConcept, ParameterDefinition, dateTime, code, string, oid, instant, ContactPoint, HumanName, Money, markdown, Ratio, Age, Reference, TriggerDefinition, Quantity, uri, url, Annotation, ContactDetail, Expression, CodeableReference, Signature, unsignedInt, time |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
Guidance on how to interpret the contents of this table can be foundhere
| 0. Extension | |
| Definition | Extension to mark sections (chapters) that have been changed in this version of the document. Used in conjunction with Composition.relatesTo to reference previous versions and indicate which specific sections have modifications. Applicable to sections at any nesting level (Level 1, Level 2, or Level 3). |
| Short | DEU ePI Section Change Extension |
| Control | 0..* |
| Is Modifier | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| 2. Extension.id | |
| Definition | Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces. |
| Short | Unique id for inter-element referencing |
| Control | 0..1 This element is affected by the following invariants: ele-1 |
| Type | id |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| 4. Extension.extension | |
| Definition | An Extension |
| Short | Extension |
| Control | 0..0 |
| Type | Extension |
| Is Modifier | false |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))ext-1: Must have either extensions or value[x], not both ( extension.exists() != value.exists()) |
| Slicing | This element introduces a set of slices on Extension.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators: |
| 6. Extension.url | |
| Definition | Source of the definition for the extension code - a logical name or a URL. |
| Short | identifies the meaning of the extension |
| Comments | The definition may point directly to a computable or human-readable definition of the extensibility codes, or it may be a logical URI as declared in some other specification. The definition SHALL be a URI for the Structure Definition defining the extension. |
| Control | 1..1 |
| Type | uri |
| Is Modifier | false |
| XML Format | In the XML format, this property is represented as an attribute. |
| Summary | false |
| Fixed Value | http://fhir.pharmaprotect.de/digital/epil-fhir-ig/StructureDefinition/DEU-ePIL-Section-Change |
| 8. Extension.value[x] | |
| Definition | When true, indicates that this section has been modified compared to the previous version referenced in Composition.relatesTo. When false or absent, the section is unchanged. |
| Short | Indicates whether this section has changed |
| Control | 1..1 This element is affected by the following invariants: ext-1 |
| Type | boolean |
| [x] Note | SeeChoice of Data Typesfor further information about how to use [x] |
| Is Modifier | false |
| Primitive Value | This primitive element may be present, or absent, or replaced by an extension |
| Summary | false |
| Invariants | ele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count())) |