Generated Narrative: StructureDefinition ch-idmp-medicinalproductdefinition Name Flags Card. Type Description & Constraints MedicinalProductDefinition 0..* MedicinalProductDefinition CH IDMP MedicinalProductDefinition #xD; Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url #xD; extension:authorizedDoseForm 0..1 CodeableConcept CH - SMC Authorized Dose Form URL: http://fhir.ch/ig/ch-epl/StructureDefinition/authorizedDoseForm Binding: CH SMC - Authorised Pharmaceutical Dose Form (required) #xD; extension:fullLimitationText 0..1 string CH - EPL Full Limitation Text URL: http://fhir.ch/ig/ch-epl/StructureDefinition/fullLimitationText #xD; identifier #xD; system 1..1 uri The namespace for the identifier value Required Pattern: http://fhir.ch/ig/ch-epl/sid/mpid #xD; value 1..1 string The value that is unique #xD; combinedPharmaceuticalDoseForm 0..1 CodeableConcept The dose form for a single part product, or combined form of a multiple part product Binding: EDQM - Combined Pharmaceutical Dose Form (required) #xD; Slices for coding 0..* Coding Code defined by a terminology system Slice: Unordered, Open by value:system #xD; coding:EDQM 0..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://standardterms.edqm.eu #xD; code 1..1 code Symbol in syntax defined by the system #xD; indication 0..1 markdown Description of indication(s) for this product #xD; additionalMonitoringIndicator 0..1 CodeableConcept Whether the Medicinal Product is subject to additional monitoring for regulatory reasons Binding: CH SMC - Additional Monitoring Indicator (required) #xD; Slices for coding 0..1 Coding Code defined by a terminology system Slice: Unordered, Open by value:system #xD; coding:SMC 0..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-additional-monitoring-indicator #xD; code 1..1 code Symbol in syntax defined by the system #xD; pediatricUseIndicator 0..1 CodeableConcept If authorised for use in children Binding: CH SMC - Pediatric Use Indicator (required) #xD; Slices for coding 0..1 Coding Code defined by a terminology system Slice: Unordered, Open by value:system #xD; coding:SMC 0..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-pediatric-use-indicator #xD; code 1..1 code Symbol in syntax defined by the system #xD; Slices for classification 0..* CodeableConcept Allows the product to be classified by various systems Slice: Unordered, Open by value:coding.system #xD; classification:ATC 0..1 CodeableConcept Allows the product to be classified by various systems #xD; coding 1..* Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://www.whocc.no/atc #xD; code 1..1 code Symbol in syntax defined by the system #xD; classification:AuthorisationCategory 0..1 CodeableConcept Allows the product to be classified by various systems #xD; coding 1..* Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-category #xD; code 1..1 code Symbol in syntax defined by the system #xD; classification:TherapeuticProductcode 0..1 CodeableConcept Allows the product to be classified by various systems #xD; coding 1..* Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-therapeuticproductcode #xD; code 1..1 code Symbol in syntax defined by the system #xD; classification:ProductType 0..1 CodeableConcept Allows the product to be classified by various systems #xD; coding 1..* Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-product-type #xD; code 1..1 code Symbol in syntax defined by the system #xD; classification:ITC 0..1 CodeableConcept Allows the product to be classified by various systems #xD; coding 1..* Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Fixed Value: http://fhir.ch/ig/ch-epl/CodeSystem/ch-epl-foph-index-therapeuticus #xD; code 1..1 code Symbol in syntax defined by the system #xD; marketingStatus #xD; country 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 Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:3166 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: CH #xD; status #xD; Slices for coding 0..1 Coding Code defined by a terminology system Slice: Unordered, Open by value:system #xD; coding:SMC 0..1 Coding Code defined by a terminology system #xD; system 1..1 uri Identity of the terminology system Required Pattern: http://fhir.ch/ig/ch-epl/CodeSystem/ch-SMC-marketing-status #xD; attachedDocument 0..* Reference(CH IDMP DocumentReference) Professional information and/or patient information #xD; Slices for name 1..* BackboneElement The product's name, including full name and possibly coded parts Slice: Unordered, Open by value:usage.language #xD; name:en 0..1 BackboneElement The product's name, including full name and possibly coded parts #xD; productName 1..1 string The full product name in English #xD; part #xD; type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (required) #xD; usage #xD; country 1..1 CodeableConcept Country code for where this name applies Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:3166 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: CH #xD; language 1..1 CodeableConcept Language code for this name Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:ietf:bcp:47 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: en #xD; name:de-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts #xD; productName 1..1 string The full product name in German (Switzerland) #xD; part #xD; type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (required) #xD; usage #xD; country 1..1 CodeableConcept Country code for where this name applies Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:3166 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: CH #xD; language 1..1 CodeableConcept Language code for this name Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:ietf:bcp:47 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: de-CH #xD; name:fr-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts #xD; productName 1..1 string The full product name in French (Switzerland) #xD; part #xD; type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (required) #xD; usage #xD; country 1..1 CodeableConcept Country code for where this name applies Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:3166 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: CH #xD; language 1..1 CodeableConcept Language code for this name Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:ietf:bcp:47 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: fr-CH #xD; name:it-CH 0..1 BackboneElement The product's name, including full name and possibly coded parts #xD; productName 1..1 string The full product name in Italian (Switzerland) #xD; part #xD; type 1..1 CodeableConcept Identifying type for this part of the name (e.g. strength part) Binding: ProductNamePartType (required) #xD; usage #xD; country 1..1 CodeableConcept Country code for where this name applies Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:iso:std:iso:3166 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: CH #xD; language 1..1 CodeableConcept Language code for this name Required Pattern: At least the following #xD; coding 1..* Coding Code defined by a terminology system Fixed Value: (Complex) #xD; system 1..1 uri Identity of the terminology system Fixed Value: urn:ietf:bcp:47 #xD; code 1..1 code Symbol in syntax defined by the system Fixed Value: it-CH #xD; Documentation for this format
Profile of the MedicinalProductDefinition resource for representing the detailed data of medicinal products.
A medicinal product, being a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. This resource is intended to define and detail such products and their properties, for uses other than direct patient care (e.g. regulatory use, or drug catalogs).
If the resource is contained in another resource, it SHALL NOT contain nested Resources
If the resource is contained in another resource, it SHALL be referred to from elsewhere in the resource or SHALL refer to the containing resource
contained.where((('#'+id in (%resource.descendants().reference | %resource.descendants().ofType(canonical) | %resource.descendants().ofType(uri) | %resource.descendants().ofType(url))) or descendants().where(reference = '#').exists() or descendants().where(ofType(canonical) = '#').exists() or descendants().where(ofType(canonical) = '#').exists()).not()).trace('unmatched', id).empty()
If a resource is contained in another resource, it SHALL NOT have a meta.versionId or a meta.lastUpdated
contained.meta.versionId.empty() and contained.meta.lastUpdated.empty()
If a resource is contained in another resource, it SHALL NOT have a security label
When a resource has no narrative, only systems that fully understand the data can display the resource to a human safely. Including a human readable representation in the resource makes for a much more robust eco-system and cheaper handling of resources by intermediary systems. Some ecosystems restrict distribution of resources to only those systems that do fully understand the resources, and as a consequence implementers may believe that the narrative is superfluous. However experience shows that such eco-systems often open up to new participants over time.
A resource should have narrative for robust management
Entity, Role, or Act,ManufacturedProduct[classCode='MANU'].manufacturedProduct[classCode='MMAT']
Medicinal Product and Investigational Medicinal Product
The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes.
Within the context of the FHIR RESTful interactions, the resource has an id except for cases like the create and conditional update. Otherwise, the use of the resouce id depends on the given use case.
The metadata about the resource. This is content that is maintained by the infrastructure. Changes to the content might not always be associated with version changes to the resource.
All FHIR elements must have a @value or children
hasValue() or (children().count() > id.count())
A set of rules under which this content was created
A reference to a set of rules that were followed when the resource was constructed, and which must be understood when processing the content. Often, this is a reference to an implementation guide that defines the special rules along with other profiles etc.
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.
This element is labeled as a modifier because the implicit rules may provide additional knowledge about the resource that modifies its meaning or interpretation
The base language in which the resource is written.
Language is provided to support indexing and accessibility (typically, services such as text to speech use the language tag). The html language tag in the narrative applies to the narrative. The language tag on the resource may be used to specify the language of other presentations generated from the data in the resource. Not all the content has to be in the base language. The Resource.language should not be assumed to apply to the narrative automatically. If a language is specified, it should it also be specified on the div element in the html (see rules in HTML5 for information about the relationship between xml:lang and the html lang attribute).
Text summary of the resource, for human interpretation
A human-readable narrative that contains a summary of the resource and can be used to represent the content of the resource to a human. The narrative need not encode all the structured data, but is required to contain sufficient detail to make it "clinically safe" for a human to just read the narrative. Resource definitions may define what content should be represented in the narrative to ensure clinical safety.
Contained resources do not have a narrative. Resources that are not contained SHOULD have a narrative. In some cases, a resource may only have text with little or no additional discrete data (as long as all minOccurs=1 elements are satisfied). This may be necessary for data from legacy systems where information is captured as a "text blob" or where text is additionally entered raw or narrated and encoded information is added later.
These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, nor can they have their own independent transaction scope. This is allowed to be a Parameters resource if and only if it is referenced by a resource that provides context/meaning.
This should never be done when the content can be identified properly, as once identification is lost, it is extremely difficult (and context dependent) to restore it again. Contained resources may have profiles and tags in their meta elements, but SHALL NOT have security labels.
Must have either extensions or value[x], not both
Extension for representing the authorized dose form
Extension for representing the full wording of the limitations used by FOPH
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).
There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.
Modifier extensions allow for extensions that *cannot* be safely ignored to be clearly distinguished from the vast majority of extensions which can be safely ignored. This promotes interoperability by eliminating the need for implementers to prohibit the presence of extensions. For further information, see the [definition of modifier extensions](http://hl7.org/fhir/R5/extensibility.html#modifierExtension).
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Business identifier for this product. Could be an MPID
Business identifier for this product. Could be an MPID. When in development or being regulated, products are typically referenced by official identifiers, assigned by a manufacturer or regulator, and unique to a product (which, when compared to a product instance being prescribed, is actually a product type). See also MedicinalProductDefinition.code.
Medicinal Product.MPID, Investigational Medicinal Product.IMPID
Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
Extensions are always sliced by (at least) url
Additional content defined by implementations
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.
usual | official | temp | secondary | old (If known)
Applications can assume that an identifier is permanent unless it explicitly says that it is temporary.
Allows the appropriate identifier for a particular context of use to be selected from among a set of identifiers.
This is labeled as "Is Modifier" because applications should not mistake a temporary id for a permanent one.
Identifies the purpose for this identifier, if known .
A coded type for the identifier that can be used to determine which identifier to use for a specific purpose.
This element deals only with general categories of identifiers. It SHOULD not be used for codes that correspond 1..1 with the Identifier.system. Some identifiers may fall into multiple categories due to common usage. Where the system is known, a type is unnecessary because the type is always part of the system definition. However systems often need to handle identifiers where the system is not known. There is not a 1:1 relationship between type and system, since many different systems have the same type.
Allows users to make use of identifiers when the identifier system is not known.
A coded type for an identifier that can be used to determine which identifier to use for a specific purpose.
Establishes the namespace for the value - that is, an absolute URL that describes a set values that are unique.
Identifier.system is always case sensitive.
There are many sets of identifiers. To perform matching of two identifiers, we need to know what set we're dealing with. The system identifies a particular set of unique identifiers.
The portion of the identifier typically relevant to the user and which is unique within the context of the system.
If the value is a full URI, then the system SHALL be urn:ietf:rfc:3986. The value's primary purpose is computational mapping. As a result, it may be normalized for comparison purposes (e.g. removing non-significant whitespace, dashes, etc.) A value formatted for human display can be conveyed using the [http://hl7.org/fhir/StructureDefinition/rendered-value](http://hl7.org/fhir/extensions/StructureDefinition-rendered-value.html)). Identifier.value is to be treated as case sensitive unless knowledge of the Identifier.system allows the processer to be confident that non-case-sensitive processing is safe.
II.extension or II.root if system indicates OID or GUID (Or Role.id.extension or root)
Time period when id is/was valid for use
Time period during which identifier is/was valid for use.
Role.effectiveTime or implied by context
Organization that issued id (may be just text)
Organization that issued/manages the identifier.
The Identifier.assigner may omit the .reference element and only contain a .display element reflecting the name or other textual information about the assigning organization.
II.assigningAuthorityName but note that this is an improper use by the definition of the field. Also Role.scoper
Regulatory type, e.g. Investigational or Authorized
Regulatory type, e.g. Investigational or Authorized.
Overall defining type of this medicinal product.
(indicates if this is Medicinal Product or an Investigational Medicinal Product)
If this medicine applies to human or veterinary uses
If this medicine applies to human or veterinary uses.
Applicable domain for this product (e.g. human, veterinary).
A business identifier relating to a specific version of the product
A business identifier relating to a specific version of the product, this is commonly used to support revisions to an existing product.
The status within the lifecycle of this product record
The status within the lifecycle of this product record. A high-level status, this is not intended to duplicate details carried elsewhere such as legal status, or authorization status.
This element is labelled as a modifier because it is a status element that can indicate that a record should not be treated as valid
The date at which the given status became applicable
The date at which the given status became applicable.
The dose form for a single part product, or combined form of a multiple part product
The dose form for a single part product, or combined form of a multiple part product. This is one concept that describes all the components. It does not represent the form with components physically mixed, if that might be necessary, for which see (AdministrableProductDefinition.administrableDoseForm).
Medicinal Product.Combined Pharmaceutical Dose Form
A reference to a code defined by a terminology system.
Codes may be defined very casually in enumerations, or code lists, up to very formal definitions such as SNOMED CT - see the HL7 v3 Core Principles for more information. Ordering of codings is undefined and SHALL NOT be used to infer meaning. Generally, at most only one of the coding values will be labeled as UserSelected = true.
Allows for alternative encodings within a code system, and translations to other code systems.
fhir:CodeableConcept.coding rdfs:subPropertyOf dt:CD.coding
The identification of the code system that defines the meaning of the symbol in the code.
The URI may be an OID (urn:oid:...) or a UUID (urn:uuid:...). OIDs and UUIDs SHALL be references to the HL7 OID registry. Otherwise, the URI should come from HL7's list of FHIR defined special URIs or it should be an absolute reference to some definition that establishes the system clearly and unambiguously.
Need to be unambiguous about the source of the definition of the symbol.
fhir:Coding.system rdfs:subPropertyOf dt:CDCoding.codeSystem
The version of the code system which was used when choosing this code. Note that a well-maintained code system does not need the version reported, because the meaning of codes is consistent across versions. However this cannot consistently be assured, and when the meaning is not guaranteed to be consistent, the version SHOULD be exchanged.
Where the terminology does not clearly define what string should be used to identify code system versions, the recommendation is to use the date (expressed in FHIR date format) on which that version was officially published as the version date.
fhir:Coding.version rdfs:subPropertyOf dt:CDCoding.codeSystemVersion
A symbol in syntax defined by the system. The symbol may be a predefined code or an expression in a syntax defined by the coding system (e.g. post-coordination).
Need to refer to a particular code in the system.
fhir:Coding.code rdfs:subPropertyOf dt:CDCoding.code
A representation of the meaning of the code in the system, following the rules of the system.
Need to be able to carry a human-readable meaning of the code for readers that do not know the system.
C*E.2 - but note this is not well followed
fhir:Coding.display rdfs:subPropertyOf dt:CDCoding.displayName
If this coding was chosen directly by the user
Indicates that this coding was chosen by a user directly - e.g. off a pick list of available items (codes or displays).
Amongst a set of alternatives, a directly chosen code is the most appropriate starting point for new translations. There is some ambiguity about what exactly 'directly chosen' implies, and trading partner agreement may be needed to clarify the use of this element and its consequences more completely.
This has been identified as a clinical safety criterium - that this exact system/code pair was chosen explicitly, rather than inferred by the system based on some rules or language processing.
fhir:Coding.userSelected fhir:mapsTo dt:CDCoding.codingRationale. fhir:Coding.userSelected fhir:hasMap fhir:Coding.userSelected.map. fhir:Coding.userSelected.map a fhir:Map; fhir:target dt:CDCoding.codingRationale. fhir:Coding.userSelected\#true a [ fhir:source "true"; fhir:target dt:CDCoding.codingRationale\#O ]
Plain text representation of the concept
A human language representation of the concept as seen/selected/uttered by the user who entered the data and/or which represents the intended meaning of the user.
Very often the text is the same as a displayName of one of the codings.
The codes from the terminologies do not always capture the correct meaning with all the nuances of the human using them, or sometimes there is no appropriate code at all. In these cases, the text is used to capture the full meaning of the source.
C*E.9. But note many systems use C*E.2 for this
fhir:CodeableConcept.text rdfs:subPropertyOf dt:CD.originalText
The path by which the product is taken into or makes contact with the body
The path by which the product is taken into or makes contact with the body. In some regions this is referred to as the licenced or approved route. See also AdministrableProductDefinition resource. MedicinalProductDefinition.route is the same concept as AdministrableProductDefinition.routeOfAdministration.code, and they cannot be used together.
A code specifying the route or physiological path of administration of a therapeutic agent into or onto a patient's body.
Pharmaceutical Product.Route of Administration
Description of indication(s) for this product
Description of indication(s) for this product, used when structured indications are not required. In cases where structured indications are required, they are captured using the ClinicalUseDefinition resource. An indication is a medical situation for which using the product is appropriate.
(roll up of all text in Therapeutic Indication.Indication Text, for common case where information is not granular)
The legal status of supply of the medicinal product as classified by the regulator
The legal status of supply of the medicinal product as classified by the regulator.
The prescription supply types appropriate to a medicinal product
Marketing Authorisation.Legal Status of Supply (moved here for practicality)
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons
Whether the Medicinal Product is subject to additional monitoring for regulatory reasons, such as heightened reporting requirements.
Medicinal Product.Additional Monitoring Indicator
Whether the Medicinal Product is subject to special measures for regulatory reasons
Whether the Medicinal Product is subject to special measures for regulatory reasons, such as a requirement to conduct post-authorization studies.
Extra measures defined for a Medicinal Product, such as a requirement to conduct post-authorization studies.
If authorised for use in children, or infants, neonates etc.
Medicinal Product.Pediatric Use Indicator
Allows the product to be classified by various systems
Allows the product to be classified by various systems, commonly WHO ATC.
This value set includes codes from the Anatomical Therapeutic Chemical Classification System - provided as an exemplar value set.
Marketing status of the medicinal product, in contrast to marketing authorization
Marketing status of the medicinal product, in contrast to marketing authorization. This refers to the product being actually 'on the market' as opposed to being allowed to be on the market (which is an authorization).
Extensions that cannot be ignored even if unrecognized
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).
Modifier extensions are expected to modify the meaning or interpretation of the element that contains them
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
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.
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
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.
This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples
This attribute provides information on the status of the marketing of the medicinal product See ISO/TS 20443 for more information and examples.
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
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.
Package type for the product. See also the PackagedProductDefinition resource.
Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes
Types of medicinal manufactured items and/or devices that this product consists of, such as tablets, capsule, or syringes. Used as a direct link when the item's packaging is not being recorded (see also PackagedProductDefinition.package.containedItem.item).
The ingredients of this medicinal product - when not detailed in other resources
The ingredients of this medicinal product - when not detailed in other resources. This is only needed if the ingredients are not specified by incoming references from the Ingredient resource, or indirectly via incoming AdministrableProductDefinition, PackagedProductDefinition or ManufacturedItemDefinition references. In cases where those levels of detail are not used, the ingredients may be specified directly here as codes.
This value set includes all substance codes from SNOMED CT - provided as an exemplar value set.
Medicinal Product.Ingredient (see also FHIR Ingredient resource)
Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product
Any component of the drug product which is not the chemical entity defined as the drug substance, or an excipient in the drug product. This includes process-related impurities and contaminants, product-related impurities including degradation products.
Professional information and/or patient information
Additional information or supporting documentation about the medicinal product.
A master file for the medicinal product (e.g. Pharmacovigilance System Master File)
A master file for the medicinal product (e.g. Pharmacovigilance System Master File). Drug master files (DMFs) are documents submitted to regulatory agencies to provide confidential detailed information about facilities, processes or articles used in the manufacturing, processing, packaging and storing of drug products.
A product specific contact, person (in a role), or an organization
A product specific contact, person (in a role), or an organization.
Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information
Allows the contact to be classified, for example QPPV, Pharmacovigilance Enquiry Information.
Extra measures defined for a Medicinal Product, such as heightened reporting requirements.
Clinical trials or studies that this product is involved in
Clinical trials or studies that this product is involved in.
Investigational Medicinal Product.Clinical Trial Status
A code that this product is known by, within some formal terminology
A code that this product is known by, usually within some formal terminology, perhaps assigned by a third party (i.e. not the manufacturer or regulator). Products (types of medications) tend to be known by identifiers during development and within regulatory process. However when they are prescribed they tend to be identified by codes. The same product may be have multiple codes, applied to it by multiple organizations.
A coded concept that defines the type of a medication.
The product's name, including full name and possibly coded parts
The product's name, including full name and possibly coded parts.
Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary
Type of product name, such as rINN, BAN, Proprietary, Non-Proprietary.
(any and all of the name parts e.g. Medicinal Product Name.Formulation Part)
(text of any of the name parts e.g. Medicinal Product Name.Formulation Part)
Identifying type for this part of the name (e.g. strength part)
Identifying type for this part of the name (e.g. strength part).
Type of part of a name for a Medicinal Product.
(which of the name parts this is e.g. Formulation Part)
Country and jurisdiction where the name applies
Country and jurisdiction where the name applies, and associated language.
Country code for where this name applies
Country code for where this name applies.
Jurisdiction code for where this name applies
Jurisdiction code for where this name applies. A jurisdiction may be a sub- or supra-national entity (e.g. a state or a geographic region).
The full product name in German (Switzerland)
The full product name in French (Switzerland)
The full product name in Italian (Switzerland)
Reference to another product, e.g. for linking authorised to investigational product
Reference to another product, e.g. for linking authorised to investigational product, or a virtual product.
Reference to another product, e.g. for linking authorised to investigational product.
The type of relationship, for instance branded to generic or virtual to actual product
The type of relationship, for instance branded to generic, virtual to actual product, product to development product (investigational), parallel import version.
A manufacturing or administrative process for the medicinal product
A manufacturing or administrative process or step associated with (or performed on) the medicinal product.
The type of manufacturing operation e.g. manufacturing itself, re-packaging
The type of manufacturing operation e.g. manufacturing itself, re-packaging. For the authorization of this, a RegulatedAuthorization would point to the same plan or activity referenced here.
Manufacturing / Business Operation.Operation Type
Manufacturing / Business Operation.Effective Date
The organization responsible for the particular process, e.g. the manufacturer or importer
The organization or establishment responsible for (or associated with) the particular process or step, examples include the manufacturer, importer, agent.
Manufacturer / Establishment (Organisation)
Specifies whether this process is considered proprietary or confidential
Specifies whether this particular business or manufacturing process is considered proprietary or confidential.
Confidentiality rating, e.g. commercial sensitivity for a Medicinal Product.
Manufacturing / Business Operation.Confidentiality Indicator
Key product features such as "sugar free", "modified release"
Allows the key product features to be recorded, such as "sugar free", "modified release", "parallel import".
Package Item (Container).Physical Characteristics
A code expressing the type of characteristic
A code expressing the type of characteristic.
This value set includes all observable entity codes from SNOMED CT - provided as an exemplar value set.
Physical Characteristics, all attributes
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.
Physical Characteristics, attribute's value