Generated Narrative: StructureDefinition emaWriteApiRegulatedAuthorization Name Flags Card. Type Description & Constraints<img src="[binary]" alt="doco" style="background-color: inherit"/> RegulatedAuthorization <a style="padding-left: 3px; padding-right: 3px; border: 1px maroon solid; font-weight: bold; color: #301212; background-color: #fdf4f4;" href="http://hl7.org/fhir/R5/conformance-rules.html#constraints" title="This element has or is affected by constraints ( regulatorIsMandatoryIfManufacturingIdentifierExists, validityPeriodIsMandatoryIfManufacturingIdentifierExists, regionIsEmptyForManAuth, statusDateIsEmptyForManAuth, holderIsEmptyForManAuth, caseIsEmptyForManAuth, extensionIsEmptyForManAuth, manAuthNumberIsMandatoryForCertainManufacturingActivities, marketingAuthorizationNumberIsMandatoryForMarktAuth, validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd, dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd, internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd, caseIsMandatoryForMarktAuthIfSubjectIsMpd, holderIsMandatoryForMarktAuthIfSubjectIsMpd )">C 0..* EmaWriteApiRegulatedAuthorizationRestrictions Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product regulatorIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the regulator is mandatory validityPeriodIsMandatoryIfManufacturingIdentifierExists: If there is a Manufacturing Identifier, then the validity period is mandatory regionIsEmptyForManAuth: The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization. statusDateIsEmptyForManAuth: The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization. holderIsEmptyForManAuth: The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization. caseIsEmptyForManAuth: The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization. extensionIsEmptyForManAuth: The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization. manAuthNumberIsMandatoryForCertainManufacturingActivities: The RegulatedAuthorization's Manufacturing Authorization Number identifier is mandatory when the subject references an ActivityDefinition whose code is among the following ones: 100000163737, 100000163709, 100000163618, 100000160477, 100000160476, 100000160464, 100000160463, 100000160462, 100000160461, 100000160460, 100000160459, 100000160458, 100000160457, 100000160456, 100000160414, 100000160413, 100000160412, 100000160411, 100000160410, 100000160409, 100000160408, 100000160407. marketingAuthorizationNumberIsMandatoryForMarktAuth: The RegulatedAuthorization must have the Marketing Authorization Number identifier. validityPeriodIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition. dateOfFirstAuthorisationIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the Date of First Authorisation extension. internationalBirthDateIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have the International Birth Date extension. caseIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition. holderIsMandatoryForMarktAuthIfSubjectIsMpd: The RegulatedAuthorization must have a holder. Slices for extension 0..* Extension Extension Slice: Unordered, Open by value:url extension:dateOfFirstAuthorisation 0..1 date Regulated Authorization - Date of First Authorisation URL: http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation extension:internationalBirthDate 0..1 date Regulated Authorization - International Birth Date URL: http://ema.europa.eu/fhir/extension/internationalBirthDate Slices for identifier 0..2 Identifier Business identifier for the authorization, typically assigned by the authorizing body Slice: Unordered, Open by value:system identifier:marketingAuthorizationIdentifier 0..1 EmaMarketingAuthorizationIdentifier Business identifier for the authorization, typically assigned by the authorizing body system 1..1 uri The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/MarketingAuthorizationNumber identifier:manufacturingAuthorizationNumberIdentifier 0..1 EmaManufacturingAuthNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body system 1..1 uri The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/manufacturingAuthorizationNumber identifier:eudraGmpNumberIdentifier 0..1 EmaEudraGmpNumberIdentifier Business identifier for the authorization, typically assigned by the authorizing body system 1..1 uri The namespace for the identifier value Required Pattern: http://ema.europa.eu/fhir/eudraGmpNumber subject 1..1 Reference(EMA Write API MedicinalProductDefinition | EMA Write API PackagedProductDefinition | EMA Write API ActivityDefinition) The product type, treatment, facility or activity that is being authorized type 1..1 EmaRefTermCodeableConcept Overall type of this authorization, for example drug marketing approval, orphan drug designation Binding: Regulatory Entitlement Type (required) coding 1..1 EmaCoding Code defined by a terminology system Binding: Marketing and Manufacturing types (required) status 1..1 EmaRefTermCodeableConcept The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications Binding: Regulatory Entitlement Status (required) holder identifier 1..1 Identifier Logical reference, when literal reference is not known system 1..1 uri The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/locations value 1..1 string The value that is unique regulator identifier system 1..1 uri The namespace for the identifier value Required Pattern: http://spor.ema.europa.eu/v1/locations value 1..1 string The value that is unique case Slices for date[x] 0..1 Period, dateTime Relevant date for this case Slice: Unordered, Open by type:$this date[x]:datePeriod 0..1 Period Relevant date for this case application 0..1 BackboneElement Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure identifier 0..1 EmaApplicationIdentifierNumber Identifier by which this case can be referenced type 0..1 CodeableConcept The defining type of case Binding: Application Submission Type (required) Slices for date[x] 1..1 dateTime Relevant date for this case Slice: Unordered, Open by type:$this date[x]:dateDateTime 1..1 dateTime Relevant date for this case <img src="[binary]" alt="doco" style="background-color: inherit"/> Documentation for this format
Defines the rules a Marketing or Manufacturing RegulatedAuthorization resource instance must conform to when belonging to a FHIR bundle representing a Human Variation Application
Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity e.g. Market Authorization for a Medicinal Product
Regulatory approval, clearance or licencing related to a regulated product, treatment, facility or activity that is cited in a guidance, regulation, rule or legislative act. An example is Market Authorization relating to a Medicinal Product.
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
If there is a Manufacturing Identifier, then the regulator is mandatory
(type.coding.code = '200000051585' and identifier.exists()) implies regulator.exists()
If there is a Manufacturing Identifier, then the validity period is mandatory
(type.coding.code = '200000051585' and identifier.exists()) implies validityPeriod.exists()
The RegulatedAuthorization must not have a Region if it is a Manufacturing Authorization.
(type.coding.exists(code = '200000051585')) implies (region.empty())
The RegulatedAuthorization must not have a StatusDate if it is a Manufacturing Authorization.
(type.coding.exists(code = '200000051585')) implies (statusDate.empty())
The RegulatedAuthorization must not have a Holder if it is a Manufacturing Authorization.
(type.coding.exists(code = '200000051585')) implies (holder.empty())
The RegulatedAuthorization must not have a Case if it is a Manufacturing Authorization.
(type.coding.exists(code = '200000051585')) implies (case.empty())
The RegulatedAuthorization must not have an Extension if it is a Manufacturing Authorization.
(type.coding.exists(code = '200000051585')) implies (extension.empty())
The RegulatedAuthorization must have the Marketing Authorization Number identifier.
(type.coding.exists(code = '220000000061')) implies identifier.where(system = 'http://ema.europa.eu/fhir/MarketingAuthorizationNumber').exists()
The RegulatedAuthorization must have a validityPeriod if the subject is a MedicinalProductDefinition.
subject.reference.startsWith('MedicinalProductDefinition/') implies validityPeriod.exists()
The RegulatedAuthorization must have the Date of First Authorisation extension.
subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/dateOfFirstAuthorisation').exists()
The RegulatedAuthorization must have the International Birth Date extension.
subject.reference.startsWith('MedicinalProductDefinition/') implies extension.where(url = 'http://ema.europa.eu/fhir/extension/internationalBirthDate').exists()
The RegulatedAuthorization must have a case if the subject is a Medicinal Product Definition.
subject.reference.startsWith('MedicinalProductDefinition/') implies case.exists()
The RegulatedAuthorization must have a holder.
subject.reference.startsWith('MedicinalProductDefinition/') implies holder.exists()
Marketing Authorization, Clinical Trial Authorization
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
Regulated Authorization - Date of First Authorisation
The Regulated Authorization's Date of First Authorisation
Regulated Authorization - International Birth Date
The Regulated Authorization's International Birth Date
Modifier extensions are expected to modify the meaning or interpretation of the resource that contains them
Slice based on the system of the identifier
Business identifier for the authorization, typically assigned by the authorizing body
Business identifier for the authorization, typically assigned by the authorizing body.
Marketing Authorization.Marketing Authorization Number
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
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
The product type, treatment, facility or activity that is being authorized
The product type, treatment, facility or activity that is being authorized.
(the link to Medicinal Product or Packaged Medicinal Product)
Overall type of this authorization, for example drug marketing approval, orphan drug designation
Overall type of this authorization, for example drug marketing approval, orphan drug designation.
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
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 territory in which the authorization has been granted
The territory (e.g., country, jurisdiction etc.) in which the authorization has been granted.
The status that is authorised e.g. approved. Intermediate states can be tracked with cases and applications
The status that is authorised e.g. approved. Intermediate states and actions can be tracked with cases and applications.
Marketing Authorization.Authorization Status
The date at which the current status was assigned
The date at which the current status was assigned.
Marketing Authorization.Authorization Status Date
The time period in which the regulatory approval etc. is in effect, e.g. a Marketing Authorization includes the date of authorization and/or expiration date
The time period in which the regulatory approval, clearance or licencing is in effect. As an example, a Marketing Authorization includes the date of authorization and/or an expiration date.
Marketing Authorization.Validity Period Start, Marketing Authorization.Validity Period End
Condition for which the use of the regulated product applies
Condition for which the use of the regulated product applies.
The intended use of the product, e.g. prevention, treatment
The intended use of the product, e.g. prevention, treatment, diagnosis.
The legal/regulatory framework or reasons under which this authorization is granted
The legal or regulatory framework against which this authorization is granted, or other reasons for it.
A legal or regulatory framework against which an authorization is granted, or other reasons for it.
Marketing Authorization.Status Reasons.Legal Grounds
The organization that has been granted this authorization, by the regulator
The organization that has been granted this authorization, by some authoritative body (the 'regulator').
Marketing Authorization.Marketing Authorization Holder (Organisation)
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.
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.
Literal reference, Relative, internal or absolute URL
A reference to a location at which the other resource is found. The reference may be a relative reference, in which case it is relative to the service base URL, or an absolute URL that resolves to the location where the resource is found. The reference may be version specific or not. If the reference is not to a FHIR RESTful server, then it should be assumed to be version specific. Internal fragment references (start with '#') refer to contained resources.
Using absolute URLs provides a stable scalable approach suitable for a cloud/web context, while using relative/logical references provides a flexible approach suitable for use when trading across closed eco-system boundaries. Absolute URLs do not need to point to a FHIR RESTful server, though this is the preferred approach. If the URL conforms to the structure "[type]/[id]" then it should be assumed that the reference is to a FHIR RESTful server.
Type the reference refers to (e.g. "Patient") - must be a resource in resources
The expected type of the target of the reference. If both Reference.type and Reference.reference are populated and Reference.reference is a FHIR URL, both SHALL be consistent. The type is the Canonical URL of Resource Definition that is the type this reference refers to. References are URLs that are relative to http://hl7.org/fhir/StructureDefinition/ e.g. "Patient" is a reference to http://hl7.org/fhir/StructureDefinition/Patient. Absolute URLs are only allowed for logical models (and can only be used in references in logical models, not resources).
This element is used to indicate the type of the target of the reference. This may be used which ever of the other elements are populated (or not). In some cases, the type of the target may be determined by inspection of the reference (e.g. a known RESTful URL) or by resolving the target of the reference.
Aa resource (or, for logical models, the URI of the logical model).
Logical reference, when literal reference is not known
An identifier for the target resource. This is used when there is no way to reference the other resource directly, either because the entity it represents is not available through a FHIR server, or because there is no way for the author of the resource to convert a known identifier to an actual location. There is no requirement that a Reference.identifier point to something that is actually exposed as a FHIR instance, but it SHALL point to a business concept that would be expected to be exposed as a FHIR instance, and that instance would need to be of a FHIR resource type allowed by the reference.
When an identifier is provided in place of a reference, any system processing the reference will only be able to resolve the identifier to a reference if it understands the business context in which the identifier is used. Sometimes this is global (e.g. a national identifier) but often it is not. For this reason, none of the useful mechanisms described for working with references (e.g. chaining, includes) are possible, nor should servers be expected to be able resolve the reference. Servers may accept an identifier based reference untouched, resolve it, and/or reject it - see CapabilityStatement.rest.resource.referencePolicy. When both an identifier and a literal reference are provided, the literal reference is preferred. Applications processing the resource are allowed - but not required - to check that the identifier matches the literal reference Applications converting a logical reference to a literal reference may choose to leave the logical reference present, or remove it. Reference is intended to point to a structure that can potentially be expressed as a FHIR resource, though there is no need for it to exist as an actual FHIR resource instance - except in as much as an application wishes to actual find the target of the reference. The content referred to be the identifier must meet the logical constraints implied by any limitations on what resource types are permitted for the reference. For example, it would not be legitimate to send the identifier for a drug prescription if the type were Reference(Observation|DiagnosticReport). One of the use-cases for Reference.identifier is the situation where no FHIR representation exists (where the type is Reference (Any). This element only allows for a single identifier. In the case where additional identifers are required, use the [http://hl7.org/fhir/StructureDefinition/additionalIdentifier](http://hl7.org/fhir/extensions/StructureDefinition-additionalIdentifier.html) extension.
Plain text narrative that identifies the resource in addition to the resource reference.
This is generally not the same as the Resource.text of the referenced resource. The purpose is to identify what's being referenced, not to fully describe it.
The regulatory authority or authorizing body granting the authorization
The regulatory authority or authorizing body granting the authorization. For example, European Medicines Agency (EMA), Food and Drug Administration (FDA), Health Canada (HC), etc.
Marketing Authorization.Medicines Regulatory Agency (Organisation)
Additional information or supporting documentation about the authorization
Additional information or supporting documentation about the authorization.
The case or regulatory procedure for granting or amending a regulated authorization. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page)
The case or regulatory procedure for granting or amending a regulated authorization. An authorization is granted in response to submissions/applications by those seeking authorization. A case is the administrative process that deals with the application(s) that relate to this and assesses them. Note: This area is subject to ongoing review and the workgroup is seeking implementer feedback on its use (see link at bottom of page).
Marketing Authorization.Marketing Authorization Procedure, Marketing Authorization Procedure.Marketing Authorization Application
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 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 element that contains them
Identifier by which this case can be referenced
Identifier by which this case can be referenced.
Marketing Authorization Procedure.Procedure Identifier / Number, Marketing Authorization Application.Application Identifier / Number
The type of a case involved in an application.
Marketing Authorization Procedure.Procedure Type, Marketing Authorization Application.Application Type
Marketing Authorization Procedure.Procedure Date Start, Marketing Authorization Procedure.Procedure Date End, Marketing Authorization Application.Application Date
Applications submitted to obtain a regulated authorization. Steps within the longer running case or procedure
A regulatory submission from an organization to a regulator, as part of an assessing case. Multiple applications may occur over time, with more or different information to support or modify the submission or the authorization. The applications can be considered as steps within the longer running case or procedure for this authorization process.
Marketing Authorization.Marketing Authorization Application
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](extensibility.html#modifierExtension).