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: EMA Write API MedicinalProductDefinition

Official URL: http://ema.europa.eu/fhir/StructureDefinition/emaWriteApiMedicinalProductDefinition Version: 1.0.0
Draft as of 2025-04-04 Computable Name: EmaWriteApiMedicinalProductDefinition

Profiled resource containing data about a Medicinal Product.

Usage:

Formal Views of Profile Content

Description of Profiles, Differentials, Snapshots and how the different presentations work.

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... contained 0..* Resource Contained, inline Resources
... extension 1..* EmaCoding Authorised Dose Form
URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm
Binding: Authorised Dose Form (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... Slices for identifier Σ 0..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
ele-1: All FHIR elements must have a @value or children
.... identifier:All Slices Content/Rules for all slices
..... extension 0..0
.... identifier:eurdId Σ 0..1 EmaEurdIdentifier Business identifier for this product. Could be an MPID
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/eurdId
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:mpId Σ 0..1 EmaMpIdentifier Business identifier for this product. Could be an MPID
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/mpId
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
... type Σ 1..1 EmaRefTermCodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: Medicinal Product Type (required)
ele-1: All FHIR elements must have a @value or children
... domain Σ 1..1 EmaRefTermCodeableConcept If this medicine applies to human or veterinary uses
Binding: Domain (required)
ele-1: All FHIR elements must have a @value or children
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.


ele-1: All FHIR elements must have a @value or children
... combinedPharmaceuticalDoseForm Σ 1..1 EmaRefTermCodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Combined Pharmaceutical Dose Form (required)
ele-1: All FHIR elements must have a @value or children
... indication Σ 1..1 markdown Description of indication(s) for this product, used when structured indications are not required
ele-1: All FHIR elements must have a @value or children
.... extension 1..1 EmaCoding Language
URL: http://ema.europa.eu/fhir/extension/language
Binding: Language (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... legalStatusOfSupply Σ 1..1 EmaRefTermCodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: Legal Status of Supply (required)
ele-1: All FHIR elements must have a @value or children
... additionalMonitoringIndicator Σ 1..1 EmaRefTermCodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: Additional Monitoring Indicator (required)
ele-1: All FHIR elements must have a @value or children
... pediatricUseIndicator Σ 1..1 EmaRefTermCodeableConcept If authorised for use in children
Binding: Paediatric Use Indicator (required)
ele-1: All FHIR elements must have a @value or children
... Slices for classification Σ 4..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Closed by value:coding.system
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
.... classification:xevmpd Σ 1..1 EmaXevmpdProductCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
..... extension 0..0
.... classification:legalBasis Σ 1..1 EmaLegalBasisCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
..... extension 0..0
.... classification:lightAtc Σ 1..* EmaLightAtcCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
..... extension 0..0 (Complex)
...... extension:All Slices Content/Rules for all slices
..... coding Σ 1..1 EmaAtcCoding Code defined by a terminology system
ele-1: All FHIR elements must have a @value or children
...... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
...... code ΣC 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
.... classification:productCategory Σ 1..* EmaProductCategoryCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
..... extension 0..0
... masterFile Σ 1..1 Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
ele-1: All FHIR elements must have a @value or children
... contact Σ 0..1 BackboneElement A product specific contact, person (in a role), or an organization
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type Σ 0..1 EmaQualifiedPersonTypeCodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.


ele-1: All FHIR elements must have a @value or children
.... contact Σ 1..1 Reference(PractitionerRole) A product specific contact, person (in a role), or an organization
ele-1: All FHIR elements must have a @value or children
... name Σ 1..1 BackboneElement The product's name, including full name and possibly coded parts
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... productName Σ 1..1 string The full product name
ele-1: All FHIR elements must have a @value or children
.... type Σ 0..1 EmaRefTermCodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Medicinal Product Name Part Type (required)
ele-1: All FHIR elements must have a @value or children
.... Slices for part Σ 1..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
ele-1: All FHIR elements must have a @value or children
..... part:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... part Σ 1..1 string A fragment of a product name
ele-1: All FHIR elements must have a @value or children
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
ele-1: All FHIR elements must have a @value or children
..... part:inventedName Σ 0..1 BackboneElement Coding words or phrases of the name
ele-1: All FHIR elements must have a @value or children
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... part Σ 1..1 string A fragment of a product name
ele-1: All FHIR elements must have a @value or children
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
..... part:fullName Σ 0..1 BackboneElement Coding words or phrases of the name
ele-1: All FHIR elements must have a @value or children
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... part Σ 1..1 string A fragment of a product name
ele-1: All FHIR elements must have a @value or children
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000001
..... part:pharmaceuticalDoseForm Σ 0..1 BackboneElement Coding words or phrases of the name
ele-1: All FHIR elements must have a @value or children
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... part Σ 1..1 string A fragment of a product name
ele-1: All FHIR elements must have a @value or children
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000005
.... usage Σ 1..1 BackboneElement Country and jurisdiction where the name applies
ele-1: All FHIR elements must have a @value or children
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... country Σ 1..1 EmaRefTermCodeableConcept Country code for where this name applies
Binding: Country (required)
ele-1: All FHIR elements must have a @value or children
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: Language (required)
Additional BindingsPurpose
CommonLanguages Starter

ele-1: All FHIR elements must have a @value or children
... crossReference Σ 1..1 BackboneElement Reference to another product, e.g. for linking authorised to investigational product
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
ele-1: All FHIR elements must have a @value or children
.... type Σ 1..1 EmaRefTermCodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: Product Cross Reference Type (required)
ele-1: All FHIR elements must have a @value or children
... characteristic Σ 1..1 BackboneElement Key product features such as "sugar free", "modified release"
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type Σ 1..1 EmaGmoCodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.typerequiredMedicinalProductTypeVs (a valid code from Medicinal Product Type)
http://ema.europa.eu/fhir/vs/medicinalProductType
from this IG
MedicinalProductDefinition.domainrequiredDomainVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredCombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)
http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm
from this IG
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.additionalMonitoringIndicatorrequiredAdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator
from this IG
MedicinalProductDefinition.pediatricUseIndicatorrequiredPaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/paediatricUseIndicator
from this IG
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:xevmpdexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:legalBasisexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:lightAtcexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:productCategoryexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.name.typerequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part:inventedName.typeexamplePattern: 220000000002
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:fullName.typeexamplePattern: 220000000001
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.typeexamplePattern: 220000000005
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
MedicinalProductDefinition.name.usage.languagerequiredLanguageVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/language
from this IG
MedicinalProductDefinition.crossReference.typerequiredProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)
http://ema.europa.eu/fhir/vs/productcrossreferencetype
from this IG
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... extension 1..* EmaCoding Authorised Dose Form
URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm
Binding: Authorised Dose Form (required)
... Slices for identifier 0..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
.... identifier:All Slices Content/Rules for all slices
..... extension 0..0
..... use 0..0
..... type 0..0
..... period 0..0
..... assigner 0..0
.... identifier:eurdId 0..1 EmaEurdIdentifier Business identifier for this product. Could be an MPID
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/eurdId
.... identifier:mpId 0..1 EmaMpIdentifier Business identifier for this product. Could be an MPID
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/mpId
... type 1..1 EmaRefTermCodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: Medicinal Product Type (required)
... combinedPharmaceuticalDoseForm 1..1 EmaRefTermCodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Combined Pharmaceutical Dose Form (required)
... indication 1..1 markdown Description of indication(s) for this product, used when structured indications are not required
.... extension 1..1 EmaCoding Language
URL: http://ema.europa.eu/fhir/extension/language
Binding: Language (required)
... legalStatusOfSupply 1..1 EmaRefTermCodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: Legal Status of Supply (required)
... additionalMonitoringIndicator 1..1 EmaRefTermCodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: Additional Monitoring Indicator (required)
... pediatricUseIndicator 1..1 EmaRefTermCodeableConcept If authorised for use in children
Binding: Paediatric Use Indicator (required)
... Slices for classification 4..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Closed by value:coding.system
.... classification:xevmpd 1..1 EmaXevmpdProductCodeableConcept Allows the product to be classified by various systems
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324
.... classification:legalBasis 1..1 EmaLegalBasisCodeableConcept Allows the product to be classified by various systems
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045
.... classification:lightAtc 1..* EmaLightAtcCodeableConcept Allows the product to be classified by various systems
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
.... classification:productCategory 1..* EmaProductCategoryCodeableConcept Allows the product to be classified by various systems
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526
... masterFile 1..1 Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact 0..1 BackboneElement A product specific contact, person (in a role), or an organization
.... type 0..1 EmaQualifiedPersonTypeCodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
.... contact 1..1 Reference(PractitionerRole) A product specific contact, person (in a role), or an organization
... name 1..1 BackboneElement The product's name, including full name and possibly coded parts
.... type 0..1 EmaRefTermCodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Medicinal Product Name Part Type (required)
.... Slices for part 1..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... type
....... coding 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
..... part:inventedName 0..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
..... part:fullName 0..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000001
..... part:pharmaceuticalDoseForm 0..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000005
.... usage 1..1 BackboneElement Country and jurisdiction where the name applies
..... country 1..1 EmaRefTermCodeableConcept Country code for where this name applies
Binding: Country (required)
..... language 1..1 CodeableConcept Language code for this name
Binding: Language (required)
... crossReference 1..1 BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... product
..... reference
...... identifier 1..1 Identifier Logical reference, when literal reference is not known
....... system 0..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/crossReference
.... type 1..1 EmaRefTermCodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: Product Cross Reference Type (required)
... operation
.... type 0..1 CodeableReference(EMA Write API ActivityDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... confidentialityIndicator 0..1 EmaRefTermCodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: Data Classification (required)
... characteristic 1..1 BackboneElement Key product features such as "sugar free", "modified release"
.... type 1..1 EmaGmoCodeableConcept A code expressing the type of characteristic

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.typerequiredMedicinalProductTypeVs (a valid code from Medicinal Product Type)
http://ema.europa.eu/fhir/vs/medicinalProductType
from this IG
MedicinalProductDefinition.domainrequiredDomainVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredCombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)
http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm
from this IG
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.additionalMonitoringIndicatorrequiredAdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator
from this IG
MedicinalProductDefinition.pediatricUseIndicatorrequiredPaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/paediatricUseIndicator
from this IG
MedicinalProductDefinition.name.typerequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.usage.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
MedicinalProductDefinition.name.usage.languagerequiredLanguageVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/language
from this IG
MedicinalProductDefinition.crossReference.typerequiredProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)
http://ema.europa.eu/fhir/vs/productcrossreferencetype
from this IG
MedicinalProductDefinition.operation.confidentialityIndicatorrequiredDataClassificationVs (a valid code from Data Classification)
http://ema.europa.eu/fhir/vs/dataClassification
from this IG
NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 1..* EmaCoding Authorised Dose Form
URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm
Binding: Authorised Dose Form (required)
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier Σ 0..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
.... identifier:All Slices Content/Rules for all slices
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 0..1 string The value that is unique
Example General: 123456
.... identifier:eurdId Σ 0..1 EmaEurdIdentifier Business identifier for this product. Could be an MPID
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/eurdId
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:mpId Σ 0..1 EmaMpIdentifier Business identifier for this product. Could be an MPID
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/mpId
..... value ΣC 1..1 string The value that is unique
Example General: 123456
... type Σ 1..1 EmaRefTermCodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: Medicinal Product Type (required)
... domain Σ 1..1 EmaRefTermCodeableConcept If this medicine applies to human or veterinary uses
Binding: Domain (required)
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm Σ 1..1 EmaRefTermCodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Combined Pharmaceutical Dose Form (required)
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.


... indication Σ 1..1 markdown Description of indication(s) for this product, used when structured indications are not required
.... id 0..1 string xml:id (or equivalent in JSON)
.... extension 1..1 EmaCoding Language
URL: http://ema.europa.eu/fhir/extension/language
Binding: Language (required)
.... value 0..1 markdown Primitive value for markdown
... legalStatusOfSupply Σ 1..1 EmaRefTermCodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: Legal Status of Supply (required)
... additionalMonitoringIndicator Σ 1..1 EmaRefTermCodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: Additional Monitoring Indicator (required)
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 1..1 EmaRefTermCodeableConcept If authorised for use in children
Binding: Paediatric Use Indicator (required)
... Slices for classification Σ 4..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Closed by value:coding.system
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


.... classification:xevmpd Σ 1..1 EmaXevmpdProductCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: XEVMPD medicinal product type (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... classification:legalBasis Σ 1..1 EmaLegalBasisCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: XEVMPD medicinal product type (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... classification:lightAtc Σ 1..* EmaLightAtcCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 (Complex)
...... extension:All Slices Content/Rules for all slices
..... coding Σ 1..1 EmaAtcCoding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
....... id 0..1 string xml:id (or equivalent in JSON)
....... extension 0..* string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
....... value 0..1 uri Primitive value for uri
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
.... classification:productCategory Σ 1..* EmaProductCategoryCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: Product Category (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... attachedDocument Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 1..1 Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..1 BackboneElement A product specific contact, person (in a role), or an organization
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 EmaQualifiedPersonTypeCodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

.... contact Σ 1..1 Reference(PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.


... name Σ 1..1 BackboneElement The product's name, including full name and possibly coded parts
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name
.... type Σ 0..1 EmaRefTermCodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Medicinal Product Name Part Type (required)
.... Slices for part Σ 1..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
....... text Σ 0..1 string Plain text representation of the concept
..... part:inventedName Σ 0..1 BackboneElement Coding words or phrases of the name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
....... text Σ 0..1 string Plain text representation of the concept
..... part:fullName Σ 0..1 BackboneElement Coding words or phrases of the name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000001
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
....... text Σ 0..1 string Plain text representation of the concept
..... part:pharmaceuticalDoseForm Σ 0..1 BackboneElement Coding words or phrases of the name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000005
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
....... text Σ 0..1 string Plain text representation of the concept
.... usage Σ 1..1 BackboneElement Country and jurisdiction where the name applies
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 EmaRefTermCodeableConcept Country code for where this name applies
Binding: Country (required)
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... language Σ 1..1 CodeableConcept Language code for this name
Binding: Language (required)
Additional BindingsPurpose
CommonLanguages Starter
... crossReference Σ 1..1 BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ 0..1 CodeableConcept Reference to a concept (by class)
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
...... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

...... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

....... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

....... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/crossReference
....... value ΣC 0..1 string The value that is unique
Example General: 123456
....... period Σ 0..1 Period Time period when id is/was valid for use
....... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
...... display ΣC 0..1 string Text alternative for the resource
.... type Σ 1..1 EmaRefTermCodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: Product Cross Reference Type (required)
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(EMA Write API ActivityDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 EmaRefTermCodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: Data Classification (required)
... characteristic Σ 1..1 BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 EmaGmoCodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.typerequiredMedicinalProductTypeVs (a valid code from Medicinal Product Type)
http://ema.europa.eu/fhir/vs/medicinalProductType
from this IG
MedicinalProductDefinition.domainrequiredDomainVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredCombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)
http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm
from this IG
MedicinalProductDefinition.routeexampleSNOMEDCTRouteCodes
http://hl7.org/fhir/ValueSet/route-codes
from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.additionalMonitoringIndicatorrequiredAdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator
from this IG
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorrequiredPaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/paediatricUseIndicator
from this IG
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:xevmpdexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:xevmpd.codingrequiredXevmpdMedicinalProductTypeVs (a valid code from XEVMPD Medicinal Product Type)
http://ema.europa.eu/fhir/vs/xevmpdMedicinalProductType
from this IG
MedicinalProductDefinition.classification:legalBasisexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:legalBasis.codingrequiredMarketingAuthorisationApplicationLegalBasisVs (a valid code from Marketing Authorisation Application Legal Basis)
http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasis
from this IG
MedicinalProductDefinition.classification:lightAtcexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:productCategoryexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:productCategory.codingrequiredProductCategoryVs (a valid code from Product Category)
http://ema.europa.eu/fhir/vs/productCategory
from this IG
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typerequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part:inventedName.typeexamplePattern: 220000000002
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:inventedName.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part:fullName.typeexamplePattern: 220000000001
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:fullName.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.typeexamplePattern: 220000000005
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.usage.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
MedicinalProductDefinition.name.usage.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredLanguageVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/language
from this IG
MedicinalProductDefinition.crossReference.product.reference.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
MedicinalProductDefinition.crossReference.product.reference.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.product.reference.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
MedicinalProductDefinition.crossReference.typerequiredProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)
http://ema.europa.eu/fhir/vs/productcrossreferencetype
from this IG
MedicinalProductDefinition.operation.confidentialityIndicatorrequiredDataClassificationVs (a valid code from Data Classification)
http://ema.europa.eu/fhir/vs/dataClassification
from this IG
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 20 elements(6 nested mandatory elements)
Prohibited: 5 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.identifier (Closed)
  • The element 1 is sliced based on the value of MedicinalProductDefinition.classification (Closed)
  • The element 1 is sliced based on the value of MedicinalProductDefinition.name.part

Key Elements View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
dom-2: If the resource is contained in another resource, it SHALL NOT contain nested Resources
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
dom-4: If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
dom-5: If a resource is contained in another resource, it SHALL NOT have a security label
dom-6: A resource should have narrative for robust management
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
ele-1: All FHIR elements must have a @value or children
... contained 0..* Resource Contained, inline Resources
... extension 1..* EmaCoding Authorised Dose Form
URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm
Binding: Authorised Dose Form (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... Slices for identifier Σ 0..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
ele-1: All FHIR elements must have a @value or children
.... identifier:All Slices Content/Rules for all slices
..... extension 0..0
.... identifier:eurdId Σ 0..1 EmaEurdIdentifier Business identifier for this product. Could be an MPID
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/eurdId
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
.... identifier:mpId Σ 0..1 EmaMpIdentifier Business identifier for this product. Could be an MPID
ele-1: All FHIR elements must have a @value or children
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://ema.europa.eu/fhir/mpId
..... value ΣC 1..1 string The value that is unique
ele-1: All FHIR elements must have a @value or children
Example General: 123456
... type Σ 1..1 EmaRefTermCodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: Medicinal Product Type (required)
ele-1: All FHIR elements must have a @value or children
... domain Σ 1..1 EmaRefTermCodeableConcept If this medicine applies to human or veterinary uses
Binding: Domain (required)
ele-1: All FHIR elements must have a @value or children
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.


ele-1: All FHIR elements must have a @value or children
... combinedPharmaceuticalDoseForm Σ 1..1 EmaRefTermCodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Combined Pharmaceutical Dose Form (required)
ele-1: All FHIR elements must have a @value or children
... indication Σ 1..1 markdown Description of indication(s) for this product, used when structured indications are not required
ele-1: All FHIR elements must have a @value or children
.... extension 1..1 EmaCoding Language
URL: http://ema.europa.eu/fhir/extension/language
Binding: Language (required)
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
... legalStatusOfSupply Σ 1..1 EmaRefTermCodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: Legal Status of Supply (required)
ele-1: All FHIR elements must have a @value or children
... additionalMonitoringIndicator Σ 1..1 EmaRefTermCodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: Additional Monitoring Indicator (required)
ele-1: All FHIR elements must have a @value or children
... pediatricUseIndicator Σ 1..1 EmaRefTermCodeableConcept If authorised for use in children
Binding: Paediatric Use Indicator (required)
ele-1: All FHIR elements must have a @value or children
... Slices for classification Σ 4..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Closed by value:coding.system
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
.... classification:xevmpd Σ 1..1 EmaXevmpdProductCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
..... extension 0..0
.... classification:legalBasis Σ 1..1 EmaLegalBasisCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
..... extension 0..0
.... classification:lightAtc Σ 1..* EmaLightAtcCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
..... extension 0..0 (Complex)
...... extension:All Slices Content/Rules for all slices
..... coding Σ 1..1 EmaAtcCoding Code defined by a terminology system
ele-1: All FHIR elements must have a @value or children
...... system Σ 1..1 uri Identity of the terminology system
ele-1: All FHIR elements must have a @value or children
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
...... code ΣC 1..1 code Symbol in syntax defined by the system
ele-1: All FHIR elements must have a @value or children
.... classification:productCategory Σ 1..* EmaProductCategoryCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children
..... extension 0..0
... masterFile Σ 1..1 Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
ele-1: All FHIR elements must have a @value or children
... contact Σ 0..1 BackboneElement A product specific contact, person (in a role), or an organization
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type Σ 0..1 EmaQualifiedPersonTypeCodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.


ele-1: All FHIR elements must have a @value or children
.... contact Σ 1..1 Reference(PractitionerRole) A product specific contact, person (in a role), or an organization
ele-1: All FHIR elements must have a @value or children
... name Σ 1..1 BackboneElement The product's name, including full name and possibly coded parts
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... productName Σ 1..1 string The full product name
ele-1: All FHIR elements must have a @value or children
.... type Σ 0..1 EmaRefTermCodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Medicinal Product Name Part Type (required)
ele-1: All FHIR elements must have a @value or children
.... Slices for part Σ 1..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
ele-1: All FHIR elements must have a @value or children
..... part:All Slices Content/Rules for all slices
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... part Σ 1..1 string A fragment of a product name
ele-1: All FHIR elements must have a @value or children
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
ele-1: All FHIR elements must have a @value or children
..... part:inventedName Σ 0..1 BackboneElement Coding words or phrases of the name
ele-1: All FHIR elements must have a @value or children
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... part Σ 1..1 string A fragment of a product name
ele-1: All FHIR elements must have a @value or children
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
..... part:fullName Σ 0..1 BackboneElement Coding words or phrases of the name
ele-1: All FHIR elements must have a @value or children
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... part Σ 1..1 string A fragment of a product name
ele-1: All FHIR elements must have a @value or children
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000001
..... part:pharmaceuticalDoseForm Σ 0..1 BackboneElement Coding words or phrases of the name
ele-1: All FHIR elements must have a @value or children
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
...... part Σ 1..1 string A fragment of a product name
ele-1: All FHIR elements must have a @value or children
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


ele-1: All FHIR elements must have a @value or children
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000005
.... usage Σ 1..1 BackboneElement Country and jurisdiction where the name applies
ele-1: All FHIR elements must have a @value or children
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
..... country Σ 1..1 EmaRefTermCodeableConcept Country code for where this name applies
Binding: Country (required)
ele-1: All FHIR elements must have a @value or children
..... language Σ 1..1 CodeableConcept Language code for this name
Binding: Language (required)
Additional BindingsPurpose
CommonLanguages Starter

ele-1: All FHIR elements must have a @value or children
... crossReference Σ 1..1 BackboneElement Reference to another product, e.g. for linking authorised to investigational product
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
ele-1: All FHIR elements must have a @value or children
.... type Σ 1..1 EmaRefTermCodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: Product Cross Reference Type (required)
ele-1: All FHIR elements must have a @value or children
... characteristic Σ 1..1 BackboneElement Key product features such as "sugar free", "modified release"
ele-1: All FHIR elements must have a @value or children
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
ele-1: All FHIR elements must have a @value or children
ext-1: Must have either extensions or value[x], not both
.... type Σ 1..1 EmaGmoCodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.


ele-1: All FHIR elements must have a @value or children

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.typerequiredMedicinalProductTypeVs (a valid code from Medicinal Product Type)
http://ema.europa.eu/fhir/vs/medicinalProductType
from this IG
MedicinalProductDefinition.domainrequiredDomainVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredCombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)
http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm
from this IG
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.additionalMonitoringIndicatorrequiredAdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator
from this IG
MedicinalProductDefinition.pediatricUseIndicatorrequiredPaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/paediatricUseIndicator
from this IG
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:xevmpdexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:legalBasisexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:lightAtcexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:productCategoryexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.name.typerequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part:inventedName.typeexamplePattern: 220000000002
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:fullName.typeexamplePattern: 220000000001
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.typeexamplePattern: 220000000005
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.usage.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
MedicinalProductDefinition.name.usage.languagerequiredLanguageVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/language
from this IG
MedicinalProductDefinition.crossReference.typerequiredProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)
http://ema.europa.eu/fhir/vs/productcrossreferencetype
from this IG
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

Differential View

This structure is derived from MedicinalProductDefinition

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition MedicinalProductDefinition
... extension 1..* EmaCoding Authorised Dose Form
URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm
Binding: Authorised Dose Form (required)
... Slices for identifier 0..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
.... identifier:All Slices Content/Rules for all slices
..... extension 0..0
..... use 0..0
..... type 0..0
..... period 0..0
..... assigner 0..0
.... identifier:eurdId 0..1 EmaEurdIdentifier Business identifier for this product. Could be an MPID
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/eurdId
.... identifier:mpId 0..1 EmaMpIdentifier Business identifier for this product. Could be an MPID
..... system 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/mpId
... type 1..1 EmaRefTermCodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: Medicinal Product Type (required)
... combinedPharmaceuticalDoseForm 1..1 EmaRefTermCodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Combined Pharmaceutical Dose Form (required)
... indication 1..1 markdown Description of indication(s) for this product, used when structured indications are not required
.... extension 1..1 EmaCoding Language
URL: http://ema.europa.eu/fhir/extension/language
Binding: Language (required)
... legalStatusOfSupply 1..1 EmaRefTermCodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: Legal Status of Supply (required)
... additionalMonitoringIndicator 1..1 EmaRefTermCodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: Additional Monitoring Indicator (required)
... pediatricUseIndicator 1..1 EmaRefTermCodeableConcept If authorised for use in children
Binding: Paediatric Use Indicator (required)
... Slices for classification 4..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Closed by value:coding.system
.... classification:xevmpd 1..1 EmaXevmpdProductCodeableConcept Allows the product to be classified by various systems
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324
.... classification:legalBasis 1..1 EmaLegalBasisCodeableConcept Allows the product to be classified by various systems
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045
.... classification:lightAtc 1..* EmaLightAtcCodeableConcept Allows the product to be classified by various systems
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
.... classification:productCategory 1..* EmaProductCategoryCodeableConcept Allows the product to be classified by various systems
..... coding
...... system 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526
... masterFile 1..1 Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact 0..1 BackboneElement A product specific contact, person (in a role), or an organization
.... type 0..1 EmaQualifiedPersonTypeCodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
.... contact 1..1 Reference(PractitionerRole) A product specific contact, person (in a role), or an organization
... name 1..1 BackboneElement The product's name, including full name and possibly coded parts
.... type 0..1 EmaRefTermCodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Medicinal Product Name Part Type (required)
.... Slices for part 1..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... type
....... coding 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
..... part:inventedName 0..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
..... part:fullName 0..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000001
..... part:pharmaceuticalDoseForm 0..1 BackboneElement Coding words or phrases of the name
...... type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Required Pattern: At least the following
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000005
.... usage 1..1 BackboneElement Country and jurisdiction where the name applies
..... country 1..1 EmaRefTermCodeableConcept Country code for where this name applies
Binding: Country (required)
..... language 1..1 CodeableConcept Language code for this name
Binding: Language (required)
... crossReference 1..1 BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... product
..... reference
...... identifier 1..1 Identifier Logical reference, when literal reference is not known
....... system 0..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/crossReference
.... type 1..1 EmaRefTermCodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: Product Cross Reference Type (required)
... operation
.... type 0..1 CodeableReference(EMA Write API ActivityDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... confidentialityIndicator 0..1 EmaRefTermCodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: Data Classification (required)
... characteristic 1..1 BackboneElement Key product features such as "sugar free", "modified release"
.... type 1..1 EmaGmoCodeableConcept A code expressing the type of characteristic

doco Documentation for this format

Terminology Bindings (Differential)

PathConformanceValueSetURI
MedicinalProductDefinition.typerequiredMedicinalProductTypeVs (a valid code from Medicinal Product Type)
http://ema.europa.eu/fhir/vs/medicinalProductType
from this IG
MedicinalProductDefinition.domainrequiredDomainVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredCombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)
http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm
from this IG
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.additionalMonitoringIndicatorrequiredAdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator
from this IG
MedicinalProductDefinition.pediatricUseIndicatorrequiredPaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/paediatricUseIndicator
from this IG
MedicinalProductDefinition.name.typerequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.usage.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
MedicinalProductDefinition.name.usage.languagerequiredLanguageVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/language
from this IG
MedicinalProductDefinition.crossReference.typerequiredProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)
http://ema.europa.eu/fhir/vs/productcrossreferencetype
from this IG
MedicinalProductDefinition.operation.confidentialityIndicatorrequiredDataClassificationVs (a valid code from Data Classification)
http://ema.europa.eu/fhir/vs/dataClassification
from this IG

Snapshot View

NameFlagsCard.TypeDescription & Constraintsdoco
.. MedicinalProductDefinition 0..* MedicinalProductDefinition Detailed definition of a medicinal product
... id Σ 0..1 id Logical id of this artifact
... meta Σ 0..1 Meta Metadata about the resource
... implicitRules ?!Σ 0..1 uri A set of rules under which this content was created
... language 0..1 code Language of the resource content
Binding: AllLanguages (required): IETF language tag for a human language

Additional BindingsPurpose
CommonLanguages Starter
... text 0..1 Narrative Text summary of the resource, for human interpretation
... contained 0..* Resource Contained, inline Resources
... extension 1..* EmaCoding Authorised Dose Form
URL: http://ema.europa.eu/fhir/extension/authorisedDoseForm
Binding: Authorised Dose Form (required)
... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored
... Slices for identifier Σ 0..* Identifier Business identifier for this product. Could be an MPID
Slice: Unordered, Closed by value:system
.... identifier:All Slices Content/Rules for all slices
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 0..1 uri The namespace for the identifier value
Example General: http://www.acme.com/identifiers/patient
..... value ΣC 0..1 string The value that is unique
Example General: 123456
.... identifier:eurdId Σ 0..1 EmaEurdIdentifier Business identifier for this product. Could be an MPID
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/eurdId
..... value ΣC 1..1 string The value that is unique
Example General: 123456
.... identifier:mpId Σ 0..1 EmaMpIdentifier Business identifier for this product. Could be an MPID
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... system Σ 1..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/mpId
..... value ΣC 1..1 string The value that is unique
Example General: 123456
... type Σ 1..1 EmaRefTermCodeableConcept Regulatory type, e.g. Investigational or Authorized
Binding: Medicinal Product Type (required)
... domain Σ 1..1 EmaRefTermCodeableConcept If this medicine applies to human or veterinary uses
Binding: Domain (required)
... version Σ 0..1 string A business identifier relating to a specific version of the product
... status ?!Σ 0..1 CodeableConcept The status within the lifecycle of this product record
Binding: PublicationStatus (preferred): The lifecycle status of an artifact.

... statusDate Σ 0..1 dateTime The date at which the given status became applicable
... description Σ 0..1 markdown General description of this product
... combinedPharmaceuticalDoseForm Σ 1..1 EmaRefTermCodeableConcept The dose form for a single part product, or combined form of a multiple part product
Binding: Combined Pharmaceutical Dose Form (required)
... route Σ 0..* CodeableConcept The path by which the product is taken into or makes contact with the body
Binding: SNOMEDCTRouteCodes (example): A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.


... indication Σ 1..1 markdown Description of indication(s) for this product, used when structured indications are not required
.... id 0..1 string xml:id (or equivalent in JSON)
.... extension 1..1 EmaCoding Language
URL: http://ema.europa.eu/fhir/extension/language
Binding: Language (required)
.... value 0..1 markdown Primitive value for markdown
... legalStatusOfSupply Σ 1..1 EmaRefTermCodeableConcept The legal status of supply of the medicinal product as classified by the regulator
Binding: Legal Status of Supply (required)
... additionalMonitoringIndicator Σ 1..1 EmaRefTermCodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Binding: Additional Monitoring Indicator (required)
... specialMeasures Σ 0..* CodeableConcept Whether the Medicinal Product is subject to special measures for regulatory reasons
Binding: SpecialMeasures (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.


... pediatricUseIndicator Σ 1..1 EmaRefTermCodeableConcept If authorised for use in children
Binding: Paediatric Use Indicator (required)
... Slices for classification Σ 4..* CodeableConcept Allows the product to be classified by various systems
Slice: Unordered, Closed by value:coding.system
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


.... classification:xevmpd Σ 1..1 EmaXevmpdProductCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: XEVMPD medicinal product type (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/200000000324
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... classification:legalBasis Σ 1..1 EmaLegalBasisCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: XEVMPD medicinal product type (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000116045
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
.... classification:lightAtc Σ 1..* EmaLightAtcCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0 (Complex)
...... extension:All Slices Content/Rules for all slices
..... coding Σ 1..1 EmaAtcCoding Code defined by a terminology system
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000093533
....... id 0..1 string xml:id (or equivalent in JSON)
....... extension 0..* string Extension
URL: http://ema.europa.eu/fhir/extension/codeSystemName
....... value 0..1 uri Primitive value for uri
...... code ΣC 1..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
.... classification:productCategory Σ 1..* EmaProductCategoryCodeableConcept Allows the product to be classified by various systems
Binding: ProductClassification (example): This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.


..... id 0..1 id Unique id for inter-element referencing
..... extension 0..0
..... coding Σ 0..* Coding Code defined by a terminology system
Binding: Product Category (required)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... system Σ 1..1 uri Identity of the terminology system
Required Pattern: http://spor.ema.europa.eu/v1/lists/100000155526
...... version Σ 0..1 string Version of the system - if relevant
...... code ΣC 0..1 code Symbol in syntax defined by the system
...... display ΣC 0..1 string Representation defined by the system
...... userSelected Σ 0..1 boolean If this coding was chosen directly by the user
... marketingStatus Σ 0..* MarketingStatus Marketing status of the medicinal product, in contrast to marketing authorization
... packagedMedicinalProduct Σ 0..* CodeableConcept Package type for the product
Binding: MedicinalProductPackageType (example): Types of medicinal product packs


... comprisedOf Σ 0..* Reference(ManufacturedItemDefinition | DeviceDefinition) Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
... ingredient Σ 0..* CodeableConcept The ingredients of this medicinal product - when not detailed in other resources
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... impurity Σ 0..* CodeableReference(SubstanceDefinition) Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Binding: SNOMEDCTSubstanceCodes (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.


... attachedDocument Σ 0..* Reference(DocumentReference) Additional documentation about the medicinal product
... masterFile Σ 1..1 Reference(DocumentReference) A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
... contact Σ 0..1 BackboneElement A product specific contact, person (in a role), or an organization
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 EmaQualifiedPersonTypeCodeableConcept Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Binding: ProductContactType (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.

.... contact Σ 1..1 Reference(PractitionerRole) A product specific contact, person (in a role), or an organization
... clinicalTrial Σ 0..* Reference(ResearchStudy) Clinical trials or studies that this product is involved in
... code Σ 0..* Coding A code that this product is known by, within some formal terminology
Binding: SNOMEDCTMedicationCodes (example): A coded concept that defines the type of a medication.


... name Σ 1..1 BackboneElement The product's name, including full name and possibly coded parts
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... productName Σ 1..1 string The full product name
.... type Σ 0..1 EmaRefTermCodeableConcept Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Binding: Medicinal Product Name Part Type (required)
.... Slices for part Σ 1..* BackboneElement Coding words or phrases of the name
Slice: Unordered, Open by value:type
..... part:All Slices Content/Rules for all slices
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.

....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
....... text Σ 0..1 string Plain text representation of the concept
..... part:inventedName Σ 0..1 BackboneElement Coding words or phrases of the name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000002
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
....... text Σ 0..1 string Plain text representation of the concept
..... part:fullName Σ 0..1 BackboneElement Coding words or phrases of the name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000001
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
....... text Σ 0..1 string Plain text representation of the concept
..... part:pharmaceuticalDoseForm Σ 0..1 BackboneElement Coding words or phrases of the name
...... id 0..1 string Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
...... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
...... part Σ 1..1 string A fragment of a product name
...... type Σ 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part)
Binding: ProductNamePartType (example): Type of part of a name for a Medicinal Product.


Required Pattern: At least the following
....... id 0..1 string Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
....... coding 1..* Coding Code defined by a terminology system
Fixed Value: (complex)
........ id 0..1 string Unique id for inter-element referencing
........ extension 0..* Extension Additional content defined by implementations
........ system 1..1 uri Identity of the terminology system
Fixed Value: http://spor.ema.europa.eu/v1/lists/220000000000
........ version 0..1 string Version of the system - if relevant
........ code 1..1 code Symbol in syntax defined by the system
Fixed Value: 220000000005
........ display 0..1 string Representation defined by the system
........ userSelected 0..1 boolean If this coding was chosen directly by the user
....... text 0..1 string Plain text representation of the concept
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... coding Σ 0..* EmaNamePartTypeCoding Code defined by a terminology system
Binding: Medicinal Product Name Part Type (required)
....... text Σ 0..1 string Plain text representation of the concept
.... usage Σ 1..1 BackboneElement Country and jurisdiction where the name applies
..... id 0..1 string Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
..... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
..... country Σ 1..1 EmaRefTermCodeableConcept Country code for where this name applies
Binding: Country (required)
..... jurisdiction Σ 0..1 CodeableConcept Jurisdiction code for where this name applies
Binding: JurisdictionValueSet (example): Jurisdiction codes

..... language Σ 1..1 CodeableConcept Language code for this name
Binding: Language (required)
Additional BindingsPurpose
CommonLanguages Starter
... crossReference Σ 1..1 BackboneElement Reference to another product, e.g. for linking authorised to investigational product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... product Σ 1..1 CodeableReference(MedicinalProductDefinition) Reference to another product, e.g. for linking authorised to investigational product
..... id 0..1 id Unique id for inter-element referencing
..... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
..... concept Σ 0..1 CodeableConcept Reference to a concept (by class)
..... reference Σ 0..1 Reference() Reference to a resource (by instance)
...... id 0..1 id Unique id for inter-element referencing
...... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
...... reference ΣC 0..1 string Literal reference, Relative, internal or absolute URL
...... type Σ 0..1 uri Type the reference refers to (e.g. "Patient") - must be a resource in resources
Binding: ResourceType (extensible): Aa resource (or, for logical models, the URI of the logical model).

...... identifier ΣC 1..1 Identifier Logical reference, when literal reference is not known
....... id 0..1 id Unique id for inter-element referencing
....... extension 0..* Extension Additional content defined by implementations
Slice: Unordered, Open by value:url
....... use ?!Σ 0..1 code usual | official | temp | secondary | old (If known)
Binding: IdentifierUse (required): Identifies the purpose for this identifier, if known .

....... type Σ 0..1 CodeableConcept Description of identifier
Binding: IdentifierTypeCodes (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.

....... system Σ 0..1 uri The namespace for the identifier value
Required Pattern: http://ema.europa.eu/fhir/crossReference
....... value ΣC 0..1 string The value that is unique
Example General: 123456
....... period Σ 0..1 Period Time period when id is/was valid for use
....... assigner Σ 0..1 Reference(Organization) Organization that issued id (may be just text)
...... display ΣC 0..1 string Text alternative for the resource
.... type Σ 1..1 EmaRefTermCodeableConcept The type of relationship, for instance branded to generic or virtual to actual product
Binding: Product Cross Reference Type (required)
... operation Σ 0..* BackboneElement A manufacturing or administrative process for the medicinal product
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 0..1 CodeableReference(EMA Write API ActivityDefinition) The type of manufacturing operation e.g. manufacturing itself, re-packaging
.... effectiveDate Σ 0..1 Period Date range of applicability
.... organization Σ 0..* Reference(Organization) The organization responsible for the particular process, e.g. the manufacturer or importer
.... confidentialityIndicator Σ 0..1 EmaRefTermCodeableConcept Specifies whether this process is considered proprietary or confidential
Binding: Data Classification (required)
... characteristic Σ 1..1 BackboneElement Key product features such as "sugar free", "modified release"
.... id 0..1 string Unique id for inter-element referencing
.... extension 0..* Extension Additional content defined by implementations
.... modifierExtension ?!Σ 0..* Extension Extensions that cannot be ignored even if unrecognized
.... type Σ 1..1 EmaGmoCodeableConcept A code expressing the type of characteristic
Binding: ProductCharacteristic (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.

.... value[x] Σ 0..1 A value for the characteristic
..... valueCodeableConcept CodeableConcept
..... valueMarkdown markdown
..... valueQuantity Quantity
..... valueInteger integer
..... valueDate date
..... valueBoolean boolean
..... valueAttachment Attachment

doco Documentation for this format

Terminology Bindings

PathConformanceValueSet / CodeURI
MedicinalProductDefinition.languagerequiredAllLanguages
http://hl7.org/fhir/ValueSet/all-languages|5.0.0
from the FHIR Standard
MedicinalProductDefinition.typerequiredMedicinalProductTypeVs (a valid code from Medicinal Product Type)
http://ema.europa.eu/fhir/vs/medicinalProductType
from this IG
MedicinalProductDefinition.domainrequiredDomainVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/domain
from this IG
MedicinalProductDefinition.statuspreferredPublicationStatus
http://hl7.org/fhir/ValueSet/publication-status
from the FHIR Standard
MedicinalProductDefinition.combinedPharmaceuticalDoseFormrequiredCombinedPharmaceuticalDoseFormVs (a valid code from Combined Pharmaceutical Dose Form)
http://ema.europa.eu/fhir/vs/combinedpharmaceuticalDoseForm
from this IG
MedicinalProductDefinition.routeexampleSNOMEDCTRouteCodes
http://hl7.org/fhir/ValueSet/route-codes
from the FHIR Standard
MedicinalProductDefinition.legalStatusOfSupplyrequiredLegalStatusForTheSupplyVs (a valid code from Legal Status From the Supply)
http://ema.europa.eu/fhir/vs/legalStatusForTheSupply
from this IG
MedicinalProductDefinition.additionalMonitoringIndicatorrequiredAdditionalMonitoringIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/additionalMonitoringIndicator
from this IG
MedicinalProductDefinition.specialMeasuresexampleSpecialMeasures
http://hl7.org/fhir/ValueSet/medicinal-product-special-measures
from the FHIR Standard
MedicinalProductDefinition.pediatricUseIndicatorrequiredPaediatricUseIndicatorVs (a valid code from Additional Monitoring Indicator)
http://ema.europa.eu/fhir/vs/paediatricUseIndicator
from this IG
MedicinalProductDefinition.classificationexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:xevmpdexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:xevmpd.codingrequiredXevmpdMedicinalProductTypeVs (a valid code from XEVMPD Medicinal Product Type)
http://ema.europa.eu/fhir/vs/xevmpdMedicinalProductType
from this IG
MedicinalProductDefinition.classification:legalBasisexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:legalBasis.codingrequiredMarketingAuthorisationApplicationLegalBasisVs (a valid code from Marketing Authorisation Application Legal Basis)
http://ema.europa.eu/fhir/vs/marketingAuthorisationApplicationLegalBasis
from this IG
MedicinalProductDefinition.classification:lightAtcexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:productCategoryexampleProductClassification
http://hl7.org/fhir/ValueSet/medicinal-product-classification
from the FHIR Standard
MedicinalProductDefinition.classification:productCategory.codingrequiredProductCategoryVs (a valid code from Product Category)
http://ema.europa.eu/fhir/vs/productCategory
from this IG
MedicinalProductDefinition.packagedMedicinalProductexampleMedicinalProductPackageType
http://hl7.org/fhir/ValueSet/medicinal-product-package-type
from the FHIR Standard
MedicinalProductDefinition.ingredientexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.impurityexampleSNOMEDCTSubstanceCodes
http://hl7.org/fhir/ValueSet/substance-codes
from the FHIR Standard
MedicinalProductDefinition.contact.typeexampleProductContactType
http://hl7.org/fhir/ValueSet/medicinal-product-contact-type
from the FHIR Standard
MedicinalProductDefinition.codeexampleSNOMEDCTMedicationCodes
http://hl7.org/fhir/ValueSet/medication-codes
from the FHIR Standard
MedicinalProductDefinition.name.typerequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part.typeexampleProductNamePartType
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part:inventedName.typeexamplePattern: 220000000002
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:inventedName.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part:fullName.typeexamplePattern: 220000000001
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:fullName.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.typeexamplePattern: 220000000005
http://hl7.org/fhir/ValueSet/medicinal-product-name-part-type
from the FHIR Standard
MedicinalProductDefinition.name.part:pharmaceuticalDoseForm.type.codingrequiredMedicinalProductNamePartTypeVs (a valid code from Medicinal Product Name Part Type)
http://ema.europa.eu/fhir/vs/productNamePartType
from this IG
MedicinalProductDefinition.name.usage.countryrequiredCountryVs (a valid code from Country)
http://ema.europa.eu/fhir/vs/country
from this IG
MedicinalProductDefinition.name.usage.jurisdictionexampleJurisdictionValueSet
http://hl7.org/fhir/ValueSet/jurisdiction
from the FHIR Standard
MedicinalProductDefinition.name.usage.languagerequiredLanguageVs (a valid code from Domain)
http://ema.europa.eu/fhir/vs/language
from this IG
MedicinalProductDefinition.crossReference.product.reference.typeextensibleResourceType
http://hl7.org/fhir/ValueSet/resource-types
from the FHIR Standard
MedicinalProductDefinition.crossReference.product.reference.identifier.userequiredIdentifierUse
http://hl7.org/fhir/ValueSet/identifier-use|5.0.0
from the FHIR Standard
MedicinalProductDefinition.crossReference.product.reference.identifier.typeextensibleIdentifierTypeCodes
http://hl7.org/fhir/ValueSet/identifier-type
from the FHIR Standard
MedicinalProductDefinition.crossReference.typerequiredProductCrossReferenceTypeVs (a valid code from Product Cross Reference Type)
http://ema.europa.eu/fhir/vs/productcrossreferencetype
from this IG
MedicinalProductDefinition.operation.confidentialityIndicatorrequiredDataClassificationVs (a valid code from Data Classification)
http://ema.europa.eu/fhir/vs/dataClassification
from this IG
MedicinalProductDefinition.characteristic.typeexampleProductCharacteristic
http://hl7.org/fhir/ValueSet/product-characteristic-codes
from the FHIR Standard

This structure is derived from MedicinalProductDefinition

Summary

Mandatory: 20 elements(6 nested mandatory elements)
Prohibited: 5 elements

Structures

This structure refers to these other structures:

Extensions

This structure refers to these extensions:

Slices

This structure defines the following Slices:

  • The element 1 is sliced based on the value of MedicinalProductDefinition.identifier (Closed)
  • The element 1 is sliced based on the value of MedicinalProductDefinition.classification (Closed)
  • The element 1 is sliced based on the value of MedicinalProductDefinition.name.part

 

Other representations of profile: CSV, Excel, Schematron