<status value="draft"/> <date value="2025-07-01T13:56:00+00:00"/> <publisher value="AGES"/> <contact> <name value="AGES"/> <telecom> <system value="url"/> <value value="https://www.ages.at/"/> </telecom> </contact> <description value="Defines the package information of a medicinal product"/> <jurisdiction> <coding> <system value="urn:iso:std:iso:3166"/> <code value="AT"/> <display value="Austria"/> </coding> </jurisdiction> <fhirVersion value="5.0.0"/> <mapping> <identity value="w5"/> <uri value="http://hl7.org/fhir/fivews"/> <name value="FiveWs Pattern Mapping"/> </mapping> <mapping> <identity value="idmp"/> <uri value="https://www.iso.org/obp/ui/#iso:std:iso:11615"/> <name value="IDMP Mapping"/> </mapping> <mapping> <identity value="rim"/> <uri value="http://hl7.org/v3"/> <name value="RIM Mapping"/> </mapping> <kind value="resource"/> <abstract value="false"/> <type value="PackagedProductDefinition"/> <baseDefinition value="http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition"/> <derivation value="constraint"/> <snapshot> <extension url="http://hl7.org/fhir/tools/StructureDefinition/snapshot-base-version"> <valueString value="5.0.0"/> </extension> <element id="PackagedProductDefinition"> <path value="PackagedProductDefinition"/> <short value="A medically related item or items, in a container or package"/> <definition value="A medically related item or items, in a container or package."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition"/> <min value="0"/> <max value="*"/> </base> <constraint> <key value="dom-2"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL NOT contain nested Resources"/> <expression value="contained.contained.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-3"/> <severity value="error"/> <human value="If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource"/> <expression value="contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-4"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated"/> <expression value="contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <key value="dom-5"/> <severity value="error"/> <human value="If a resource is contained in another resource, it SHALL NOT have a security label"/> <expression value="contained.meta.security.empty()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <constraint> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice"> <valueBoolean value="true"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bestpractice-explanation"> <valueMarkdown value="When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time."/> </extension> <key value="dom-6"/> <severity value="warning"/> <human value="A resource should have narrative for robust management"/> <expression value="text.`div`.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/DomainResource"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Entity, Role, or Act"/> </mapping> <mapping> <identity value="w5"/> <map value="administrative.medication"/> </mapping> <mapping> <identity value="idmp"/> <map value="Packaged Medicinal Product"/> </mapping> </element> <element id="PackagedProductDefinition.id"> <path value="PackagedProductDefinition.id"/> <short value="Logical id of this artifact"/> <definition value="The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes."/> <comment value="Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="PackagedProductDefinition.meta"> <path value="PackagedProductDefinition.meta"/> <short value="Metadata about the resource"/> <definition value="The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.meta"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Meta"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="PackagedProductDefinition.implicitRules"> <path value="PackagedProductDefinition.implicitRules"/> <short value="A set of rules under which this content was created"/> <definition value="A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc."/> <comment value="Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.implicitRules"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation"/> <isSummary value="true"/> </element> <element id="PackagedProductDefinition.language"> <path value="PackagedProductDefinition.language"/> <short value="Language of the resource content"/> <definition value="The base language in which the resource is written."/> <comment value="Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute)."/> <min value="0"/> <max value="1"/> <base> <path value="Resource.language"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Language"/> </extension> <strength value="required"/> <description value="IETF language tag for a human language"/> <valueSet value="http://hl7.org/fhir/ValueSet/all-languages|5.0.0"/> <additional> <purpose value="starter"/> <valueSet value="http://hl7.org/fhir/ValueSet/languages"/> </additional> </binding> </element> <element id="PackagedProductDefinition.text"> <path value="PackagedProductDefinition.text"/> <short value="Text summary of the resource, for human interpretation"/> <definition value="A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety."/> <comment value="Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later."/> <alias value="narrative"/> <alias value="html"/> <alias value="xhtml"/> <alias value="display"/> <min value="0"/> <max value="1"/> <base> <path value="DomainResource.text"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Narrative"/> </type> <condition value="dom-6"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="Act.text?"/> </mapping> </element> <element id="PackagedProductDefinition.contained"> <path value="PackagedProductDefinition.contained"/> <short value="Contained, inline Resources"/> <definition value="These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning."/> <comment value="This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels."/> <alias value="inline resources"/> <alias value="anonymous resources"/> <alias value="contained resources"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.contained"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Resource"/> </type> <condition value="dom-2"/> <condition value="dom-4"/> <condition value="dom-3"/> <condition value="dom-5"/> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="PackagedProductDefinition.extension"> <path value="PackagedProductDefinition.extension"/> <short value="Additional content defined by implementations"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource. 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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="PackagedProductDefinition.modifierExtension"> <path value="PackagedProductDefinition.modifierExtension"/> <short value="Extensions that cannot be ignored"/> <definition value="May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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 is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="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."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="DomainResource.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="PackagedProductDefinition.identifier"> <path value="PackagedProductDefinition.identifier"/> <slicing> <discriminator> <type value="value"/> <path value="system"/> </discriminator> <description value="The package has the ID PZN as well as a Pharos ID from the Austrian Agency"/> <ordered value="false"/> <rules value="open"/> </slicing> <short value="A unique identifier for this package as whole - not for the content of the package (pharmaceutical registration number (Pharmazentralnummer (PZN)))"/> <definition value="A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations."/> <min value="2"/> <max value="*"/> <base> <path value="PackagedProductDefinition.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> <profile value="https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> <mapping> <identity value="idmp"/> <map value="Packaged Medicinal Product.PCID"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN"> <path value="PackagedProductDefinition.identifier"/> <sliceName value="PZN"/> <short value="A unique identifier for this package as whole - not for the content of the package"/> <definition value="A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations."/> <min value="1"/> <max value="1"/> <base> <path value="PackagedProductDefinition.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> <mapping> <identity value="idmp"/> <map value="Packaged Medicinal Product.PCID"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN.id"> <path value="PackagedProductDefinition.identifier.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN.extension"> <path value="PackagedProductDefinition.identifier.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN.use"> <path value="PackagedProductDefinition.identifier.use"/> <short value="usual | official | temp | secondary | old (If known)"/> <definition value="The purpose of this identifier."/> <comment value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.use"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse"/> </extension> <strength value="required"/> <description value="Identifies the purpose for this identifier, if known ."/> <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"/> </binding> <mapping> <identity value="v2"/> <map value="N/A"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.code or implied by context"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN.type"> <path value="PackagedProductDefinition.identifier.type"/> <short value="Description of identifier"/> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/> <comment value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/> <requirements value="Allows users to make use of identifiers when the identifier system is not known."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType"/> </extension> <strength value="extensible"/> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/> <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/> </binding> <mapping> <identity value="v2"/> <map value="CX.5"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.code or implied by context"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN.system"> <path value="PackagedProductDefinition.identifier.system"/> <short value="The namespace for the identifier value"/> <definition value="Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique."/> <comment value="Identifier.system is always case sensitive."/> <requirements value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.system"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <patternUri value="https://argepharma.fcio.at"/> <example> <label value="General"/> <valueUri value="http://www.acme.com/identifiers/patient"/> </example> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.4 / EI-2-4"/> </mapping> <mapping> <identity value="rim"/> <map value="II.root or Role.id.root"/> </mapping> <mapping> <identity value="servd"/> <map value="./IdentifierType"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN.value"> <path value="PackagedProductDefinition.identifier.value"/> <short value="The value that is unique"/> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/> <comment value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.value"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <example> <label value="General"/> <valueString value="123456"/> </example> <condition value="ident-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.1 / EI.1"/> </mapping> <mapping> <identity value="rim"/> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/> </mapping> <mapping> <identity value="servd"/> <map value="./Value"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN.period"> <path value="PackagedProductDefinition.identifier.period"/> <short value="Time period when id is/was valid for use"/> <definition value="Time period during which identifier is/was valid for use."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.period"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.7 + CX.8"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.effectiveTime or implied by context"/> </mapping> <mapping> <identity value="servd"/> <map value="./StartDate and ./EndDate"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:PZN.assigner"> <path value="PackagedProductDefinition.identifier.assigner"/> <short value="Organization that issued id (may be just text)"/> <definition value="Organization that issued/manages the identifier."/> <comment value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.assigner"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.4 / (CX.4,CX.9,CX.10)"/> </mapping> <mapping> <identity value="rim"/> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/> </mapping> <mapping> <identity value="servd"/> <map value="./IdentifierIssuingAuthority"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber"> <path value="PackagedProductDefinition.identifier"/> <sliceName value="referenceNumber"/> <short value="A unique identifier for this package as whole - not for the content of the package"/> <definition value="A unique identifier for this package as whole - not the the content of the package. Unique instance identifiers assigned to a package by manufacturers, regulators, drug catalogue custodians or other organizations."/> <min value="1"/> <max value="1"/> <base> <path value="PackagedProductDefinition.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="w5"/> <map value="FiveWs.class"/> </mapping> <mapping> <identity value="idmp"/> <map value="Packaged Medicinal Product.PCID"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.id"> <path value="PackagedProductDefinition.identifier.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.extension"> <path value="PackagedProductDefinition.identifier.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.use"> <path value="PackagedProductDefinition.identifier.use"/> <short value="usual | official | temp | secondary | old (If known)"/> <definition value="The purpose of this identifier."/> <comment value="Applications can assume that an identifier is permanent unless it explicitly says that it is temporary."/> <requirements value="Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.use"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one."/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierUse"/> </extension> <strength value="required"/> <description value="Identifies the purpose for this identifier, if known ."/> <valueSet value="http://hl7.org/fhir/ValueSet/identifier-use|5.0.0"/> </binding> <mapping> <identity value="v2"/> <map value="N/A"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.code or implied by context"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.type"> <path value="PackagedProductDefinition.identifier.type"/> <short value="Description of identifier"/> <definition value="A coded type for the identifier that can be used to determine which identifier to use for a specific purpose."/> <comment value="This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type."/> <requirements value="Allows users to make use of identifiers when the identifier system is not known."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="IdentifierType"/> </extension> <strength value="extensible"/> <description value="A coded type for an identifier that can be used to determine which identifier to use for a specific purpose."/> <valueSet value="http://hl7.org/fhir/ValueSet/identifier-type"/> </binding> <mapping> <identity value="v2"/> <map value="CX.5"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.code or implied by context"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.system"> <path value="PackagedProductDefinition.identifier.system"/> <short value="The namespace for the identifier value"/> <definition value="Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique."/> <comment value="Identifier.system is always case sensitive."/> <requirements value="There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.system"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <patternUri value="https://www.ages.at/fhir/referenceNumber"/> <example> <label value="General"/> <valueUri value="http://www.acme.com/identifiers/patient"/> </example> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.4 / EI-2-4"/> </mapping> <mapping> <identity value="rim"/> <map value="II.root or Role.id.root"/> </mapping> <mapping> <identity value="servd"/> <map value="./IdentifierType"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.value"> <path value="PackagedProductDefinition.identifier.value"/> <short value="The value that is unique"/> <definition value="The portion of the identifier typically relevant to the user and which is unique within the context of the system."/> <comment value="If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.value"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <example> <label value="General"/> <valueString value="123456"/> </example> <condition value="ident-1"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.1 / EI.1"/> </mapping> <mapping> <identity value="rim"/> <map value="II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)"/> </mapping> <mapping> <identity value="servd"/> <map value="./Value"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.period"> <path value="PackagedProductDefinition.identifier.period"/> <short value="Time period when id is/was valid for use"/> <definition value="Time period during which identifier is/was valid for use."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.period"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.7 + CX.8"/> </mapping> <mapping> <identity value="rim"/> <map value="Role.effectiveTime or implied by context"/> </mapping> <mapping> <identity value="servd"/> <map value="./StartDate and ./EndDate"/> </mapping> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.assigner"> <path value="PackagedProductDefinition.identifier.assigner"/> <short value="Organization that issued id (may be just text)"/> <definition value="Organization that issued/manages the identifier."/> <comment value="The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization."/> <min value="0"/> <max value="1"/> <base> <path value="Identifier.assigner"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="CX.4 / (CX.4,CX.9,CX.10)"/> </mapping> <mapping> <identity value="rim"/> <map value="II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper"/> </mapping> <mapping> <identity value="servd"/> <map value="./IdentifierIssuingAuthority"/> </mapping> </element> <element id="PackagedProductDefinition.name"> <path value="PackagedProductDefinition.name"/> <short value="A name for this package. Typically as listed in a drug formulary, catalogue, inventory etc"/> <definition value="A name for this package. Typically what it would be listed as in a drug formulary or catalogue, inventory etc."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.name"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.type"> <path value="PackagedProductDefinition.type"/> <short value="A high level category e.g. medicinal product, raw material, shipping container etc"/> <definition value="A high level category e.g. medicinal product, raw material, shipping/transport container, etc."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="PackageType"/> </extension> <strength value="example"/> <description value="A high level categorisation of a package."/> <valueSet value="http://hl7.org/fhir/ValueSet/package-type"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packageFor"> <path value="PackagedProductDefinition.packageFor"/> <short value="The product that this is a pack for"/> <definition value="The product this package model relates to, not the contents of the package (for which see package.containedItem)."/> <min value="1"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packageFor"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-medicinalproductdefinition"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="(the link from Packaged Medicinal Product to Medicinal Product)"/> </mapping> </element> <element id="PackagedProductDefinition.status"> <path value="PackagedProductDefinition.status"/> <short value="The status within the lifecycle of this item. High level - not intended to duplicate details elsewhere e.g. legal status, or authorization/marketing status"/> <definition value="The status within the lifecycle of this item. A high level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization or marketing status."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.status"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="true"/> <isModifierReason value="This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="PublicationStatus"/> </extension> <strength value="preferred"/> <description value="The lifecycle status of an artifact."/> <valueSet value="http://hl7.org/fhir/ValueSet/publication-status"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.statusDate"> <path value="PackagedProductDefinition.statusDate"/> <short value="The date at which the given status became applicable"/> <definition value="The date at which the given status became applicable."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.statusDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.containedItemQuantity"> <path value="PackagedProductDefinition.containedItemQuantity"/> <short value="A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (size / weight of the package)"/> <definition value="A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. This attribute differs from containedItem.amount in that it can give a single aggregated count of all tablet types in a pack, even when these are different manufactured items. For example a pill pack of 21 tablets plus 7 sugar tablets, can be denoted here as '28 tablets'. This attribute is repeatable so that the different item types in one pack type can be counted (e.g. a count of vials and count of syringes). Each repeat must have different units, so that it is clear what the different sets of counted items are, and it is not intended to allow different counts of similar items (e.g. not '2 tubes and 3 tubes'). Repeats are not to be used to represent different pack sizes (e.g. 20 pack vs. 50 pack) - which would be different instances of this resource."/> <min value="1"/> <max value="1"/> <base> <path value="PackagedProductDefinition.containedItemQuantity"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Quantity"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.containedItemQuantity.id"> <path value="PackagedProductDefinition.containedItemQuantity.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.containedItemQuantity.extension"> <path value="PackagedProductDefinition.containedItemQuantity.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.containedItemQuantity.value"> <path value="PackagedProductDefinition.containedItemQuantity.value"/> <short value="Numerical value (with implicit precision)"/> <definition value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/> <comment value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/> <requirements value="Precision is handled implicitly in almost all cases of measurement."/> <min value="1"/> <max value="1"/> <base> <path value="Quantity.value"/> <min value="0"/> <max value="1"/> </base> <type> <code value="decimal"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="SN.2 / CQ - N/A"/> </mapping> <mapping> <identity value="rim"/> <map value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/> </mapping> </element> <element id="PackagedProductDefinition.containedItemQuantity.comparator"> <path value="PackagedProductDefinition.containedItemQuantity.comparator"/> <short value="< | <= | >= | > | ad - how to understand the value"/> <definition value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value."/> <requirements value="Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology."/> <min value="0"/> <max value="1"/> <base> <path value="Quantity.comparator"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <meaningWhenMissing value="If there is no comparator, then there is no modification of the value"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="QuantityComparator"/> </extension> <strength value="required"/> <description value="How the Quantity should be understood and represented."/> <valueSet value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/> </binding> <mapping> <identity value="v2"/> <map value="SN.1 / CQ.1"/> </mapping> <mapping> <identity value="rim"/> <map value="IVL properties"/> </mapping> </element> <element id="PackagedProductDefinition.containedItemQuantity.unit"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true"/> </extension> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true"/> </extension> <path value="PackagedProductDefinition.containedItemQuantity.unit"/> <short value="Unit representation"/> <definition value="A human-readable form of the unit."/> <requirements value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/> <min value="0"/> <max value="1"/> <base> <path value="Quantity.unit"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="(see OBX.6 etc.) / CQ.2"/> </mapping> <mapping> <identity value="rim"/> <map value="PQ.unit"/> </mapping> </element> <element id="PackagedProductDefinition.containedItemQuantity.system"> <path value="PackagedProductDefinition.containedItemQuantity.system"/> <short value="System that defines coded unit form"/> <definition value="The identification of the system that provides the coded form of the unit."/> <requirements value="Need to know the system that defines the coded form of the unit."/> <min value="1"/> <max value="1"/> <base> <path value="Quantity.system"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <condition value="qty-3"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="(see OBX.6 etc.) / CQ.2"/> </mapping> <mapping> <identity value="rim"/> <map value="CO.codeSystem, PQ.translation.codeSystem"/> </mapping> </element> <element id="PackagedProductDefinition.containedItemQuantity.code"> <path value="PackagedProductDefinition.containedItemQuantity.code"/> <short value="Coded form of the unit"/> <definition value="A computer processable form of the unit in some unit representation system."/> <comment value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system."/> <requirements value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/> <min value="1"/> <max value="1"/> <base> <path value="Quantity.code"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <condition value="qty-3"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="https://ema.europa.eu/fhir/vs/unitsOfPresentation"/> </binding> <mapping> <identity value="v2"/> <map value="(see OBX.6 etc.) / CQ.2"/> </mapping> <mapping> <identity value="rim"/> <map value="PQ.code, MO.currency, PQ.translation.code"/> </mapping> </element> <element id="PackagedProductDefinition.description"> <path value="PackagedProductDefinition.description"/> <short value="Textual description. Note that this is not the name of the package or product"/> <definition value="Textual description. Note that this is not the name of the package or product."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.description"/> <min value="0"/> <max value="1"/> </base> <type> <code value="markdown"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Packaged Medicinal Product.description"/> </mapping> </element> <element id="PackagedProductDefinition.legalStatusOfSupply"> <path value="PackagedProductDefinition.legalStatusOfSupply"/> <short value="The legal status of supply of the packaged item as classified by the regulator"/> <definition value="The legal status of supply of the packaged item as classified by the regulator."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.legalStatusOfSupply"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Legal Status of Supply (for a package)"/> </mapping> </element> <element id="PackagedProductDefinition.legalStatusOfSupply.id"> <path value="PackagedProductDefinition.legalStatusOfSupply.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.legalStatusOfSupply.extension"> <path value="PackagedProductDefinition.legalStatusOfSupply.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.legalStatusOfSupply.modifierExtension"> <path value="PackagedProductDefinition.legalStatusOfSupply.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="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."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="PackagedProductDefinition.legalStatusOfSupply.code"> <path value="PackagedProductDefinition.legalStatusOfSupply.code"/> <short value="The actual status of supply. In what situation this package type may be supplied for use"/> <definition value="The actual status of supply. Conveys in what situation this package type may be supplied for use."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.legalStatusOfSupply.code"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="LegalStatusOfSupply"/> </extension> <strength value="example"/> <description value="The prescription supply types appropriate to a medicinal product"/> <valueSet value="http://hl7.org/fhir/ValueSet/legal-status-of-supply"/> </binding> <mapping> <identity value="idmp"/> <map value="Marketing Authorization.Legal Status of Supply (for a package)"/> </mapping> </element> <element id="PackagedProductDefinition.legalStatusOfSupply.jurisdiction"> <path value="PackagedProductDefinition.legalStatusOfSupply.jurisdiction"/> <short value="The place where the legal status of supply applies"/> <definition value="The place where the legal status of supply applies. When not specified, this indicates it is unknown in this context."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.legalStatusOfSupply.jurisdiction"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="Jurisdiction"/> </extension> <strength value="example"/> <description value="Jurisdiction codes"/> <valueSet value="http://hl7.org/fhir/ValueSet/jurisdiction"/> </binding> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.marketingStatus"> <path value="PackagedProductDefinition.marketingStatus"/> <short value="Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated (delivery state of the package)"/> <definition value="Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated."/> <min value="1"/> <max value="1"/> <base> <path value="PackagedProductDefinition.marketingStatus"/> <min value="0"/> <max value="*"/> </base> <type> <code value="MarketingStatus"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Packaged Medicinal Product.Marketing Status"/> </mapping> </element> <element id="PackagedProductDefinition.marketingStatus.id"> <path value="PackagedProductDefinition.marketingStatus.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.marketingStatus.extension"> <path value="PackagedProductDefinition.marketingStatus.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.marketingStatus.modifierExtension"> <path value="PackagedProductDefinition.marketingStatus.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="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."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneType.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="PackagedProductDefinition.marketingStatus.country"> <path value="PackagedProductDefinition.marketingStatus.country"/> <short value="The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements"/> <definition value="The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements."/> <min value="0"/> <max value="1"/> <base> <path value="MarketingStatus.country"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="PackagedProductDefinition.marketingStatus.jurisdiction"> <path value="PackagedProductDefinition.marketingStatus.jurisdiction"/> <short value="Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified"/> <definition value="Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified."/> <min value="0"/> <max value="1"/> <base> <path value="MarketingStatus.jurisdiction"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="PackagedProductDefinition.marketingStatus.status"> <path value="PackagedProductDefinition.marketingStatus.status"/> <short value="This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples"/> <definition value="This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples."/> <min value="1"/> <max value="1"/> <base> <path value="MarketingStatus.status"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> <profile value="https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-codeableconcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="https://ema.europa.eu/fhir/vs/marketingStatus"/> </binding> </element> <element id="PackagedProductDefinition.marketingStatus.dateRange"> <path value="PackagedProductDefinition.marketingStatus.dateRange"/> <short value="The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain"/> <definition value="The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain."/> <min value="0"/> <max value="1"/> <base> <path value="MarketingStatus.dateRange"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Period"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="PackagedProductDefinition.marketingStatus.restoreDate"> <path value="PackagedProductDefinition.marketingStatus.restoreDate"/> <short value="The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain"/> <definition value="The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain."/> <min value="0"/> <max value="1"/> <base> <path value="MarketingStatus.restoreDate"/> <min value="0"/> <max value="1"/> </base> <type> <code value="dateTime"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> </element> <element id="PackagedProductDefinition.copackagedIndicator"> <path value="PackagedProductDefinition.copackagedIndicator"/> <short value="Identifies if the drug product is supplied with another item such as a diluent or adjuvant"/> <definition value="Identifies if the package contains different items, such as when a drug product is supplied with another item e.g. a diluent or adjuvant."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.copackagedIndicator"/> <min value="0"/> <max value="1"/> </base> <type> <code value="boolean"/> </type> <meaningWhenMissing value="If this value is not present, there is no statement being made about whether this is co-packaged or not. No inference can be made"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.manufacturer"> <path value="PackagedProductDefinition.manufacturer"/> <short value="Manufacturer of this package type (multiple means these are all possible manufacturers)"/> <definition value="Manufacturer of this package type. When there are multiple it means these are all possible manufacturers."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.manufacturer"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Packaged Medicinal Product.Manufacturer / Establishment (Organisation)"/> </mapping> </element> <element id="PackagedProductDefinition.attachedDocument"> <path value="PackagedProductDefinition.attachedDocument"/> <short value="Additional information or supporting documentation about the packaged product"/> <definition value="Additional information or supporting documentation about the packaged product."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.attachedDocument"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DocumentReference"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging"> <path value="PackagedProductDefinition.packaging"/> <short value="A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap"/> <definition value="A packaging item, as a container for medically related items, possibly with other packaging items within, or a packaging component, such as bottle cap (which is not a device or a medication manufactured item)."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packaging"/> <min value="0"/> <max value="1"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Packaged Medicinal Product.Package Item (Container), Package Item (Container).Package (Component)"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.id"> <path value="PackagedProductDefinition.packaging.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.extension"> <path value="PackagedProductDefinition.packaging.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.modifierExtension"> <path value="PackagedProductDefinition.packaging.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="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."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.identifier"> <path value="PackagedProductDefinition.packaging.identifier"/> <short value="An identifier that is specific to this particular part of the packaging. Including possibly a Data Carrier Identifier"/> <definition value="A business identifier that is specific to this particular part of the packaging, often assigned by the manufacturer. Including possibly Data Carrier Identifier (a GS1 barcode)."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.packaging.identifier"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Identifier"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Data Carrier Identifier"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.type"> <path value="PackagedProductDefinition.packaging.type"/> <short value="The physical type of the container of the items (package type container) (Presentation List)"/> <definition value="The physical type of the container of the items."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packaging.type"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> <profile value="https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-codeableconcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="https://ema.europa.eu/fhir/vs/packaging"/> </binding> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Package Item (Container) Type"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.componentPart"> <path value="PackagedProductDefinition.packaging.componentPart"/> <short value="Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial)"/> <definition value="Is this a part of the packaging (e.g. a cap or bottle stopper), rather than the packaging itself (e.g. a bottle or vial). The latter type are designed be a container, but the former are not."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packaging.componentPart"/> <min value="0"/> <max value="1"/> </base> <type> <code value="boolean"/> </type> <meaningWhenMissing value="If absent, it cannot be assumed that the item is packaging (a container) or a part of the packaging - it is just 'packaging'. Systems can sometimes infer this from the packaging.type (e.g. bottles are containers, bottle caps are not), or from the fact that a container will usually have other items within it (though it is possible that these exist but are not mentioned). Often the distinction is not critical - and can easily be understood by humans - but if that is necessary for machine processing it is recommended that this attribute is given a value."/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Whether this packaging item corresponds to an Package Item (Container), if false, or a Package (Component), when true"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.quantity"> <path value="PackagedProductDefinition.packaging.quantity"/> <short value="The quantity of this level of packaging in the package that contains it (with the outermost level being 1)"/> <definition value="The quantity of packaging items contained at this layer of the package. This does not relate to the number of contained items but relates solely to the number of packaging items. When looking at the outermost layer it is always 1. If there are two boxes within, at the next layer it would be 2."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packaging.quantity"/> <min value="0"/> <max value="1"/> </base> <type> <code value="integer"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Package Item (Container) Quantity"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.material"> <path value="PackagedProductDefinition.packaging.material"/> <short value="Material type of the package item"/> <definition value="Material type of the package item."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.packaging.material"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="PackageMaterial"/> </extension> <strength value="example"/> <description value="A material used in the construction of packages and their components."/> <valueSet value="http://hl7.org/fhir/ValueSet/package-material"/> </binding> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Material"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.alternateMaterial"> <path value="PackagedProductDefinition.packaging.alternateMaterial"/> <short value="A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material"/> <definition value="A possible alternate material for this part of the packaging, that is allowed to be used instead of the usual material (e.g. different types of plastic for a blister sleeve)."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.packaging.alternateMaterial"/> <min value="0"/> <max value="*"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="PackageMaterial"/> </extension> <strength value="example"/> <description value="A material used in the construction of packages and their components."/> <valueSet value="http://hl7.org/fhir/ValueSet/package-material"/> </binding> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Alternate Material"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.shelfLifeStorage"> <path value="PackagedProductDefinition.packaging.shelfLifeStorage"/> <short value="Shelf Life and storage information"/> <definition value="Shelf Life and storage information."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.packaging.shelfLifeStorage"/> <min value="0"/> <max value="*"/> </base> <type> <code value="ProductShelfLife"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Shelf Life / Storage"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.manufacturer"> <path value="PackagedProductDefinition.packaging.manufacturer"/> <short value="Manufacturer of this packaging item (multiple means these are all potential manufacturers)"/> <definition value="Manufacturer of this packaging item. When there are multiple values each one is a potential manufacturer of this packaging item."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.packaging.manufacturer"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Reference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/Organization"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Manufacturer / Establishment (Organisation)"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.property"> <path value="PackagedProductDefinition.packaging.property"/> <short value="General characteristics of this item"/> <definition value="General characteristics of this item."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.packaging.property"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Physical Characteristics"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.property.id"> <path value="PackagedProductDefinition.packaging.property.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.property.extension"> <path value="PackagedProductDefinition.packaging.property.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.property.modifierExtension"> <path value="PackagedProductDefinition.packaging.property.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="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."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.property.type"> <path value="PackagedProductDefinition.packaging.property.type"/> <short value="A code expressing the type of characteristic"/> <definition value="A code expressing the type of characteristic."/> <min value="1"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packaging.property.type"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="ProductCharacteristic"/> </extension> <strength value="example"/> <description value="This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set."/> <valueSet value="http://hl7.org/fhir/ValueSet/product-characteristic-codes"/> </binding> <mapping> <identity value="idmp"/> <map value="Physical Characteristics, all attributes"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.property.value[x]"> <path value="PackagedProductDefinition.packaging.property.value[x]"/> <short value="A value for the characteristic"/> <definition value="A value for the characteristic."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packaging.property.value[x]"/> <min value="0"/> <max value="1"/> </base> <type> <code value="CodeableConcept"/> </type> <type> <code value="Quantity"/> </type> <type> <code value="date"/> </type> <type> <code value="boolean"/> </type> <type> <code value="Attachment"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Physical Characteristics, attribute's value"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem"> <path value="PackagedProductDefinition.packaging.containedItem"/> <short value="The item(s) within the packaging"/> <definition value="The item(s) within the packaging."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.packaging.containedItem"/> <min value="0"/> <max value="*"/> </base> <type> <code value="BackboneElement"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Package Item (Container).Manufactured Item, Package Item (Container).Device"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.id"> <path value="PackagedProductDefinition.packaging.containedItem.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="string"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.extension"> <path value="PackagedProductDefinition.packaging.containedItem.extension"/> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.modifierExtension"> <path value="PackagedProductDefinition.packaging.containedItem.modifierExtension"/> <short value="Extensions that cannot be ignored even if unrecognized"/> <definition value="May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. 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. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself)."/> <comment value="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."/> <requirements value="Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension)."/> <alias value="extensions"/> <alias value="user content"/> <alias value="modifiers"/> <min value="0"/> <max value="*"/> <base> <path value="BackboneElement.modifierExtension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="true"/> <isModifierReason value="Modifier extensions are expected to modify the meaning or interpretation of the element that contains them"/> <isSummary value="true"/> <mapping> <identity value="rim"/> <map value="N/A"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.item"> <path value="PackagedProductDefinition.packaging.containedItem.item"/> <short value="The actual item(s) of medication, as manufactured, or a device, or other medically related item (food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package"/> <definition value="The actual item(s) of medication, as manufactured, or a device (typically, but not necessarily, a co-packaged one), or other medically related item (such as food, biologicals, raw materials, medical fluids, gases etc.), as contained in the package. This also allows another whole packaged product to be included, which is solely for the case where a package of other entire packages is wanted - such as a wholesale or distribution pack (for layers within one package, use PackagedProductDefinition.packaging.packaging)."/> <min value="1"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packaging.containedItem.item"/> <min value="1"/> <max value="1"/> </base> <type> <code value="CodeableReference"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/ManufacturedItemDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/DeviceDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/BiologicallyDerivedProduct"/> <targetProfile value="http://hl7.org/fhir/StructureDefinition/NutritionProduct"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="(the link to) Package Item (Container).Manufactured Item, Package Item (Container).Device"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount"> <path value="PackagedProductDefinition.packaging.containedItem.amount"/> <short value="The amount of the manufactured Item inside this packaging (E.g. Number of ml in a bottle). Not to be mistaken with the .containedItemQuantity which is the total presentable items in the package."/> <definition value="The number of this type of item within this packaging or for continuous items such as liquids it is the quantity (for example 25ml). See also PackagedProductDefinition.containedItemQuantity (especially the long definition)."/> <min value="0"/> <max value="1"/> <base> <path value="PackagedProductDefinition.packaging.containedItem.amount"/> <min value="0"/> <max value="1"/> </base> <type> <code value="Quantity"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="Manufactured Item.Manufactured Item Quantity"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.id"> <path value="PackagedProductDefinition.packaging.containedItem.amount.id"/> <representation value="xmlAttr"/> <short value="Unique id for inter-element referencing"/> <definition value="Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces."/> <min value="0"/> <max value="1"/> <base> <path value="Element.id"/> <min value="0"/> <max value="1"/> </base> <type> <extension url="http://hl7.org/fhir/StructureDefinition/structuredefinition-fhir-type"> <valueUrl value="id"/> </extension> <code value="http://hl7.org/fhirpath/System.String"/> </type> <condition value="ele-1"/> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.extension"> <path value="PackagedProductDefinition.packaging.containedItem.amount.extension"/> <slicing> <discriminator> <type value="value"/> <path value="url"/> </discriminator> <description value="Extensions are always sliced by (at least) url"/> <rules value="open"/> </slicing> <short value="Additional content defined by implementations"/> <definition value="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."/> <comment value="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."/> <alias value="extensions"/> <alias value="user content"/> <min value="0"/> <max value="*"/> <base> <path value="Element.extension"/> <min value="0"/> <max value="*"/> </base> <type> <code value="Extension"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <constraint> <key value="ext-1"/> <severity value="error"/> <human value="Must have either extensions or value[x], not both"/> <expression value="extension.exists() != value.exists()"/> <source value="http://hl7.org/fhir/StructureDefinition/Extension"/> </constraint> <isModifier value="false"/> <isSummary value="false"/> <mapping> <identity value="rim"/> <map value="n/a"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.value"> <path value="PackagedProductDefinition.packaging.containedItem.amount.value"/> <short value="Numerical value (with implicit precision)"/> <definition value="The value of the measured amount. The value includes an implicit precision in the presentation of the value."/> <comment value="The implicit precision in the value should always be honored. Monetary values have their own rules for handling precision (refer to standard accounting text books)."/> <requirements value="Precision is handled implicitly in almost all cases of measurement."/> <min value="1"/> <max value="1"/> <base> <path value="Quantity.value"/> <min value="0"/> <max value="1"/> </base> <type> <code value="decimal"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="SN.2 / CQ - N/A"/> </mapping> <mapping> <identity value="rim"/> <map value="PQ.value, CO.value, MO.value, IVL.high or IVL.low depending on the value"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.comparator"> <path value="PackagedProductDefinition.packaging.containedItem.amount.comparator"/> <short value="< | <= | >= | > | ad - how to understand the value"/> <definition value="How the value should be understood and represented - whether the actual value is greater or less than the stated value due to measurement issues; e.g. if the comparator is "<" , then the real value is < stated value."/> <requirements value="Need a framework for handling measures where the value is <5ug/L or >400mg/L due to the limitations of measuring methodology."/> <min value="0"/> <max value="1"/> <base> <path value="Quantity.comparator"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <meaningWhenMissing value="If there is no comparator, then there is no modification of the value"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="true"/> <isModifierReason value="This is labeled as "Is Modifier" because the comparator modifies the interpretation of the value significantly. If there is no comparator, then there is no modification of the value"/> <isSummary value="true"/> <binding> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-bindingName"> <valueString value="QuantityComparator"/> </extension> <strength value="required"/> <description value="How the Quantity should be understood and represented."/> <valueSet value="http://hl7.org/fhir/ValueSet/quantity-comparator|5.0.0"/> </binding> <mapping> <identity value="v2"/> <map value="SN.1 / CQ.1"/> </mapping> <mapping> <identity value="rim"/> <map value="IVL properties"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.unit"> <extension url="http://hl7.org/fhir/StructureDefinition/elementdefinition-translatable"> <valueBoolean value="true"/> </extension> <path value="PackagedProductDefinition.packaging.containedItem.amount.unit"/> <short value="Unit representation"/> <definition value="A human-readable form of the unit."/> <requirements value="There are many representations for units of measure and in many contexts, particular representations are fixed and required. I.e. mcg for micrograms."/> <min value="1"/> <max value="1"/> <base> <path value="Quantity.unit"/> <min value="0"/> <max value="1"/> </base> <type> <code value="string"/> </type> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="(see OBX.6 etc.) / CQ.2"/> </mapping> <mapping> <identity value="rim"/> <map value="PQ.unit"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.system"> <path value="PackagedProductDefinition.packaging.containedItem.amount.system"/> <short value="System that defines coded unit form"/> <definition value="The identification of the system that provides the coded form of the unit."/> <requirements value="Need to know the system that defines the coded form of the unit."/> <min value="1"/> <max value="1"/> <base> <path value="Quantity.system"/> <min value="0"/> <max value="1"/> </base> <type> <code value="uri"/> </type> <condition value="qty-3"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="v2"/> <map value="(see OBX.6 etc.) / CQ.2"/> </mapping> <mapping> <identity value="rim"/> <map value="CO.codeSystem, PQ.translation.codeSystem"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.code"> <path value="PackagedProductDefinition.packaging.containedItem.amount.code"/> <short value="Coded form of the unit"/> <definition value="A computer processable form of the unit in some unit representation system."/> <comment value="The preferred system is UCUM, but SNOMED CT can also be used (for customary units) or ISO 4217 for currency. The context of use may additionally require a code from a particular system."/> <requirements value="Need a computable form of the unit that is fixed across all forms. UCUM provides this for quantities, but SNOMED CT provides many units of interest."/> <min value="1"/> <max value="1"/> <base> <path value="Quantity.code"/> <min value="0"/> <max value="1"/> </base> <type> <code value="code"/> </type> <condition value="qty-3"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <isModifier value="false"/> <isSummary value="true"/> <binding> <strength value="required"/> <valueSet value="https://ema.europa.eu/fhir/vs/unitsOfMeasurement"/> </binding> <mapping> <identity value="v2"/> <map value="(see OBX.6 etc.) / CQ.2"/> </mapping> <mapping> <identity value="rim"/> <map value="PQ.code, MO.currency, PQ.translation.code"/> </mapping> </element> <element id="PackagedProductDefinition.packaging.packaging"> <path value="PackagedProductDefinition.packaging.packaging"/> <short value="In order to add more package types, additional packagings must be added first with a reference to the packaging it is included in. "/> <definition value="Allows containers (and parts of containers) within containers, still as a part of a single packaged product. See also PackagedProductDefinition.packaging.containedItem.item(PackagedProductDefinition)."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.packaging.packaging"/> <min value="0"/> <max value="*"/> </base> <contentReference value="http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="(link from Package Item (Container) to itself)"/> </mapping> </element> <element id="PackagedProductDefinition.characteristic"> <path value="PackagedProductDefinition.characteristic"/> <short value="Allows the key features to be recorded, such as "hospital pack", "nurse prescribable""/> <definition value="Allows the key features to be recorded, such as "hospital pack", "nurse prescribable", "calendar pack"."/> <min value="0"/> <max value="*"/> <base> <path value="PackagedProductDefinition.characteristic"/> <min value="0"/> <max value="*"/> </base> <contentReference value="http://hl7.org/fhir/StructureDefinition/PackagedProductDefinition#PackagedProductDefinition.packaging.property"/> <constraint> <key value="ele-1"/> <severity value="error"/> <human value="All FHIR elements must have a @value or children"/> <expression value="hasValue() or (children().count() > id.count())"/> <source value="http://hl7.org/fhir/StructureDefinition/Element"/> </constraint> <mustSupport value="false"/> <isModifier value="false"/> <isSummary value="true"/> <mapping> <identity value="idmp"/> <map value="n/a"/> </mapping> </element> </snapshot> <differential> <element id="PackagedProductDefinition"> <path value="PackagedProductDefinition"/> </element> <element id="PackagedProductDefinition.identifier"> <path value="PackagedProductDefinition.identifier"/> <slicing> <discriminator> <type value="value"/> <path value="system"/> </discriminator> <description value="The package has the ID PZN as well as a Pharos ID from the Austrian Agency"/> <ordered value="false"/> <rules value="open"/> </slicing> <short value="A unique identifier for this package as whole - not for the content of the package (pharmaceutical registration number (Pharmazentralnummer (PZN)))"/> <min value="2"/> <type> <code value="Identifier"/> <profile value="https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-identifier"/> </type> </element> <element id="PackagedProductDefinition.identifier:PZN"> <path value="PackagedProductDefinition.identifier"/> <sliceName value="PZN"/> <min value="1"/> <max value="1"/> </element> <element id="PackagedProductDefinition.identifier:PZN.system"> <path value="PackagedProductDefinition.identifier.system"/> <patternUri value="https://argepharma.fcio.at"/> </element> <element id="PackagedProductDefinition.identifier:referenceNumber"> <path value="PackagedProductDefinition.identifier"/> <sliceName value="referenceNumber"/> <min value="1"/> <max value="1"/> </element> <element id="PackagedProductDefinition.identifier:referenceNumber.system"> <path value="PackagedProductDefinition.identifier.system"/> <patternUri value="https://www.ages.at/fhir/referenceNumber"/> </element> <element id="PackagedProductDefinition.packageFor"> <path value="PackagedProductDefinition.packageFor"/> <min value="1"/> <max value="1"/> <type> <code value="Reference"/> <targetProfile value="https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-medicinalproductdefinition"/> </type> </element> <element id="PackagedProductDefinition.containedItemQuantity"> <path value="PackagedProductDefinition.containedItemQuantity"/> <short value="A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (size / weight of the package)"/> <min value="1"/> <max value="1"/> </element> <element id="PackagedProductDefinition.containedItemQuantity.value"> <path value="PackagedProductDefinition.containedItemQuantity.value"/> <min value="1"/> </element> <element id="PackagedProductDefinition.containedItemQuantity.system"> <path value="PackagedProductDefinition.containedItemQuantity.system"/> <min value="1"/> </element> <element id="PackagedProductDefinition.containedItemQuantity.code"> <path value="PackagedProductDefinition.containedItemQuantity.code"/> <min value="1"/> <binding> <strength value="required"/> <valueSet value="https://ema.europa.eu/fhir/vs/unitsOfPresentation"/> </binding> </element> <element id="PackagedProductDefinition.marketingStatus"> <path value="PackagedProductDefinition.marketingStatus"/> <short value="Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated (delivery state of the package)"/> <min value="1"/> <max value="1"/> </element> <element id="PackagedProductDefinition.marketingStatus.status"> <path value="PackagedProductDefinition.marketingStatus.status"/> <type> <code value="CodeableConcept"/> <profile value="https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-codeableconcept"/> </type> <binding> <strength value="required"/> <valueSet value="https://ema.europa.eu/fhir/vs/marketingStatus"/> </binding> </element> <element id="PackagedProductDefinition.packaging.type"> <path value="PackagedProductDefinition.packaging.type"/> <short value="The physical type of the container of the items (package type container) (Presentation List)"/> <type> <code value="CodeableConcept"/> <profile value="https://www.ages.at/fhir/medicinalproduct/StructureDefinition/at-medprod-codeableconcept"/> </type> <binding> <strength value="required"/> <valueSet value="https://ema.europa.eu/fhir/vs/packaging"/> </binding> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount"> <path value="PackagedProductDefinition.packaging.containedItem.amount"/> <short value="The amount of the manufactured Item inside this packaging (E.g. Number of ml in a bottle). Not to be mistaken with the .containedItemQuantity which is the total presentable items in the package."/> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.value"> <path value="PackagedProductDefinition.packaging.containedItem.amount.value"/> <min value="1"/> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.unit"> <path value="PackagedProductDefinition.packaging.containedItem.amount.unit"/> <min value="1"/> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.system"> <path value="PackagedProductDefinition.packaging.containedItem.amount.system"/> <min value="1"/> </element> <element id="PackagedProductDefinition.packaging.containedItem.amount.code"> <path value="PackagedProductDefinition.packaging.containedItem.amount.code"/> <min value="1"/> <binding> <strength value="required"/> <valueSet value="https://ema.europa.eu/fhir/vs/unitsOfMeasurement"/> </binding> </element> <element id="PackagedProductDefinition.packaging.packaging"> <path value="PackagedProductDefinition.packaging.packaging"/> <short value="In order to add more package types, additional packagings must be added first with a reference to the packaging it is included in. "/> </element> </differential> </StructureDefinition>

Generated Narrative: StructureDefinition at-medprod-packagedproductdefinition

Name	Card.	Type	Description & Constraints
PackagedProductDefinition	0..*	PackagedProductDefinition	A medically related item or items, in a container or package
Slices for identifier	2..*	AT_MedicinalProduct_Identifier	A unique identifier for this package as whole - not for the content of the package (pharmaceutical registration number (Pharmazentralnummer (PZN))) Slice: Unordered, Open by value:system
identifier:PZN	1..1	Identifier	A unique identifier for this package as whole - not for the content of the package
system	0..1	uri	The namespace for the identifier value Required Pattern: https://argepharma.fcio.at
identifier:referenceNumber	1..1	Identifier	A unique identifier for this package as whole - not for the content of the package
system	0..1	uri	The namespace for the identifier value Required Pattern: https://www.ages.at/fhir/referenceNumber
packageFor	1..1	Reference(Medicinal Product Definition)	The product that this is a pack for
containedItemQuantity	1..1	Quantity	A total of the complete count of contained items of a particular type/form, independent of sub-packaging or organization. This can be considered as the pack size. See also packaging.containedItem.amount (size / weight of the package)
value	1..1	decimal	Numerical value (with implicit precision)
system	1..1	uri	System that defines coded unit form
code	1..1	code	Coded form of the unit Binding: The Units of Presentation Value Set (required)
marketingStatus	1..1	MarketingStatus	Allows specifying that an item is on the market for sale, or that it is not available, and the dates and locations associated (delivery state of the package)
status	1..1	AT_MedicinalProduct_CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: The Marketing Status value Set (required)
packaging
type	0..1	AT_MedicinalProduct_CodeableConcept	The physical type of the container of the items (package type container) (Presentation List) Binding: The Packaging Value Set (required)
containedItem
amount	0..1	Quantity	The amount of the manufactured Item inside this packaging (E.g. Number of ml in a bottle). Not to be mistaken with the .containedItemQuantity which is the total presentable items in the package.
value	1..1	decimal	Numerical value (with implicit precision)
unit	1..1	string	Unit representation
system	1..1	uri	System that defines coded unit form
code	1..1	code	Coded form of the unit Binding: The Units of Measurement Value Set (required)
packaging	0..*		In order to add more package types, additional packagings must be added first with a reference to the packaging it is included in.
Documentation for this format