R4 Ballot #1 #2 (Mixed Normative/Trial use)

This page is part of the FHIR Specification (v3.3.0: (v3.5.0: R4 Ballot 2). #2). The current version which supercedes this version is 5.0.0 . For a full list of available versions, see the Directory of published versions

Medicinalproductauthorization-example

Biomedical Research and Regulation Work Group Maturity Level : N/A Ballot Status : Informative Compartments : Not linked to any defined compartments

This is the narrative for the resource. See also the XML or , JSON or Turtle format. This example conforms to the profile MedicinalProductAuthorization .

Generated Narrative with Details

id : example

identifier : 49476534 EU/1/11/999/001

actuality country : actual EU (Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)

event legalStatusOfSupply : This was a mild rash on the left forearm Subjecttomedicalprescription (Details : {SNOMED CT {http://ema.europa.eu/example/legalstatusofsupply code '304386008' 'Subjecttomedicalprescription' = 'O/E - itchy rash', given as 'O/E - itchy rash'}) 'Subjecttomedicalprescription)

subject status : Patient/example active (Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)

date statusDate : 29/01/2017 12:34:56 PM 14/01/2015

seriousness validityPeriod : Non-serious 16/08/2015 --> 20/05/2020

dataExclusivityPeriod : 15/08/2010 --> 15/08/2020

dateOfFirstAuthorization : 15/08/2010

internationalBirthDate : 15/08/2010

jurisdictionalAuthorization

identifier : 123-456-789

country : NO (Details : {http://hl7.org/fhir/adverse-event-seriousness {http://ema.europa.eu/example/countryCode code 'Non-serious' 'NO' = 'Non-serious', given as 'Non-serious'}) 'NO)

severity jurisdictionalAuthorization

identifier : Mild 123-456-123

country : NO (Details : {http://hl7.org/fhir/adverse-event-severity {http://ema.europa.eu/example/countryCode code 'Mild' 'NO' = 'Mild', given as 'Mild'}) 'NO)

recorder holder : Practitioner/example Organization/example

SuspectEntities

regulator : Organization/example

-

Instance procedure

identifier : EMEA/H/C/009999/IA/0099/G

type : VariationTypeIA (Details : {http://ema.europa.eu/example/marketingAuthorisationProcedureType code 'VariationTypeIA' = 'VariationTypeIA)

date : 02/08/2015 --> 21/08/2015

Applications

Medication/example
* -
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Other examples that reference this example:

  • MedicinalProduct/General

    •  

    Usage note: every effort has been made to ensure that the examples are correct and useful, but they are not a normative part of the specification.