Profile Comparison between http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi vs http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi

Messages

Metadata

Name	Value		Comments
abstract	false
baseDefinition	http://hl7.org/fhir/StructureDefinition/MedicinalProductDefinition
copyright
date	2022-12-04T18:49:33+00:00	2023-07-26T13:32:34+00:00	Values Differ
description	Description of the packaged authorized medicinal product(s) associated to this ePI document.
experimental
fhirVersion	5.0.0-ballot	5.0.0	Values Differ
jurisdiction
jurisdiction[0]	http://unstats.un.org/unsd/methods/m49/m49.htm#001
kind	resource
name	MedicinalProductDefinitionUvEpi
publisher		HL7 International - Biomedical Research & Regulation Work Group	Added the item 'HL7 International - Biomedical Research & Regulation Work Group'
purpose
status	active
title	MedicinalProductDefinition (ePI)
type	MedicinalProductDefinition
url	http://hl7.org/fhir/uv/emedicinal-product-info/StructureDefinition/MedicinalProductDefinition-uv-epi
version	1.0.0-ballot	1.0.0	Values Differ

Structure

Name	L Flags	L Card.	L Type	L Description & Constraints	R Flags	R Card.	L Type	L Description & Constraints	Comments
MedicinalProductDefinition		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product		0..*	MedicinalProductDefinition	Detailed definition of a medicinal product
id	Σ	0..1	id	Logical id of this artifact	Σ	0..1	id	Logical id of this artifact
meta	Σ	0..1	Meta	Metadata about the resource	Σ	0..1	Meta	Metadata about the resource
implicitRules	?!Σ	0..1	uri	A set of rules under which this content was created	?!Σ	0..1	uri	A set of rules under which this content was created	Elements differ in comments: 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of it's narrative along with other profiles, value sets, etc.' vs 'Asserting this rule set restricts the content to be only understood by a limited set of trading partners. This inherently limits the usefulness of the data in the long term. However, the existing health eco-system is highly fractured, and not yet ready to define, collect, and exchange data in a generally computable sense. Wherever possible, implementers and/or specification writers should avoid using this element. Often, when used, the URL is a reference to an implementation guide that defines these special rules as part of its narrative along with other profiles, value sets, etc.'
language		0..1	code	Language of the resource content Binding: ?? (preferred): IETF language tag Additional Bindings Purpose ?? Max Binding		0..1	code	Language of the resource content Binding: ?? (required): IETF language tag for a human language	Elements differ in binding.description: 'IETF language tag' vs 'IETF language tag for a human language'
text		0..1	Narrative	Text summary of the resource, for human interpretation		0..1	Narrative	Text summary of the resource, for human interpretation
contained		0..*	Resource	Contained, inline Resources		0..*	Resource	Contained, inline Resources
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the resource. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored	?!Σ	0..*	Extension	Extensions that cannot be ignored	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the resource and that modifies the understanding of the element that contains it and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
identifier	Σ	1..*	Identifier	Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID).	Σ	1..*	Identifier	Business identifier for this product. Could be an MPID	Elements differ in short: 'Unique identifier assigned to this medicinal product by the health authority. Could be the ISO IDMP Medicinal Product Identifier (MPID).' vs 'Business identifier for this product. Could be an MPID'
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
use	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required)	?!Σ	0..1	code	usual | official | temp | secondary | old (If known) Binding: ?? (required): Identifies the purpose for this identifier, if known .
type	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible)	Σ	0..1	CodeableConcept	Description of identifier Binding: ?? (extensible): A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
system	Σ	1..1	uri	The namespace for the identifier value Binding: ?? (extensible) Example General: http://www.acme.com/identifiers/patient	Σ	1..1	uri	The namespace for the identifier value Example General: http://www.acme.com/identifiers/patient	Elements differ in definition: 'Establishes the namespace for the value - that is, a absolute URL that describes a set values that are unique.' vs 'Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.'
value	Σ	1..1	string	The value that is unique Example General: 123456	ΣC	1..1	string	The value that is unique Example General: 123456	Elements differ in comments: 'If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [Rendered Value extension]. Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.' vs 'If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value]). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.'
period	Σ	0..1	Period	Time period when id is/was valid for use	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)	Σ	0..1	Reference(Organization)	Organization that issued id (may be just text)
type	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized Binding: ?? (preferred)	Σ	0..1	CodeableConcept	Regulatory type, e.g. Investigational or Authorized. Binding: ?? (example): Overall defining type of this medicinal product.	Elements differ in short: 'Regulatory type, e.g. Investigational or Authorized' vs 'Regulatory type, e.g. Investigational or Authorized.' Example/preferred bindings differ at MedicinalProductDefinition.type using binding from MedicinalProductDefinitionUvEpi
domain	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses Binding: ?? (preferred)	Σ	0..1	CodeableConcept	If this medicine applies to human or veterinary uses. Binding: ?? (example)	Elements differ in short: 'If this medicine applies to human or veterinary uses' vs 'If this medicine applies to human or veterinary uses.'
version	Σ	0..1	string	Business version of this product	Σ	0..1	string	A business identifier relating to a specific version of the product.	Elements differ in short: 'Business version of this product' vs '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: ?? (preferred)	?!Σ	0..1	CodeableConcept	The status within the lifecycle of this product record. Binding: ?? (preferred): The lifecycle status of an artifact.	Elements differ in short: 'The status within the lifecycle of this product record' vs 'The status within the lifecycle of this product record.'
statusDate	Σ	0..1	dateTime	The date at which this status became applicable.	Σ	0..1	dateTime	The date at which this status became applicable.
description	Σ	0..1	markdown	General description of the medicinal product referred by the ePI	Σ	0..1	markdown	General description of the medicinal product referred by the ePI
combinedPharmaceuticalDoseForm	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: ?? (preferred)	Σ	0..1	CodeableConcept	The dose form for a single part product, or combined form of a multiple part product Binding: ?? (example)	Example/preferred bindings differ at MedicinalProductDefinition.combinedPharmaceuticalDoseForm using binding from MedicinalProductDefinitionUvEpi
route	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: ?? (preferred)	Σ	0..*	CodeableConcept	The path by which the product is taken into or makes contact with the body Binding: ?? (example)
indication	Σ	0..1	markdown	Narrative text of the authorized indication(s) for this product.	Σ	0..1	markdown	Narrative text of the authorized indication(s) for this product.
legalStatusOfSupply	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator Binding: ?? (preferred)	Σ	0..1	CodeableConcept	The legal status of supply of the medicinal product as classified by the regulator. Binding: ?? (example): The prescription supply types appropriate to a medicinal product	Elements differ in short: 'The legal status of supply of the medicinal product as classified by the regulator' vs 'The legal status of supply of the medicinal product as classified by the regulator.' Example/preferred bindings differ at MedicinalProductDefinition.legalStatusOfSupply using binding from MedicinalProductDefinitionUvEpi
additionalMonitoringIndicator	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: ?? (preferred)	Σ	0..1	CodeableConcept	Whether the Medicinal Product is subject to additional monitoring for regulatory reasons. Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements (e.g. Black Triangle Monitoring).	Elements differ in short: 'Whether the Medicinal Product is subject to additional monitoring for regulatory reasons' vs 'Whether the Medicinal Product is subject to additional monitoring for regulatory reasons.' Example/preferred bindings differ at MedicinalProductDefinition.additionalMonitoringIndicator using binding from MedicinalProductDefinitionUvEpi
specialMeasures	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons Binding: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies.	Σ	0..*	CodeableConcept	Whether the Medicinal Product is subject to special measures for regulatory reasons. Binding: ?? (example): Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.	Elements differ in short: 'Whether the Medicinal Product is subject to special measures for regulatory reasons' vs 'Whether the Medicinal Product is subject to special measures for regulatory reasons.' Elements differ in definition: 'Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorisation studies.' vs 'Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.' Elements differ in binding.description: 'Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorisation studies.' vs 'Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.'
pediatricUseIndicator	Σ	0..1	CodeableConcept	If authorised for use in children Binding: ?? (preferred)	Σ	0..1	CodeableConcept	If authorised for pediatric use Binding: ?? (example): Suitability for age groups, in particular children.	Elements differ in short: 'If authorised for use in children' vs 'If authorised for pediatric use' Example/preferred bindings differ at MedicinalProductDefinition.pediatricUseIndicator using binding from MedicinalProductDefinitionUvEpi
classification	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems Binding: ?? (preferred)	Σ	0..*	CodeableConcept	Allows the product to be classified by various systems (e.g. ATC) Binding: ?? (example)	Elements differ in short: 'Allows the product to be classified by various systems' vs 'Allows the product to be classified by various systems (e.g. ATC)'
marketingStatus	Σ	0..*	MarketingStatus	Marketing status of the medicinal product in contrast to marketing authorization	Σ	0..*	MarketingStatus	Marketing status of the medicinal product, in contrast to marketing authorization	Elements differ in short: 'Marketing status of the medicinal product in contrast to marketing authorization' vs 'Marketing status of the medicinal product, in contrast to marketing authorization'
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
country	Σ	0..1	CodeableConcept	The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements	Σ	0..1	CodeableConcept	The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements Binding: ?? (preferred)	Elements differ in short: 'The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements' vs 'The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements' Elements differ in definition: 'The country in which the marketing authorisation has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.' vs 'The country in which the marketing authorization has been granted shall be specified It should be specified using the ISO 3166 ‑ 1 alpha-2 code elements.'
jurisdiction	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified	Σ	0..1	CodeableConcept	Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified	Elements differ in short: 'Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified' vs 'Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified' Elements differ in definition: 'Where a Medicines Regulatory Agency has granted a marketing authorisation for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.' vs 'Where a Medicines Regulatory Agency has granted a marketing authorization for which specific provisions within a jurisdiction apply, the jurisdiction can be specified using an appropriate controlled terminology The controlled term and the controlled term identifier shall be specified.'
status	Σ	1..1	CodeableConcept	This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples Binding: ?? (preferred)	Σ	1..1	CodeableConcept	Status of the marketing of the medicinal product.	Elements differ in short: 'This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples' vs 'Status of the marketing of the medicinal product.'
dateRange	Σ	0..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain	Σ	0..1	Period	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder	Elements differ in short: 'The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain' vs 'The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder' Elements differ in definition: 'The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.' vs 'The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.'
restoreDate	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain	Σ	0..1	dateTime	The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain	Elements differ in short: 'The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain' vs 'The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain' Elements differ in definition: 'The date when the Medicinal Product is placed on the market by the Marketing Authorisation Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.' vs 'The date when the Medicinal Product is placed on the market by the Marketing Authorization Holder (or where applicable, the manufacturer/distributor) in a country and/or jurisdiction shall be provided A complete date consisting of day, month and year shall be specified using the ISO 8601 date format NOTE “Placed on the market” refers to the release of the Medicinal Product into the distribution chain.'
packagedMedicinalProduct	Σ	0..*	CodeableConcept	High level package type for this product. E.g., sample pack Binding: ?? (preferred)	Σ	0..*	CodeableConcept	Package type for the product. Binding: ?? (example): Types of medicinal product packs	Elements differ in short: 'High level package type for this product. E.g., sample pack' vs 'Package type for the product.' Example/preferred bindings differ at MedicinalProductDefinition.packagedMedicinalProduct using binding from MedicinalProductDefinitionUvEpi
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	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: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	Σ	0..*	CodeableConcept	The ingredients of this medicinal product - when not detailed in other resources Binding: ?? (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: ?? (example): This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.	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: ?? (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	Σ	0..*	Reference(DocumentReference)	Additional documentation about the medicinal product
masterFile	Σ	0..*	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)	Σ	0..*	Reference(DocumentReference)	A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
contact	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization	Σ	0..*	BackboneElement	A product specific contact, person (in a role), or an organization
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
type	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.	Σ	0..1	CodeableConcept	Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information. Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.	Elements differ in short: 'Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information' vs 'Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.'
contact	Σ	1..1	Reference(Organization | PractitionerRole)	A product specific contact, person (in a role), or an organization	Σ	1..1	Reference(Organization | PractitionerRole)	A specific contact, person (in a role), or an organization for this product	Elements differ in short: 'A product specific contact, person (in a role), or an organization' vs 'A specific contact, person (in a role), or an organization for this product'
clinicalTrial	Σ	0..*	Reference(ResearchStudy)	Clinical trials or studies that this product is involved in	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: ?? (example): A coded concept that defines the type of a medication.	Σ	0..*	Coding	A code that this product is known by, within some formal terminology Binding: ?? (example): A coded concept that defines the type of a medication.
name	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts	Σ	1..*	BackboneElement	The product's name, including full name and possibly coded parts
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
productName	Σ	1..1	string	The full name of this product Example general: Humalog Mix50 Insulin KwikPen, 3 ml pre-fill	Σ	1..1	string	The full product name.	Elements differ in short: 'The full name of this product' vs 'The full product name.'
type	Σ	0..1	CodeableConcept	Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary Binding: ?? (example): Type of a name for a Medicinal Product. Required Pattern: {"coding":[{"system":"https://spor.ema.europa.eu/rmswi/220000000000","code":"220000000001"}]}	Σ	0..1	CodeableConcept	Type of product name, such as rINN, Proprietary, Non-Proprietary Binding: ?? (example): Type of a name for a Medicinal Product.	Elements differ in short: 'Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary' vs 'Type of product name, such as rINN, Proprietary, Non-Proprietary'
Slices for part	Σ	0..*	BackboneElement	Coding words or phrases of the name Slice: Unordered, Open by pattern:type	Σ	0..*	BackboneElement	Coding words or phrases of the name
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
part	Σ	1..1	string	A fragment of a product name	Σ	1..1	string	A fragment of a product name.	Elements differ in short: 'A fragment of a product name' vs 'A fragment of a product name.'
type	Σ	1..1	CodeableConcept	Identifying type for this part of the name (e.g. strength part) Binding: ?? (example): Type of part of a name for a Medicinal Product.	Σ	1..1	CodeableConcept	Type for this part of the name (e.g. strength part) Binding: ?? (example): Type of part of a name for a Medicinal Product.	Elements differ in short: 'Identifying type for this part of the name (e.g. strength part)' vs 'Type for this part of the name (e.g. strength part)'
usage	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies	Σ	0..*	BackboneElement	Country and jurisdiction where the name applies
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
country	Σ	1..1	CodeableConcept	Country code for where this name applies Binding: ?? (preferred)	Σ	1..1	CodeableConcept	Country where this name applies Binding: ?? (example): Jurisdiction codes	Elements differ in short: 'Country code for where this name applies' vs 'Country where this name applies' Example/preferred bindings differ at MedicinalProductDefinition.name.usage.country using binding from MedicinalProductDefinitionUvEpi
jurisdiction	Σ	0..1	CodeableConcept	Jurisdiction code for where this name applies Binding: ?? (preferred)	Σ	0..1	CodeableConcept	Jurisdiction where this name applies Binding: ?? (example): Jurisdiction codes	Elements differ in short: 'Jurisdiction code for where this name applies' vs 'Jurisdiction where this name applies' Example/preferred bindings differ at MedicinalProductDefinition.name.usage.jurisdiction using binding from MedicinalProductDefinitionUvEpi
language	Σ	1..1	CodeableConcept	Language code for this name Binding: ?? (preferred): IETF language tag Additional Bindings Purpose ?? Max Binding	Σ	1..1	CodeableConcept	Language for this name Binding: ?? (required): IETF language tag for a human language	Elements differ in short: 'Language code for this name' vs 'Language for this name' Elements differ in binding.description: 'IETF language tag' vs 'IETF language tag for a human language'
crossReference	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product	Σ	0..*	BackboneElement	Reference to another product, e.g. for linking authorised to investigational product
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
product	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product	Σ	1..1	CodeableReference(MedicinalProductDefinition)	Reference to another product, e.g. for linking authorised to investigational product
type	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ?? (extensible)	Σ	0..1	CodeableConcept	The type of relationship, for instance branded to generic or virtual to actual product Binding: ?? (example): Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
operation	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product	Σ	0..*	BackboneElement	A manufacturing or administrative process for the medicinal product
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
type	Σ	0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging Binding: ?? (preferred)	Σ	0..1	CodeableReference(ActivityDefinition | PlanDefinition)	The type of manufacturing operation e.g. manufacturing itself, re-packaging
id		0..1	id	Unique id for inter-element referencing		0..1	id	Unique id for inter-element referencing
Slices for extension		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url		0..*	Extension	Additional content defined by implementations Slice: Unordered, Open by value:url	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
concept	Σ	1..1	CodeableConcept	Reference to a concept (by class)	Σ	0..1	CodeableConcept	Reference to a concept (by class)	Element minimum cardinalities differ: '1' vs '0'
reference	Σ	0..1	Reference()	Reference to a resource (by instance)	Σ	0..1	Reference()	Reference to a resource (by instance)
effectiveDate	Σ	0..1	Period	Date range of applicability	Σ	0..1	Period	Date range of applicability
organization	Σ	0..*	Reference(Organization (ePI))	The organization responsible for the particular process, e.g. the manufacturer or importer	Σ	0..*	Reference(Organization)	The organization responsible for the particular process, e.g. the manufacturer or importer
confidentialityIndicator	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.	Σ	0..1	CodeableConcept	Specifies whether this process is considered proprietary or confidential Binding: ?? (example): Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
characteristic	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"	Σ	0..*	BackboneElement	Key product features such as "sugar free", "modified release"
id		0..1	string	Unique id for inter-element referencing		0..1	string	Unique id for inter-element referencing
extension		0..*	Extension	Additional content defined by implementations		0..*	Extension	Additional content defined by implementations	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.' vs 'May be used to represent additional information that is not part of the basic definition of the element. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.'
modifierExtension	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	?!Σ	0..*	Extension	Extensions that cannot be ignored even if unrecognized	Elements differ in definition: 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).' vs 'May be used to represent additional information that is not part of the basic definition of the element and that modifies the understanding of the element in which it is contained and/or the understanding of the containing element's descendants. Usually modifier elements provide negation or qualification. To make the use of extensions safe and managable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer can define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension. Applications processing a resource are required to check for modifier extensions. Modifier extensions SHALL NOT change the meaning of any elements on Resource or DomainResource (including cannot change the meaning of modifierExtension itself).'
type	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.	Σ	1..1	CodeableConcept	A code expressing the type of characteristic Binding: ?? (example): This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
value[x]	Σ	0..1	CodeableConcept, string, Quantity, integer, date, boolean, Attachment	A value for the characteristic	Σ	0..1	CodeableConcept, markdown, Quantity, integer, date, boolean, Attachment	A value for the characteristic	Elements differ in comments: 'String is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept. (temporary text to make build work: The usage of CodeableConcept is for concepts that are normally coded but for which a code is not available - for example a device implant size that is not standardized. The property string is for text characteristics, e.g. long descriptions, warnings, etc.).' vs 'Text, as markdown, is intended to be used only when the item cannot ever reasonably be coded. Otherwise, for cases where a code is not available, but is feasible, use CodeableConcept.text.'
Documentation for this format