MedicinalProductAuthorization

The regulatory authorization of a medicinal product.

Schema

Elements

Name	Required	Type	Description
identifier		Identifier[]	Business identifier for the marketing authorization, as assigned by a regulator Details Business identifier for the marketing authorization, as assigned by a regulator.
subject		Reference<MedicinalProduct | MedicinalProductPackaged>	The medicinal product that is being authorized Details The medicinal product that is being authorized.
country		CodeableConcept[]	The country in which the marketing authorization has been granted Details The country in which the marketing authorization has been granted.
jurisdiction		CodeableConcept[]	Jurisdiction within a country Details Jurisdiction within a country.
status		CodeableConcept	The status of the marketing authorization Details The status of the marketing authorization.
statusDate		dateTime	The date at which the given status has become applicable Details The date at which the given status has become applicable.
restoreDate		dateTime	The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored Details The date when a suspended the marketing or the marketing authorization of the product is anticipated to be restored.
validityPeriod		Period	The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format Details The beginning of the time period in which the marketing authorization is in the specific status shall be specified A complete date consisting of day, month and year shall be specified using the ISO 8601 date format.
dataExclusivityPeriod		Period	A period of time after authorization before generic product applicatiosn can be submitted Details A period of time after authorization before generic product applicatiosn can be submitted.
dateOfFirstAuthorization		dateTime	The date when the first authorization was granted by a Medicines Regulatory Agency Details The date when the first authorization was granted by a Medicines Regulatory Agency.
internationalBirthDate		dateTime	Date of first marketing authorization for a company's new medicinal product in any country in the World Details Date of first marketing authorization for a company's new medicinal product in any country in the World.
legalBasis		CodeableConcept	The legal framework against which this authorization is granted Details The legal framework against which this authorization is granted.
jurisdictionalAuthorization		MedicinalProductAuthorizationJurisdictionalAuthorization[]	Authorization in areas within a country Details Authorization in areas within a country.
id		string	Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
extension		Extension[]	Additional content defined by implementations Details 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. 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.
modifierExtension		Extension[]	Extensions that cannot be ignored even if unrecognized Details 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). 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.
identifier		Identifier[]	The assigned number for the marketing authorization Details The assigned number for the marketing authorization.
country		CodeableConcept	Country of authorization Details Country of authorization.
jurisdiction		CodeableConcept[]	Jurisdiction within a country Details Jurisdiction within a country.
legalStatusOfSupply		CodeableConcept	The legal status of supply in a jurisdiction or region Details The legal status of supply in a jurisdiction or region.
validityPeriod		Period	The start and expected end date of the authorization Details The start and expected end date of the authorization.
holder		Reference<Organization>	Marketing Authorization Holder Details Marketing Authorization Holder.
regulator		Reference<Organization>	Medicines Regulatory Agency Details Medicines Regulatory Agency.
procedure		MedicinalProductAuthorizationProcedure	The regulatory procedure for granting or amending a marketing authorization Details The regulatory procedure for granting or amending a marketing authorization.
id		string	Unique id for inter-element referencing Details Unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.
extension		Extension[]	Additional content defined by implementations Details 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. 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.
modifierExtension		Extension[]	Extensions that cannot be ignored even if unrecognized Details 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). 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.
identifier		Identifier	Identifier for this procedure Details Identifier for this procedure.
type	✓	CodeableConcept	Type of procedure Details Type of procedure.
date[x]		Period, dateTime	Date of procedure Details Date of procedure.
application		[]	Applcations submitted to obtain a marketing authorization Details Applcations submitted to obtain a marketing authorization.

Search Parameters

Name	Type	Description	Expression
country	token	The country in which the marketing authorization has been granted	MedicinalProductAuthorization.country
holder	reference	Marketing Authorization Holder	MedicinalProductAuthorization.holder
identifier	token	Business identifier for the marketing authorization, as assigned by a regulator	MedicinalProductAuthorization.identifier
status	token	The status of the marketing authorization	MedicinalProductAuthorization.status
subject	reference	The medicinal product that is being authorized	MedicinalProductAuthorization.subject

Inherited Elements

Name	Required	Type	Description
id		string	Logical id of this artifact Details The logical id of the resource, as used in the URL for the resource. Once assigned, this value never changes. The only time that a resource does not have an id is when it is being submitted to the server using a create operation.
meta		Meta	Metadata about the resource Details 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.
implicitRules		uri	A set of rules under which this content was created Details 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 it's narrative along with other profiles, value sets, etc.
language		code	Language of the resource content Details 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		Narrative	Text summary of the resource, for human interpretation Details 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 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.
contained		Resource[]	Contained, inline Resources Details These resources do not have an independent existence apart from the resource that contains them - they cannot be identified independently, and nor can they have their own independent transaction scope. 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.
extension		Extension[]	Additional content defined by implementations Details 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. 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.
modifierExtension		Extension[]	Extensions that cannot be ignored Details 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). 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.

Usage

This resource is still undergoing development and review by the appropriate Workgroups. At this time, is considered only as a draft resource not suitable for production implementation

MedicinalProductAuthorization is a resource covering the Marketing Authorization of a Medicinal Product, from a regulatory point of view.

Referenced By

• MedicinalProductPackaged