This page is part of the FHIR Specification (v4.2.0: R5 Preview #1). The current version which supercedes this version is 5.0.0. For a full list of available versions, see the Directory of published versions . Page versions: R5 R4B
Biomedical Research and Regulation Work Group | Maturity Level: N/A | Standards Status: Informative | Compartments: Not linked to any defined compartments |
Raw XML (canonical form + also see XML Format Specification)
Example of regulatedauthorization (id = "example")
<?xml version="1.0" encoding="UTF-8"?> <RegulatedAuthorization xmlns="http://hl7.org/fhir"> <id value="example"/> <text> <status value="generated"/> <div xmlns="http://www.w3.org/1999/xhtml"><p> <b> Generated Narrative with Details</b> </p> <p> <b> id</b> : example</p> <p> <b> identifier</b> : EU/1/11/999/001</p> <p> <b> region</b> : EU <span> (Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)</span> </p> <p> <b> status</b> : active <span> (Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)</span> </p> <p> <b> statusDate</b> : 2015-01-14</p> <p> <b> validityPeriod</b> : 2015-08-16 --> 2020-05-20</p> <p> <b> jurisdictionalAuthorization</b> : <a> RegulatedAuthorization/Jurusdictional1</a> </p> <p> <b> holder</b> : <a> Organization/example</a> </p> <p> <b> regulator</b> : <a> Organization/example</a> </p> <blockquote> <p> <b> case</b> </p> <p> <b> identifier</b> : EMEA/H/C/009999/IA/0099/G</p> <p> <b> type</b> : VariationTypeIA <span> (Details : {http://ema.europa.eu/example/marketingAuthorisationProcedureType code 'VariationTypeIA' = 'VariationTypeIA)</span> </p> <p> <b> date</b> : 2015-08-02 --> 2015-08-21</p> <h3> Applications</h3> <table> <tr> <td> -</td> </tr> <tr> <td> *</td> </tr> </table> </blockquote> </div> </text> <identifier> <system value="http://ema.europa.eu/example/marketingAuthorisationNumber"/> <value value="EU/1/11/999/001"/> </identifier> <region> <coding> <system value="http://ema.europa.eu/example/country"/> <code value="EU"/> </coding> </region> <status> <coding> <system value="http://ema.europa.eu/example/authorisationstatus"/> <code value="active"/> </coding> </status> <statusDate value="2015-01-14"/> <validityPeriod> <start value="2015-08-16"/> <end value="2020-05-20"/> </validityPeriod> <!-- dataExclusivityPeriod> <start value="2010-08-15"/> <end value="2020-08-15"/> </dataExclusivityPeriod> <dateOfFirstAuthorization value="2010-08-15"/> <internationalBirthDate value="2010-08-15"/ --> <jurisdictionalAuthorization id="1"> <reference value="RegulatedAuthorization/Jurusdictional1"/> </jurisdictionalAuthorization> <holder> <reference value="Organization/example"/> </holder> <regulator> <reference value="Organization/example"/> </regulator> <case> <identifier> <system value="http://ema.europa.eu/example/procedureidentifier-number"/> <value value="EMEA/H/C/009999/IA/0099/G"/> </identifier> <type> <coding> <system value="http://ema.europa.eu/example/marketingAuthorisationProcedureType"/> <code value="VariationTypeIA"/> </coding> </type> <datePeriod> <start value="2015-08-02"/> <end value="2015-08-21"/> </datePeriod> <application> <identifier> <system value="http://ema.europa.eu/example/applicationidentifier-number"/> <value value="IA38G"/> </identifier> <type> <coding> <system value="http://ema.europa.eu/example/marketingAuthorisationApplicationType"/> <code value="GroupTypeIAVariationNotification"/> </coding> </type> <dateDateTime value="2015-08-01"/> </application> </case> </RegulatedAuthorization>
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.