This page is part of the FHIR Specification (v5.0.0-ballot: FHIR R5 Ballot Preview). 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 JSON (canonical form + also see JSON Format Specification)
General example
{ "resourceType": "RegulatedAuthorization", "id": "example", "text": { "status": "generated", "div": "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p><b>Generated Narrative: RegulatedAuthorization</b><a name=\"example\"> </a></p><div style=\"display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%\"><p style=\"margin-bottom: 0px\">Resource RegulatedAuthorization "example" </p></div><p><b>identifier</b>: id: EU/1/11/999/001</p><p><b>region</b>: EU <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (country#EU)</span></p><p><b>status</b>: active <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (authorisationstatus#active)</span></p><p><b>statusDate</b>: 2015-01-14</p><p><b>validityPeriod</b>: 2014-09-03 --> 2020-05-20</p><p><b>holder</b>: <span title=\" dataExclusivityPeriod>\n <start value="2010-08-15"/>\n <end value="2020-08-15"/>\n </dataExclusivityPeriod>\n <dateOfFirstAuthorization value="2010-08-15"/>\n <internationalBirthDate value="2010-08-15"/ &#10; jurisdictionalAuthorization id="1">\n <reference value="RegulatedAuthorization/Jurusdictional1"/>\n </jurisdictionalAuthorization \"><a href=\"todo.html\">Organization/example</a></span></p><p><b>regulator</b>: <a href=\"todo.html\">Organization/example</a></p><blockquote><p><b>case</b></p><p><b>identifier</b>: id: EMEA/H/C/009999/IA/0099/G</p><p><b>type</b>: VariationTypeIA <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorisationProcedureType#VariationTypeIA)</span></p><p><b>date</b>: 2014-09-02 --> 2015-08-21</p><h3>Applications</h3><table class=\"grid\"><tr><td>-</td><td><b>Identifier</b></td><td><b>Type</b></td><td><b>Date[x]</b></td></tr><tr><td>*</td><td>id: IA38G</td><td>GroupTypeIAVariationNotification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorisationApplicationType#GroupTypeIAVariationNotification)</span></td><td>2015-08-01</td></tr><tr><td>*</td><td>id: IA38F</td><td>GroupTypeIAVariationNotification <span style=\"background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki\"> (marketingAuthorisationApplicationType#GroupTypeIAVariationNotification)</span></td><td>2014-09-01</td></tr></table></blockquote></div>" }, "identifier": [ { "system": "http://ema.europa.eu/example/marketingAuthorisationNumber", "value": "EU/1/11/999/001" } ], "region": [ { "coding": [ { "system": "http://ema.europa.eu/example/country", "code": "EU" } ] } ], "status": { "coding": [ { "system": "http://ema.europa.eu/example/authorisationstatus", "code": "active" } ] }, "statusDate": "2015-01-14", "validityPeriod": { "start": "2014-09-03", "end": "2020-05-20" }, "holder": { "reference": "Organization/example" }, "regulator": { "reference": "Organization/example" }, "case": { "identifier": { "system": "http://ema.europa.eu/example/procedureidentifier-number", "value": "EMEA/H/C/009999/IA/0099/G" }, "type": { "coding": [ { "system": "http://ema.europa.eu/example/marketingAuthorisationProcedureType", "code": "VariationTypeIA" } ] }, "datePeriod": { "start": "2014-09-02", "end": "2015-08-21" }, "application": [ { "identifier": { "system": "http://ema.europa.eu/example/applicationidentifier-number", "value": "IA38G" }, "type": { "coding": [ { "system": "http://ema.europa.eu/example/marketingAuthorisationApplicationType", "code": "GroupTypeIAVariationNotification" } ] }, "dateDateTime": "2015-08-01" }, { "identifier": { "system": "http://ema.europa.eu/example/applicationidentifier-number", "value": "IA38F" }, "type": { "coding": [ { "system": "http://ema.europa.eu/example/marketingAuthorisationApplicationType", "code": "GroupTypeIAVariationNotification" } ] }, "dateDateTime": "2014-09-01" } ] } }
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.