EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

Resource Profile: EmaWriteApiRegulatedAuthorization - Detailed Descriptions

Draft as of 2025-04-04

Definitions for the emaWriteApiRegulatedAuthorization resource profile.

Guidance on how to interpret the contents of this table can be found here

0. RegulatedAuthorization
Definition

Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.

ShortRegulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Control0..*
Is Modifierfalse
Must Supportfalse
Summaryfalse
Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
dom-3: 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 (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())
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
dom-6: A resource should have narrative for robust management (text.`div`.exists())
regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory ((type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists())
2. RegulatedAuthorization.implicitRules
Definition

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.

ShortA set of rules under which this content was created
Comments

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.

Control0..1
Typeuri
Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
Must Supportfalse
Summarytrue
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
4. RegulatedAuthorization.contained
Definition

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.

ShortContained, inline Resources
Comments

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.

Control0..*
This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
TypeResource
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesinline resources, anonymous resources, contained resources
6. RegulatedAuthorization.extension
Definition

An Extension


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.

ShortExtensionAdditional content defined by implementations
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Control0..*
TypeExtension
Is Modifierfalse
Must Supportfalse
Summaryfalse
Alternate Namesextensions, user content
Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
SlicingThis element introduces a set of slices on RegulatedAuthorization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
  • value @ url
  • 8. RegulatedAuthorization.extension:dateOfFirstAuthorisation
    Slice NamedateOfFirstAuthorisation
    Definition

    The Regulated Authorization's Date of First Authorisation

    ShortRegulated Authorization - Date of First Authorisation
    Control0..1
    TypeExtension(Regulated Authorization - Date of First Authorisation) (Extension Type: date)
    Is Modifierfalse
    Must Supportfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    10. RegulatedAuthorization.extension:internationalBirthDate
    Slice NameinternationalBirthDate
    Definition

    The Regulated Authorization's International Birth Date

    ShortRegulated Authorization - International Birth Date
    Control0..1
    TypeExtension(Regulated Authorization - International Birth Date) (Extension Type: date)
    Is Modifierfalse
    Must Supportfalse
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    12. RegulatedAuthorization.modifierExtension
    Definition

    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).

    ShortExtensions that cannot be ignored
    Comments

    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

    Control0..*
    TypeExtension
    Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
    Must Supportfalse
    Summarytrue
    Requirements

    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.

    Alternate Namesextensions, user content
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
    14. RegulatedAuthorization.identifier
    Definition

    Business identifier for the authorization, typically assigned by the authorizing body.

    ShortBusiness identifier for the authorization, typically assigned by the authorizing body
    NoteThis is a business identifier, not a resource identifier (see discussion)
    Control0..1*
    TypeIdentifier
    Is Modifierfalse
    Must Supportfalse
    Summarytrue
    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
    SlicingThis element introduces a set of slices on RegulatedAuthorization.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
    • value @ system
    • 16. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier
      Slice NamemarketingAuthorizationIdentifier
      Definition

      Business identifier for the authorization, typically assigned by the authorizing body.

      ShortBusiness identifier for the authorization, typically assigned by the authorizing body
      NoteThis is a business identifier, not a resource identifier (see discussion)
      Control0..1*
      TypeIdentifier(EMA Marketing Authorization Identifier)
      Is Modifierfalse
      Must Supportfalse
      Summarytrue
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      18. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.extension
      Definition

      An Extension


      May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

      ShortExtensionAdditional content defined by implementations
      Comments

      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

      Control0..0*
      TypeExtension
      Is Modifierfalse
      Summaryfalse
      Alternate Namesextensions, user content
      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
      SlicingThis element introduces a set of slices on RegulatedAuthorization.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
      • value @ url
      • 20. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.use
        Definition

        The purpose of this identifier.

        Shortusual | official | temp | secondary | old (If known)
        Comments

        Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

        Control0..01
        BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
        (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

        Identifies the purpose for this identifier, if known .

        Typecode
        Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        22. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.type
        Definition

        A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

        ShortDescription of identifier
        Comments

        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.

        Control0..01
        BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type
        (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

        A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

        TypeCodeableConcept
        Is Modifierfalse
        Summarytrue
        Requirements

        Allows users to make use of identifiers when the identifier system is not known.

        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        24. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.system
        Definition

        Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

        ShortThe namespace for the identifier value
        Comments

        Identifier.system is always case sensitive.

        Control10..1
        Typeuri
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Requirements

        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.

        Pattern Valuehttp://ema.europa.eu/fhir/marketingAuthorizationNumber
        Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        26. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.value
        Definition

        The portion of the identifier typically relevant to the user and which is unique within the context of the system.

        ShortThe value that is unique
        Comments

        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). 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.

        Control10..1
        This element is affected by the following invariants: ident-1
        Typestring
        Is Modifierfalse
        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
        Summarytrue
        Example<br/><b>General</b>:123456
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        28. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.period
        Definition

        Time period during which identifier is/was valid for use.

        ShortTime period when id is/was valid for use
        Control0..01
        TypePeriod
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        30. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.assigner
        Definition

        Organization that issued/manages the identifier.

        ShortOrganization that issued id (may be just text)
        Comments

        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.

        Control0..01
        TypeReference(Organization)
        Is Modifierfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        32. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier
        Slice NamemanufacturingAuthorizationNumberIdentifier
        Definition

        Business identifier for the authorization, typically assigned by the authorizing body.

        ShortBusiness identifier for the authorization, typically assigned by the authorizing body
        NoteThis is a business identifier, not a resource identifier (see discussion)
        Control0..1*
        TypeIdentifier(EMA Manufacturing Authorization Number Identifier)
        Is Modifierfalse
        Must Supportfalse
        Summarytrue
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        34. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.extension
        Definition

        An Extension


        May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

        ShortExtensionAdditional content defined by implementations
        Comments

        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

        Control0..0*
        TypeExtension
        Is Modifierfalse
        Summaryfalse
        Alternate Namesextensions, user content
        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
        SlicingThis element introduces a set of slices on RegulatedAuthorization.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
        • value @ url
        • 36. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.use
          Definition

          The purpose of this identifier.

          Shortusual | official | temp | secondary | old (If known)
          Comments

          Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

          Control0..01
          BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
          (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

          Identifies the purpose for this identifier, if known .

          Typecode
          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          38. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.type
          Definition

          A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

          ShortDescription of identifier
          Comments

          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.

          Control0..01
          BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodeshttp://hl7.org/fhir/ValueSet/identifier-type
          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

          A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

          TypeCodeableConcept
          Is Modifierfalse
          Summarytrue
          Requirements

          Allows users to make use of identifiers when the identifier system is not known.

          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          40. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.system
          Definition

          Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

          ShortThe namespace for the identifier value
          Comments

          Identifier.system is always case sensitive.

          Control10..1
          Typeuri
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Requirements

          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.

          Pattern Valuehttp://ema.europa.eu/fhir/manufacturingAuthorizationNumber
          Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          42. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.value
          Definition

          The portion of the identifier typically relevant to the user and which is unique within the context of the system.

          ShortThe value that is unique
          Comments

          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). 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.

          Control10..1
          This element is affected by the following invariants: ident-1
          Typestring
          Is Modifierfalse
          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
          Summarytrue
          Example<br/><b>General</b>:123456
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          44. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.period
          Definition

          Time period during which identifier is/was valid for use.

          ShortTime period when id is/was valid for use
          Control0..01
          TypePeriod
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          46. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.assigner
          Definition

          Organization that issued/manages the identifier.

          ShortOrganization that issued id (may be just text)
          Comments

          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.

          Control0..01
          TypeReference(Organization)
          Is Modifierfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          48. RegulatedAuthorization.subject
          Definition

          The product type, treatment, facility or activity that is being authorized.

          ShortThe product type, treatment, facility or activity that is being authorized
          Control10..1*
          TypeReference(EMA Write API MedicinalProductDefinition, EMA Write API PackagedProductDefinition, EMA Write API ActivityDefinition, MedicinalProductDefinition, BiologicallyDerivedProduct, NutritionProduct, PackagedProductDefinition, ManufacturedItemDefinition, Ingredient, SubstanceDefinition, DeviceDefinition, ResearchStudy, ActivityDefinition, PlanDefinition, ObservationDefinition, Practitioner, Organization, Location)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          50. RegulatedAuthorization.type
          Definition

          Overall type of this authorization, for example drug marketing approval, orphan drug designation.

          ShortOverall type of this authorization, for example drug marketing approval, orphan drug designation
          Control10..1
          BindingThe codes SHALL be taken from For example codes, see Regulatory Entitlement Typehttp://hl7.org/fhir/ValueSet/regulated-authorization-type
          (required to http://ema.europa.eu/fhir/vs/regulatoryEntitlementType)
          TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
          Is Modifierfalse
          Must Supportfalse
          Summarytrue
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          52. RegulatedAuthorization.type.extension
          Definition

          An Extension


          May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

          ShortExtensionAdditional content defined by implementations
          Comments

          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

          Control0..0*
          TypeExtension
          Is Modifierfalse
          Summaryfalse
          Alternate Namesextensions, user content
          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
          SlicingThis element introduces a set of slices on RegulatedAuthorization.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
          • value @ url
          • 54. RegulatedAuthorization.type.coding
            Definition

            A reference to a code defined by a terminology system.

            ShortCode defined by a terminology system
            Comments

            Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

            Control10..1*
            BindingThe codes SHALL be taken from For codes, see Marketing and Manufacturing types
            (required to http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes)
            TypeCoding(EMA Coding)
            Is Modifierfalse
            Summarytrue
            Requirements

            Allows for alternative encodings within a code system, and translations to other code systems.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            56. RegulatedAuthorization.type.text
            Definition

            A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

            ShortPlain text representation of the concept
            Comments

            Very often the text is the same as a displayName of one of the codings.

            Control0..01
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            58. RegulatedAuthorization.status
            Definition

            The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.

            ShortThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
            Control10..1
            BindingThe codes SHALL be taken from The codes SHOULD be taken from Regulatory Entitlement Statushttp://hl7.org/fhir/ValueSet/publication-status
            (required to http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus)
            TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            60. RegulatedAuthorization.holder
            Definition

            The organization that has been granted this authorization, by some authoritative body (the 'regulator').

            ShortThe organization that has been granted this authorization, by the regulator
            Control10..1
            TypeReference(Organization)
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            62. RegulatedAuthorization.holder.reference
            Definition

            A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

            ShortLiteral reference, Relative, internal or absolute URL
            Comments

            Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

            Control0..1
            This element is affected by the following invariants: ref-2, ref-1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            64. RegulatedAuthorization.holder.identifier
            Definition

            An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

            ShortLogical reference, when literal reference is not known
            Comments

            When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

            When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

            Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

            Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

            This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.

            NoteThis is a business identifier, not a resource identifier (see discussion)
            Control10..1
            This element is affected by the following invariants: ref-2
            TypeIdentifier
            Is Modifierfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            66. RegulatedAuthorization.holder.identifier.use
            Definition

            The purpose of this identifier.

            Shortusual | official | temp | secondary | old (If known)
            Comments

            Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

            Control0..1
            BindingThe codes SHALL be taken from IdentifierUsehttp://hl7.org/fhir/ValueSet/identifier-use|5.0.0
            (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

            Identifies the purpose for this identifier, if known .

            Typecode
            Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            68. RegulatedAuthorization.holder.identifier.system
            Definition

            Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

            ShortThe namespace for the identifier value
            Comments

            Identifier.system is always case sensitive.

            Control10..1
            Typeuri
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Requirements

            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.

            Pattern Valuehttps://spor.ema.europa.eu/v1/locations
            Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            70. RegulatedAuthorization.holder.identifier.value
            Definition

            The portion of the identifier typically relevant to the user and which is unique within the context of the system.

            ShortThe value that is unique
            Comments

            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). 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.

            Control10..1
            This element is affected by the following invariants: ident-1
            Typestring
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Summarytrue
            Example<br/><b>General</b>:123456
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            72. RegulatedAuthorization.case
            Definition

            The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).

            ShortThe case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
            Control10..1
            TypeBackboneElement
            Is Modifierfalse
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            74. RegulatedAuthorization.case.extension
            Definition

            The Paediatric Regulated Authorization's Reference Country


            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.

            ShortRegulated Authorization - Paediatric - Reference Country
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control1..1
            TypeExtension(Regulated Authorization - Paediatric - Reference Country) (Extension Type: Coding(EMA Coding))
            Is Modifierfalse
            Alternate Namesextensions, user content
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            76. RegulatedAuthorization.case.modifierExtension
            Definition

            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).

            ShortExtensions that cannot be ignored even if unrecognized
            Comments

            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

            Control0..*
            TypeExtension
            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
            Summarytrue
            Requirements

            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.

            Alternate Namesextensions, user content, modifiers
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
            78. RegulatedAuthorization.case.date[x]
            Definition

            Relevant date for this case.

            ShortRelevant date for this case
            Control0..1
            TypeChoice of: Period, dateTime
            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
            Is Modifierfalse
            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
            Must Supportfalse
            Summarytrue
            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
            SlicingThis element introduces a set of slices on RegulatedAuthorization.case.date[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
            • type @ $this
            • 80. RegulatedAuthorization.case.date[x]:datePeriod
              Slice NamedatePeriod
              Definition

              Relevant date for this case.

              ShortRelevant date for this case
              Control0..1
              TypePeriod, dateTime
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              82. RegulatedAuthorization.case.application
              Definition

              A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.

              ShortApplications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
              Control0..1*
              TypeBackboneElement
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              84. RegulatedAuthorization.case.application.modifierExtension
              Definition

              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).

              ShortExtensions that cannot be ignored even if unrecognized
              Comments

              There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

              Control0..*
              TypeExtension
              Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
              Summarytrue
              Requirements

              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.

              Alternate Namesextensions, user content, modifiers
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
              86. RegulatedAuthorization.case.application.identifier
              Definition

              Identifier by which this case can be referenced.

              ShortIdentifier by which this case can be referenced
              NoteThis is a business identifier, not a resource identifier (see discussion)
              Control0..1
              TypeIdentifier(EMA Application Identifier Number)
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              88. RegulatedAuthorization.case.application.type
              Definition

              The defining type of case.

              ShortThe defining type of case
              Control0..1
              BindingThe codes SHALL be taken from For example codes, see Application Submission Typehttp://hl7.org/fhir/ValueSet/regulated-authorization-case-type
              (required to http://ema.europa.eu/fhir/vs/applicationSubmissionType)
              TypeCodeableConcept
              Is Modifierfalse
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              90. RegulatedAuthorization.case.application.date[x]
              Definition

              Relevant date for this case.

              ShortRelevant date for this case
              Control10..1
              TypedateTime, Period
              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
              Is Modifierfalse
              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
              Must Supportfalse
              Summarytrue
              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
              SlicingThis element introduces a set of slices on RegulatedAuthorization.case.application.date[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
              • type @ $this
              • 92. RegulatedAuthorization.case.application.date[x]:dateDateTime
                Slice NamedateDateTime
                Definition

                Relevant date for this case.

                ShortRelevant date for this case
                Control10..1
                TypedateTime, Period
                [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                Is Modifierfalse
                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                Must Supportfalse
                Summarytrue
                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))

                Guidance on how to interpret the contents of this table can be found here

                0. RegulatedAuthorization
                InvariantsregulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory ((type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists())
                2. RegulatedAuthorization.extension
                SlicingThis element introduces a set of slices on RegulatedAuthorization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                • value @ url
                • 4. RegulatedAuthorization.extension:dateOfFirstAuthorisation
                  Slice NamedateOfFirstAuthorisation
                  Control0..1
                  TypeExtension(Regulated Authorization - Date of First Authorisation) (Extension Type: date)
                  6. RegulatedAuthorization.extension:internationalBirthDate
                  Slice NameinternationalBirthDate
                  Control0..1
                  TypeExtension(Regulated Authorization - International Birth Date) (Extension Type: date)
                  8. RegulatedAuthorization.identifier
                  NoteThis is a business identifier, not a resource identifier (see discussion)
                  Control0..1
                  SlicingThis element introduces a set of slices on RegulatedAuthorization.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                  • value @ system
                  • 10. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier
                    Slice NamemarketingAuthorizationIdentifier
                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control0..1
                    TypeIdentifier(EMA Marketing Authorization Identifier)
                    12. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.system
                    Control1..?
                    Pattern Valuehttp://ema.europa.eu/fhir/marketingAuthorizationNumber
                    14. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier
                    Slice NamemanufacturingAuthorizationNumberIdentifier
                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control0..1
                    TypeIdentifier(EMA Manufacturing Authorization Number Identifier)
                    16. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.system
                    Control1..?
                    Pattern Valuehttp://ema.europa.eu/fhir/manufacturingAuthorizationNumber
                    18. RegulatedAuthorization.subject
                    Control1..1
                    TypeReference(EMA Write API MedicinalProductDefinition, EMA Write API PackagedProductDefinition, EMA Write API ActivityDefinition)
                    20. RegulatedAuthorization.type
                    Control1..?
                    BindingThe codes SHALL be taken from Regulatory Entitlement Type
                    (required to http://ema.europa.eu/fhir/vs/regulatoryEntitlementType)
                    TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                    22. RegulatedAuthorization.type.coding
                    BindingThe codes SHALL be taken from Marketing and Manufacturing types
                    (required to http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes)
                    24. RegulatedAuthorization.status
                    Control1..?
                    BindingThe codes SHALL be taken from Regulatory Entitlement Status
                    (required to http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus)
                    TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                    26. RegulatedAuthorization.holder
                    Control1..?
                    28. RegulatedAuthorization.holder.identifier
                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    Control1..?
                    30. RegulatedAuthorization.holder.identifier.system
                    Control1..?
                    Pattern Valuehttps://spor.ema.europa.eu/v1/locations
                    32. RegulatedAuthorization.holder.identifier.value
                    Control1..?
                    34. RegulatedAuthorization.regulator
                    36. RegulatedAuthorization.regulator.identifier
                    NoteThis is a business identifier, not a resource identifier (see discussion)
                    38. RegulatedAuthorization.regulator.identifier.system
                    Control1..?
                    Pattern Valuehttps://spor.ema.europa.eu/v1/locations
                    40. RegulatedAuthorization.regulator.identifier.value
                    Control1..?
                    42. RegulatedAuthorization.case
                    Control1..?
                    44. RegulatedAuthorization.case.extension
                    Definition

                    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.

                    Comments

                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                    Control1..1
                    TypeExtension(Regulated Authorization - Paediatric - Reference Country) (Extension Type: Coding(EMA Coding))
                    Alternate Namesextensions, user content
                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                    46. RegulatedAuthorization.case.date[x]
                    [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                    SlicingThis element introduces a set of slices on RegulatedAuthorization.case.date[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                    • type @ $this
                    • 48. RegulatedAuthorization.case.date[x]:datePeriod
                      Slice NamedatePeriod
                      Control0..1
                      TypePeriod
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      50. RegulatedAuthorization.case.application
                      Control0..1
                      TypeBackboneElement
                      52. RegulatedAuthorization.case.application.identifier
                      NoteThis is a business identifier, not a resource identifier (see discussion)
                      TypeIdentifier(EMA Application Identifier Number)
                      54. RegulatedAuthorization.case.application.type
                      BindingThe codes SHALL be taken from Application Submission Type
                      (required to http://ema.europa.eu/fhir/vs/applicationSubmissionType)
                      56. RegulatedAuthorization.case.application.date[x]
                      Control1..?
                      [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                      SlicingThis element introduces a set of slices on RegulatedAuthorization.case.application.date[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                      • type @ $this
                      • 58. RegulatedAuthorization.case.application.date[x]:dateDateTime
                        Slice NamedateDateTime
                        Control1..1
                        TypedateTime
                        [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension

                        Guidance on how to interpret the contents of this table can be found here

                        0. RegulatedAuthorization
                        Definition

                        Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.

                        ShortRegulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
                        Control0..*
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Invariantsdom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources (contained.contained.empty())
                        dom-3: 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 (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())
                        dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated (contained.meta.versionId.empty() and contained.meta.lastUpdated.empty())
                        dom-5: If a resource is contained in another resource, it SHALL NOT have a security label (contained.meta.security.empty())
                        dom-6: A resource should have narrative for robust management (text.`div`.exists())
                        regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory ((type.coding.code = '220000000099' and identifier.exists()) implies regulator.exists())
                        2. RegulatedAuthorization.id
                        Definition

                        The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.

                        ShortLogical id of this artifact
                        Comments

                        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.

                        Control0..1
                        Typeid
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        4. RegulatedAuthorization.meta
                        Definition

                        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.

                        ShortMetadata about the resource
                        Control0..1
                        TypeMeta
                        Is Modifierfalse
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        6. RegulatedAuthorization.implicitRules
                        Definition

                        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.

                        ShortA set of rules under which this content was created
                        Comments

                        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.

                        Control0..1
                        Typeuri
                        Is Modifiertrue because This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summarytrue
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        8. RegulatedAuthorization.language
                        Definition

                        The base language in which the resource is written.

                        ShortLanguage of the resource content
                        Comments

                        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).

                        Control0..1
                        BindingThe codes SHALL be taken from AllLanguages
                        (required to http://hl7.org/fhir/ValueSet/all-languages|5.0.0)

                        IETF language tag for a human language

                        Typecode
                        Is Modifierfalse
                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                        Must Supportfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        10. RegulatedAuthorization.text
                        Definition

                        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.

                        ShortText summary of the resource, for human interpretation
                        Comments

                        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.

                        Control0..1
                        This element is affected by the following invariants: dom-6
                        TypeNarrative
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Alternate Namesnarrative, html, xhtml, display
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        12. RegulatedAuthorization.contained
                        Definition

                        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.

                        ShortContained, inline Resources
                        Comments

                        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.

                        Control0..*
                        This element is affected by the following invariants: dom-2, dom-4, dom-3, dom-5
                        TypeResource
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Alternate Namesinline resources, anonymous resources, contained resources
                        14. RegulatedAuthorization.extension
                        Definition

                        An Extension

                        ShortExtension
                        Control0..*
                        TypeExtension
                        Is Modifierfalse
                        Must Supportfalse
                        Summaryfalse
                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                        SlicingThis element introduces a set of slices on RegulatedAuthorization.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                        • value @ url
                        • 16. RegulatedAuthorization.extension:dateOfFirstAuthorisation
                          Slice NamedateOfFirstAuthorisation
                          Definition

                          The Regulated Authorization's Date of First Authorisation

                          ShortRegulated Authorization - Date of First Authorisation
                          Control0..1
                          TypeExtension(Regulated Authorization - Date of First Authorisation) (Extension Type: date)
                          Is Modifierfalse
                          Must Supportfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          18. RegulatedAuthorization.extension:internationalBirthDate
                          Slice NameinternationalBirthDate
                          Definition

                          The Regulated Authorization's International Birth Date

                          ShortRegulated Authorization - International Birth Date
                          Control0..1
                          TypeExtension(Regulated Authorization - International Birth Date) (Extension Type: date)
                          Is Modifierfalse
                          Must Supportfalse
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          20. RegulatedAuthorization.modifierExtension
                          Definition

                          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).

                          ShortExtensions that cannot be ignored
                          Comments

                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                          Control0..*
                          TypeExtension
                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
                          Must Supportfalse
                          Summarytrue
                          Requirements

                          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.

                          Alternate Namesextensions, user content
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                          22. RegulatedAuthorization.identifier
                          Definition

                          Business identifier for the authorization, typically assigned by the authorizing body.

                          ShortBusiness identifier for the authorization, typically assigned by the authorizing body
                          NoteThis is a business identifier, not a resource identifier (see discussion)
                          Control0..1
                          TypeIdentifier
                          Is Modifierfalse
                          Must Supportfalse
                          Summarytrue
                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                          SlicingThis element introduces a set of slices on RegulatedAuthorization.identifier. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                          • value @ system
                          • 24. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier
                            Slice NamemarketingAuthorizationIdentifier
                            Definition

                            Business identifier for the authorization, typically assigned by the authorizing body.

                            ShortBusiness identifier for the authorization, typically assigned by the authorizing body
                            NoteThis is a business identifier, not a resource identifier (see discussion)
                            Control0..1
                            TypeIdentifier(EMA Marketing Authorization Identifier)
                            Is Modifierfalse
                            Must Supportfalse
                            Summarytrue
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            26. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.id
                            Definition

                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                            ShortUnique id for inter-element referencing
                            Control0..1
                            This element is affected by the following invariants: ele-1
                            Typeid
                            Is Modifierfalse
                            XML FormatIn the XML format, this property is represented as an attribute.
                            Summaryfalse
                            28. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.extension
                            Definition

                            An Extension

                            ShortExtension
                            Control0..0
                            TypeExtension
                            Is Modifierfalse
                            Summaryfalse
                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                            SlicingThis element introduces a set of slices on RegulatedAuthorization.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                            • value @ url
                            • 30. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.use
                              Definition

                              The purpose of this identifier.

                              Shortusual | official | temp | secondary | old (If known)
                              Comments

                              Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                              Control0..0
                              BindingThe codes SHALL be taken from IdentifierUse
                              (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                              Identifies the purpose for this identifier, if known .

                              Typecode
                              Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              32. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.type
                              Definition

                              A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                              ShortDescription of identifier
                              Comments

                              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.

                              Control0..0
                              BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                              (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                              A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                              TypeCodeableConcept
                              Is Modifierfalse
                              Summarytrue
                              Requirements

                              Allows users to make use of identifiers when the identifier system is not known.

                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              34. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.system
                              Definition

                              Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                              ShortThe namespace for the identifier value
                              Comments

                              Identifier.system is always case sensitive.

                              Control1..1
                              Typeuri
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Requirements

                              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.

                              Pattern Valuehttp://ema.europa.eu/fhir/marketingAuthorizationNumber
                              Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              36. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.value
                              Definition

                              The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                              ShortThe value that is unique
                              Comments

                              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). 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.

                              Control1..1
                              This element is affected by the following invariants: ident-1
                              Typestring
                              Is Modifierfalse
                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                              Summarytrue
                              Example<br/><b>General</b>:123456
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              38. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.period
                              Definition

                              Time period during which identifier is/was valid for use.

                              ShortTime period when id is/was valid for use
                              Control0..0
                              TypePeriod
                              Is Modifierfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              40. RegulatedAuthorization.identifier:marketingAuthorizationIdentifier.assigner
                              Definition

                              Organization that issued/manages the identifier.

                              ShortOrganization that issued id (may be just text)
                              Comments

                              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.

                              Control0..0
                              TypeReference(Organization)
                              Is Modifierfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              42. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier
                              Slice NamemanufacturingAuthorizationNumberIdentifier
                              Definition

                              Business identifier for the authorization, typically assigned by the authorizing body.

                              ShortBusiness identifier for the authorization, typically assigned by the authorizing body
                              NoteThis is a business identifier, not a resource identifier (see discussion)
                              Control0..1
                              TypeIdentifier(EMA Manufacturing Authorization Number Identifier)
                              Is Modifierfalse
                              Must Supportfalse
                              Summarytrue
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              44. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.id
                              Definition

                              Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                              ShortUnique id for inter-element referencing
                              Control0..1
                              This element is affected by the following invariants: ele-1
                              Typeid
                              Is Modifierfalse
                              XML FormatIn the XML format, this property is represented as an attribute.
                              Summaryfalse
                              46. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.extension
                              Definition

                              An Extension

                              ShortExtension
                              Control0..0
                              TypeExtension
                              Is Modifierfalse
                              Summaryfalse
                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                              ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                              SlicingThis element introduces a set of slices on RegulatedAuthorization.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                              • value @ url
                              • 48. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.use
                                Definition

                                The purpose of this identifier.

                                Shortusual | official | temp | secondary | old (If known)
                                Comments

                                Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                Control0..0
                                BindingThe codes SHALL be taken from IdentifierUse
                                (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                Identifies the purpose for this identifier, if known .

                                Typecode
                                Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                50. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.type
                                Definition

                                A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                ShortDescription of identifier
                                Comments

                                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.

                                Control0..0
                                BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                                A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                TypeCodeableConcept
                                Is Modifierfalse
                                Summarytrue
                                Requirements

                                Allows users to make use of identifiers when the identifier system is not known.

                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                52. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.system
                                Definition

                                Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                ShortThe namespace for the identifier value
                                Comments

                                Identifier.system is always case sensitive.

                                Control1..1
                                Typeuri
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Requirements

                                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.

                                Pattern Valuehttp://ema.europa.eu/fhir/manufacturingAuthorizationNumber
                                Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                54. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.value
                                Definition

                                The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                ShortThe value that is unique
                                Comments

                                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). 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.

                                Control1..1
                                This element is affected by the following invariants: ident-1
                                Typestring
                                Is Modifierfalse
                                Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                Summarytrue
                                Example<br/><b>General</b>:123456
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                56. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.period
                                Definition

                                Time period during which identifier is/was valid for use.

                                ShortTime period when id is/was valid for use
                                Control0..0
                                TypePeriod
                                Is Modifierfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                58. RegulatedAuthorization.identifier:manufacturingAuthorizationNumberIdentifier.assigner
                                Definition

                                Organization that issued/manages the identifier.

                                ShortOrganization that issued id (may be just text)
                                Comments

                                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.

                                Control0..0
                                TypeReference(Organization)
                                Is Modifierfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                60. RegulatedAuthorization.subject
                                Definition

                                The product type, treatment, facility or activity that is being authorized.

                                ShortThe product type, treatment, facility or activity that is being authorized
                                Control1..1
                                TypeReference(EMA Write API MedicinalProductDefinition, EMA Write API PackagedProductDefinition, EMA Write API ActivityDefinition)
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                62. RegulatedAuthorization.type
                                Definition

                                Overall type of this authorization, for example drug marketing approval, orphan drug designation.

                                ShortOverall type of this authorization, for example drug marketing approval, orphan drug designation
                                Control1..1
                                BindingThe codes SHALL be taken from Regulatory Entitlement Type
                                (required to http://ema.europa.eu/fhir/vs/regulatoryEntitlementType)
                                TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                Is Modifierfalse
                                Must Supportfalse
                                Summarytrue
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                64. RegulatedAuthorization.type.id
                                Definition

                                Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                ShortUnique id for inter-element referencing
                                Control0..1
                                This element is affected by the following invariants: ele-1
                                Typeid
                                Is Modifierfalse
                                XML FormatIn the XML format, this property is represented as an attribute.
                                Summaryfalse
                                66. RegulatedAuthorization.type.extension
                                Definition

                                An Extension

                                ShortExtension
                                Control0..0
                                TypeExtension
                                Is Modifierfalse
                                Summaryfalse
                                Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                SlicingThis element introduces a set of slices on RegulatedAuthorization.type.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                • value @ url
                                • 68. RegulatedAuthorization.type.coding
                                  Definition

                                  A reference to a code defined by a terminology system.

                                  ShortCode defined by a terminology system
                                  Comments

                                  Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.

                                  Control1..1
                                  BindingThe codes SHALL be taken from Marketing and Manufacturing types
                                  (required to http://ema.europa.eu/fhir/vs/marketingAndManufacturingTypes)
                                  TypeCoding(EMA Coding)
                                  Is Modifierfalse
                                  Summarytrue
                                  Requirements

                                  Allows for alternative encodings within a code system, and translations to other code systems.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  70. RegulatedAuthorization.type.text
                                  Definition

                                  A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.

                                  ShortPlain text representation of the concept
                                  Comments

                                  Very often the text is the same as a displayName of one of the codings.

                                  Control0..0
                                  Typestring
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Summarytrue
                                  Requirements

                                  The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.

                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  72. RegulatedAuthorization.description
                                  Definition

                                  General textual supporting information.

                                  ShortGeneral textual supporting information
                                  Control0..1
                                  Typemarkdown
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  74. RegulatedAuthorization.region
                                  Definition

                                  The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.

                                  ShortThe territory in which the authorization has been granted
                                  Control0..*
                                  BindingFor example codes, see JurisdictionValueSet
                                  (example to http://hl7.org/fhir/ValueSet/jurisdiction)

                                  Jurisdiction codes

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  76. RegulatedAuthorization.status
                                  Definition

                                  The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.

                                  ShortThe status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
                                  Control1..1
                                  BindingThe codes SHALL be taken from Regulatory Entitlement Status
                                  (required to http://ema.europa.eu/fhir/vs/regulatoryEntitlementStatus)
                                  TypeCodeableConcept(EMA Generic ReferentialTerm CodeableConcept)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  78. RegulatedAuthorization.statusDate
                                  Definition

                                  The date at which the current status was assigned.

                                  ShortThe date at which the current status was assigned
                                  Control0..1
                                  TypedateTime
                                  Is Modifierfalse
                                  Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  80. RegulatedAuthorization.validityPeriod
                                  Definition

                                  The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.

                                  ShortThe time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
                                  Control0..1
                                  TypePeriod
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  82. RegulatedAuthorization.indication
                                  Definition

                                  Condition for which the use of the regulated product applies.

                                  ShortCondition for which the use of the regulated product applies
                                  Control0..*
                                  TypeCodeableReference(ClinicalUseDefinition)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  84. RegulatedAuthorization.intendedUse
                                  Definition

                                  The intended use of the product, e.g. prevention, treatment, diagnosis.

                                  ShortThe intended use of the product, e.g. prevention, treatment
                                  Control0..1
                                  BindingThe codes SHOULD be taken from ProductIntendedUse
                                  (preferred to http://hl7.org/fhir/ValueSet/product-intended-use)

                                  The overall intended use of a product.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  86. RegulatedAuthorization.basis
                                  Definition

                                  The legal or regulatory framework against which this authorization is granted, or other reasons for it.

                                  ShortThe legal/regulatory framework or reasons under which this authorization is granted
                                  Control0..*
                                  BindingFor example codes, see RegulatedAuthorizationBasis
                                  (example to http://hl7.org/fhir/ValueSet/regulated-authorization-basis)

                                  A legal or regulatory framework against which an authorization is granted, or other reasons for it.

                                  TypeCodeableConcept
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  88. RegulatedAuthorization.holder
                                  Definition

                                  The organization that has been granted this authorization, by some authoritative body (the 'regulator').

                                  ShortThe organization that has been granted this authorization, by the regulator
                                  Control1..1
                                  TypeReference(Organization)
                                  Is Modifierfalse
                                  Must Supportfalse
                                  Summarytrue
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  90. RegulatedAuthorization.holder.id
                                  Definition

                                  Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                  ShortUnique id for inter-element referencing
                                  Control0..1
                                  This element is affected by the following invariants: ele-1
                                  Typeid
                                  Is Modifierfalse
                                  XML FormatIn the XML format, this property is represented as an attribute.
                                  Summaryfalse
                                  92. RegulatedAuthorization.holder.extension
                                  Definition

                                  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.

                                  ShortAdditional content defined by implementations
                                  Comments

                                  There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                  Control0..*
                                  TypeExtension
                                  Is Modifierfalse
                                  Summaryfalse
                                  Alternate Namesextensions, user content
                                  Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                  ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                  SlicingThis element introduces a set of slices on RegulatedAuthorization.holder.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                  • value @ url
                                  • 94. RegulatedAuthorization.holder.reference
                                    Definition

                                    A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                                    ShortLiteral reference, Relative, internal or absolute URL
                                    Comments

                                    Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                                    Control0..1
                                    This element is affected by the following invariants: ref-2, ref-1
                                    Typestring
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    96. RegulatedAuthorization.holder.type
                                    Definition

                                    The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                                    The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                                    ShortType the reference refers to (e.g. "Patient") - must be a resource in resources
                                    Comments

                                    This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.

                                    Control0..1
                                    BindingUnless not suitable, these codes SHALL be taken from ResourceType
                                    (extensible to http://hl7.org/fhir/ValueSet/resource-types)

                                    Aa resource (or, for logical models, the URI of the logical model).

                                    Typeuri
                                    Is Modifierfalse
                                    Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    98. RegulatedAuthorization.holder.identifier
                                    Definition

                                    An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                                    ShortLogical reference, when literal reference is not known
                                    Comments

                                    When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                                    When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                                    Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                                    Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                                    This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.

                                    NoteThis is a business identifier, not a resource identifier (see discussion)
                                    Control1..1
                                    This element is affected by the following invariants: ref-2
                                    TypeIdentifier
                                    Is Modifierfalse
                                    Summarytrue
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    100. RegulatedAuthorization.holder.identifier.id
                                    Definition

                                    Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                    ShortUnique id for inter-element referencing
                                    Control0..1
                                    This element is affected by the following invariants: ele-1
                                    Typeid
                                    Is Modifierfalse
                                    XML FormatIn the XML format, this property is represented as an attribute.
                                    Summaryfalse
                                    102. RegulatedAuthorization.holder.identifier.extension
                                    Definition

                                    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.

                                    ShortAdditional content defined by implementations
                                    Comments

                                    There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                    Control0..*
                                    TypeExtension
                                    Is Modifierfalse
                                    Summaryfalse
                                    Alternate Namesextensions, user content
                                    Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                    ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                    SlicingThis element introduces a set of slices on RegulatedAuthorization.holder.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                    • value @ url
                                    • 104. RegulatedAuthorization.holder.identifier.use
                                      Definition

                                      The purpose of this identifier.

                                      Shortusual | official | temp | secondary | old (If known)
                                      Comments

                                      Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                      Control0..1
                                      BindingThe codes SHALL be taken from IdentifierUse
                                      (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                      Identifies the purpose for this identifier, if known .

                                      Typecode
                                      Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      106. RegulatedAuthorization.holder.identifier.type
                                      Definition

                                      A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                      ShortDescription of identifier
                                      Comments

                                      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.

                                      Control0..1
                                      BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                      (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                                      A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                      TypeCodeableConcept
                                      Is Modifierfalse
                                      Summarytrue
                                      Requirements

                                      Allows users to make use of identifiers when the identifier system is not known.

                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      108. RegulatedAuthorization.holder.identifier.system
                                      Definition

                                      Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                      ShortThe namespace for the identifier value
                                      Comments

                                      Identifier.system is always case sensitive.

                                      Control1..1
                                      Typeuri
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Requirements

                                      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.

                                      Pattern Valuehttps://spor.ema.europa.eu/v1/locations
                                      Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      110. RegulatedAuthorization.holder.identifier.value
                                      Definition

                                      The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                      ShortThe value that is unique
                                      Comments

                                      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). 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.

                                      Control1..1
                                      This element is affected by the following invariants: ident-1
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Example<br/><b>General</b>:123456
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      112. RegulatedAuthorization.holder.identifier.period
                                      Definition

                                      Time period during which identifier is/was valid for use.

                                      ShortTime period when id is/was valid for use
                                      Control0..1
                                      TypePeriod
                                      Is Modifierfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      114. RegulatedAuthorization.holder.identifier.assigner
                                      Definition

                                      Organization that issued/manages the identifier.

                                      ShortOrganization that issued id (may be just text)
                                      Comments

                                      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.

                                      Control0..1
                                      TypeReference(Organization)
                                      Is Modifierfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      116. RegulatedAuthorization.holder.display
                                      Definition

                                      Plain text narrative that identifies the resource in addition to the resource reference.

                                      ShortText alternative for the resource
                                      Comments

                                      This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                                      Control0..1
                                      This element is affected by the following invariants: ref-2
                                      Typestring
                                      Is Modifierfalse
                                      Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      118. RegulatedAuthorization.regulator
                                      Definition

                                      The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.

                                      ShortThe regulatory authority or authorizing body granting the authorization
                                      Control0..1
                                      TypeReference(Organization)
                                      Is Modifierfalse
                                      Must Supportfalse
                                      Summarytrue
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      120. RegulatedAuthorization.regulator.id
                                      Definition

                                      Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                      ShortUnique id for inter-element referencing
                                      Control0..1
                                      This element is affected by the following invariants: ele-1
                                      Typeid
                                      Is Modifierfalse
                                      XML FormatIn the XML format, this property is represented as an attribute.
                                      Summaryfalse
                                      122. RegulatedAuthorization.regulator.extension
                                      Definition

                                      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.

                                      ShortAdditional content defined by implementations
                                      Comments

                                      There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                      Control0..*
                                      TypeExtension
                                      Is Modifierfalse
                                      Summaryfalse
                                      Alternate Namesextensions, user content
                                      Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                      ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                      SlicingThis element introduces a set of slices on RegulatedAuthorization.regulator.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                      • value @ url
                                      • 124. RegulatedAuthorization.regulator.reference
                                        Definition

                                        A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.

                                        ShortLiteral reference, Relative, internal or absolute URL
                                        Comments

                                        Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.

                                        Control0..1
                                        This element is affected by the following invariants: ref-2, ref-1
                                        Typestring
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        126. RegulatedAuthorization.regulator.type
                                        Definition

                                        The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent.

                                        The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).

                                        ShortType the reference refers to (e.g. "Patient") - must be a resource in resources
                                        Comments

                                        This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.

                                        Control0..1
                                        BindingUnless not suitable, these codes SHALL be taken from ResourceType
                                        (extensible to http://hl7.org/fhir/ValueSet/resource-types)

                                        Aa resource (or, for logical models, the URI of the logical model).

                                        Typeuri
                                        Is Modifierfalse
                                        Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        128. RegulatedAuthorization.regulator.identifier
                                        Definition

                                        An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.

                                        ShortLogical reference, when literal reference is not known
                                        Comments

                                        When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy.

                                        When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference

                                        Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it.

                                        Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any).

                                        This element only allows for a single identifier. In the case where additional identifers are required, use the http://hl7.org/fhir/StructureDefinition/additionalIdentifier extension.

                                        NoteThis is a business identifier, not a resource identifier (see discussion)
                                        Control0..1
                                        This element is affected by the following invariants: ref-2
                                        TypeIdentifier
                                        Is Modifierfalse
                                        Summarytrue
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        130. RegulatedAuthorization.regulator.identifier.id
                                        Definition

                                        Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                        ShortUnique id for inter-element referencing
                                        Control0..1
                                        This element is affected by the following invariants: ele-1
                                        Typeid
                                        Is Modifierfalse
                                        XML FormatIn the XML format, this property is represented as an attribute.
                                        Summaryfalse
                                        132. RegulatedAuthorization.regulator.identifier.extension
                                        Definition

                                        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.

                                        ShortAdditional content defined by implementations
                                        Comments

                                        There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                        Control0..*
                                        TypeExtension
                                        Is Modifierfalse
                                        Summaryfalse
                                        Alternate Namesextensions, user content
                                        Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                        ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                        SlicingThis element introduces a set of slices on RegulatedAuthorization.regulator.identifier.extension. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                        • value @ url
                                        • 134. RegulatedAuthorization.regulator.identifier.use
                                          Definition

                                          The purpose of this identifier.

                                          Shortusual | official | temp | secondary | old (If known)
                                          Comments

                                          Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.

                                          Control0..1
                                          BindingThe codes SHALL be taken from IdentifierUse
                                          (required to http://hl7.org/fhir/ValueSet/identifier-use|5.0.0)

                                          Identifies the purpose for this identifier, if known .

                                          Typecode
                                          Is Modifiertrue because This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          136. RegulatedAuthorization.regulator.identifier.type
                                          Definition

                                          A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.

                                          ShortDescription of identifier
                                          Comments

                                          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.

                                          Control0..1
                                          BindingUnless not suitable, these codes SHALL be taken from IdentifierTypeCodes
                                          (extensible to http://hl7.org/fhir/ValueSet/identifier-type)

                                          A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Summarytrue
                                          Requirements

                                          Allows users to make use of identifiers when the identifier system is not known.

                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          138. RegulatedAuthorization.regulator.identifier.system
                                          Definition

                                          Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.

                                          ShortThe namespace for the identifier value
                                          Comments

                                          Identifier.system is always case sensitive.

                                          Control1..1
                                          Typeuri
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Requirements

                                          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.

                                          Pattern Valuehttps://spor.ema.europa.eu/v1/locations
                                          Example<br/><b>General</b>:http://www.acme.com/identifiers/patient
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          140. RegulatedAuthorization.regulator.identifier.value
                                          Definition

                                          The portion of the identifier typically relevant to the user and which is unique within the context of the system.

                                          ShortThe value that is unique
                                          Comments

                                          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). 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.

                                          Control1..1
                                          This element is affected by the following invariants: ident-1
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Example<br/><b>General</b>:123456
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          142. RegulatedAuthorization.regulator.identifier.period
                                          Definition

                                          Time period during which identifier is/was valid for use.

                                          ShortTime period when id is/was valid for use
                                          Control0..1
                                          TypePeriod
                                          Is Modifierfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          144. RegulatedAuthorization.regulator.identifier.assigner
                                          Definition

                                          Organization that issued/manages the identifier.

                                          ShortOrganization that issued id (may be just text)
                                          Comments

                                          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.

                                          Control0..1
                                          TypeReference(Organization)
                                          Is Modifierfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          146. RegulatedAuthorization.regulator.display
                                          Definition

                                          Plain text narrative that identifies the resource in addition to the resource reference.

                                          ShortText alternative for the resource
                                          Comments

                                          This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.

                                          Control0..1
                                          This element is affected by the following invariants: ref-2
                                          Typestring
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          148. RegulatedAuthorization.attachedDocument
                                          Definition

                                          Additional information or supporting documentation about the authorization.

                                          ShortAdditional information or supporting documentation about the authorization
                                          Control0..*
                                          TypeReference(DocumentReference)
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          150. RegulatedAuthorization.case
                                          Definition

                                          The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).

                                          ShortThe case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
                                          Control1..1
                                          TypeBackboneElement
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          152. RegulatedAuthorization.case.id
                                          Definition

                                          Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                          ShortUnique id for inter-element referencing
                                          Control0..1
                                          This element is affected by the following invariants: ele-1
                                          Typestring
                                          Is Modifierfalse
                                          XML FormatIn the XML format, this property is represented as an attribute.
                                          Summaryfalse
                                          154. RegulatedAuthorization.case.extension
                                          Definition

                                          The Paediatric Regulated Authorization's Reference Country

                                          ShortRegulated Authorization - Paediatric - Reference Country
                                          Control1..1
                                          TypeExtension(Regulated Authorization - Paediatric - Reference Country) (Extension Type: Coding(EMA Coding))
                                          Is Modifierfalse
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          156. RegulatedAuthorization.case.modifierExtension
                                          Definition

                                          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).

                                          ShortExtensions that cannot be ignored even if unrecognized
                                          Comments

                                          There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                          Control0..*
                                          TypeExtension
                                          Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                          Summarytrue
                                          Requirements

                                          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.

                                          Alternate Namesextensions, user content, modifiers
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                          158. RegulatedAuthorization.case.identifier
                                          Definition

                                          Identifier by which this case can be referenced.

                                          ShortIdentifier by which this case can be referenced
                                          NoteThis is a business identifier, not a resource identifier (see discussion)
                                          Control0..1
                                          TypeIdentifier
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          160. RegulatedAuthorization.case.type
                                          Definition

                                          The defining type of case.

                                          ShortThe defining type of case
                                          Control0..1
                                          BindingFor example codes, see RegulatedAuthorizationCaseType
                                          (example to http://hl7.org/fhir/ValueSet/regulated-authorization-case-type)

                                          The type of a case involved in an application.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          162. RegulatedAuthorization.case.status
                                          Definition

                                          The status associated with the case.

                                          ShortThe status associated with the case
                                          Control0..1
                                          BindingThe codes SHOULD be taken from PublicationStatus
                                          (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                          The lifecycle status of an artifact.

                                          TypeCodeableConcept
                                          Is Modifierfalse
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          164. RegulatedAuthorization.case.date[x]
                                          Definition

                                          Relevant date for this case.

                                          ShortRelevant date for this case
                                          Control0..1
                                          TypeChoice of: Period, dateTime
                                          [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                          Is Modifierfalse
                                          Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                          Must Supportfalse
                                          Summarytrue
                                          Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                          SlicingThis element introduces a set of slices on RegulatedAuthorization.case.date[x]. The slices areUnordered and Open, and can be differentiated using the following discriminators:
                                          • type @ $this
                                          • 166. RegulatedAuthorization.case.date[x]:datePeriod
                                            Slice NamedatePeriod
                                            Definition

                                            Relevant date for this case.

                                            ShortRelevant date for this case
                                            Control0..1
                                            TypePeriod
                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            168. RegulatedAuthorization.case.application
                                            Definition

                                            A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.

                                            ShortApplications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
                                            Control0..1
                                            TypeBackboneElement
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            170. RegulatedAuthorization.case.application.id
                                            Definition

                                            Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

                                            ShortUnique id for inter-element referencing
                                            Control0..1
                                            This element is affected by the following invariants: ele-1
                                            Typestring
                                            Is Modifierfalse
                                            XML FormatIn the XML format, this property is represented as an attribute.
                                            Summaryfalse
                                            172. RegulatedAuthorization.case.application.extension
                                            Definition

                                            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.

                                            ShortAdditional content defined by implementations
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifierfalse
                                            Summaryfalse
                                            Alternate Namesextensions, user content
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            174. RegulatedAuthorization.case.application.modifierExtension
                                            Definition

                                            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).

                                            ShortExtensions that cannot be ignored even if unrecognized
                                            Comments

                                            There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

                                            Control0..*
                                            TypeExtension
                                            Is Modifiertrue because Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
                                            Summarytrue
                                            Requirements

                                            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.

                                            Alternate Namesextensions, user content, modifiers
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            ext-1: Must have either extensions or value[x], not both (extension.exists() != value.exists())
                                            176. RegulatedAuthorization.case.application.identifier
                                            Definition

                                            Identifier by which this case can be referenced.

                                            ShortIdentifier by which this case can be referenced
                                            NoteThis is a business identifier, not a resource identifier (see discussion)
                                            Control0..1
                                            TypeIdentifier(EMA Application Identifier Number)
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            178. RegulatedAuthorization.case.application.type
                                            Definition

                                            The defining type of case.

                                            ShortThe defining type of case
                                            Control0..1
                                            BindingThe codes SHALL be taken from Application Submission Type
                                            (required to http://ema.europa.eu/fhir/vs/applicationSubmissionType)
                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            180. RegulatedAuthorization.case.application.status
                                            Definition

                                            The status associated with the case.

                                            ShortThe status associated with the case
                                            Control0..1
                                            BindingThe codes SHOULD be taken from PublicationStatus
                                            (preferred to http://hl7.org/fhir/ValueSet/publication-status)

                                            The lifecycle status of an artifact.

                                            TypeCodeableConcept
                                            Is Modifierfalse
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            182. RegulatedAuthorization.case.application.date[x]
                                            Definition

                                            Relevant date for this case.

                                            ShortRelevant date for this case
                                            Control1..1
                                            TypedateTime
                                            [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                            Is Modifierfalse
                                            Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                            Must Supportfalse
                                            Summarytrue
                                            Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                            SlicingThis element introduces a set of slices on RegulatedAuthorization.case.application.date[x]. The slices areUnordered and Closed, and can be differentiated using the following discriminators:
                                            • type @ $this
                                            • 184. RegulatedAuthorization.case.application.date[x]:dateDateTime
                                              Slice NamedateDateTime
                                              Definition

                                              Relevant date for this case.

                                              ShortRelevant date for this case
                                              Control1..1
                                              TypedateTime
                                              [x] NoteSeeChoice of Data Typesfor further information about how to use [x]
                                              Is Modifierfalse
                                              Primitive ValueThis primitive element may be present, or absent, or replaced by an extension
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))
                                              186. RegulatedAuthorization.case.application.application
                                              Definition

                                              A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.

                                              ShortApplications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
                                              Control0..*
                                              TypeSeettp://hl7.org/fhir/StructureDefinition/RegulatedAuthorization#RegulatedAuthorization.case
                                              Is Modifierfalse
                                              Must Supportfalse
                                              Summarytrue
                                              Invariantsele-1: All FHIR elements must have a @value or children (hasValue() or (children().count() > id.count()))