This page is part of the FHIR Specification (v3.5.0: R4 Ballot #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
Biomedical Research and Regulation Work Group | Maturity Level: N/A | Ballot Status: Informative | Compartments: Not linked to any defined compartments |
Raw JSON (canonical form + also see JSON Format Specification)
Example of medicinalproductauthorization
{ "resourceType": "MedicinalProductAuthorization", "id": "example", "text": { "status": "generated", "div": "<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>country</b>: EU <span>(Details : {http://ema.europa.eu/example/country code 'EU' = 'EU)</span></p><p><b>legalStatusOfSupply</b>: Subjecttomedicalprescription <span>(Details : {http://ema.europa.eu/example/legalstatusofsupply code 'Subjecttomedicalprescription' = 'Subjecttomedicalprescription)</span></p><p><b>status</b>: active <span>(Details : {http://ema.europa.eu/example/authorisationstatus code 'active' = 'active)</span></p><p><b>statusDate</b>: 14/01/2015</p><p><b>validityPeriod</b>: 16/08/2015 --> 20/05/2020</p><p><b>dataExclusivityPeriod</b>: 15/08/2010 --> 15/08/2020</p><p><b>dateOfFirstAuthorization</b>: 15/08/2010</p><p><b>internationalBirthDate</b>: 15/08/2010</p><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-789</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><blockquote><p><b>jurisdictionalAuthorization</b></p><p><b>identifier</b>: 123-456-123</p><p><b>country</b>: NO <span>(Details : {http://ema.europa.eu/example/countryCode code 'NO' = 'NO)</span></p></blockquote><p><b>holder</b>: <a>Organization/example</a></p><p><b>regulator</b>: <a>Organization/example</a></p><blockquote><p><b>procedure</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>: 02/08/2015 --> 21/08/2015</p><h3>Applications</h3><table><tr><td>-</td></tr><tr><td>*</td></tr></table></blockquote></div>" }, "identifier": [ { "system": "http://ema.europa.eu/example/marketingAuthorisationNumber", "value": "EU/1/11/999/001" } ], "country": [ { "coding": [ { "system": "http://ema.europa.eu/example/country", "code": "EU" } ] } ], "legalStatusOfSupply": { "coding": [ { "system": "http://ema.europa.eu/example/legalstatusofsupply", "code": "Subjecttomedicalprescription" } ] }, "status": { "coding": [ { "system": "http://ema.europa.eu/example/authorisationstatus", "code": "active" } ] }, "statusDate": "2015-01-14", "validityPeriod": { "start": "2015-08-16", "end": "2020-05-20" }, "dataExclusivityPeriod": { "start": "2010-08-15", "end": "2020-08-15" }, "dateOfFirstAuthorization": "2010-08-15", "internationalBirthDate": "2010-08-15", "jurisdictionalAuthorization": [ { "id": "1", "identifier": [ { "system": "http://ema.europa.eu/example/marketingauthorisationnumber", "value": "123-456-789" } ], "country": { "coding": [ { "system": "http://ema.europa.eu/example/countryCode", "code": "NO" } ] } }, { "id": "2", "identifier": [ { "system": "http://ema.europa.eu/example/marketingauthorisationnumber", "value": "123-456-123" } ], "country": { "coding": [ { "system": "http://ema.europa.eu/example/countryCode", "code": "NO" } ] } } ], "holder": { "reference": "Organization/example" }, "regulator": { "reference": "Organization/example" }, "procedure": { "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": "2015-08-02", "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" } ] } }
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.