CH IDMP (R5)
1.0.0-ballot - ballot
CH IDMP (R5)
1.0.0-ballot - ballot
This page is part of the CH IDMP (v1.0.0-ballot: DSTU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. This is the current published version. For a full list of available versions, see the Directory of published versions
{
"resourceType" : "RegulatedAuthorization",
"id" : "MA-123456002",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization MA-123456002</b></p><a name=\"MA-123456002\"> </a><a name=\"hcMA-123456002\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-regulatedauthorization.html\">RegulatedAuthorization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-AuthNo.html\" title=\"Temporary Identifier in this implementation guide until officially released by Swissmedic\">Marketing Authorisation Number</a>/123456002</p><p><b>subject</b>: <a href=\"PackagedProductDefinition-PMP-Comprehensive-Sample-Combipack.html\">PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-idmp/sid/pcid#Clinical Product Identifier#CH-11111111-1234560010000-0002; containedItemQuantity = 1 Tube,6 Vaginal Tablet; description = Comprehensive Sample Combipack 40 g Salbe und 3 x 2 Vaginalzäpfchen</a></p><p><b>type</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs 756000002001}\">Marketing Authorisation</span></p><p><b>region</b>: <span title=\"Codes:{urn:iso:std:iso:3166 CH}\">Switzerland</span></p><p><b>status</b>: <span title=\"Codes:{http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status 756005010000001}\">approved</span></p><p><b>statusDate</b>: 2023-11-07</p><p><b>validityPeriod</b>: 2023-11-07 --> 2028-11-06</p><p><b>holder</b>: <a href=\"#hcMA-123456002/holder-Example-AG\">Organization Example AG</a></p><p><b>regulator</b>: <a href=\"#hcMA-123456002/regulator-SMC\">Organization SMC</a></p><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #holder-Example-AG</b></p><a name=\"MA-123456002/holder-Example-AG\"> </a><a name=\"hcMA-123456002/holder-Example-AG\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-organization.html\">Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-SMCLocID.html\" title=\"Temporary NamingSystem in this implementation guide until officially released by Swissmedic\">Swissmedic Location Identifier</a>/12345678, <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/0123456789, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601123456789</p><p><b>name</b>: Example AG</p></blockquote><hr/><blockquote><p class=\"res-header-id\"><b>Generated Narrative: Organization #regulator-SMC</b></p><a name=\"MA-123456002/regulator-SMC\"> </a><a name=\"hcMA-123456002/regulator-SMC\"> </a><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\"/><p style=\"margin-bottom: 0px\">Profile: <a href=\"StructureDefinition-ch-idmp-organization.html\">Organization</a></p></div><p><b>identifier</b>: <a href=\"NamingSystem-LOC.html\" title=\"Identifier holding a number for LocID (Location Identifier of the European Medicines Agency - Organisation Management System OMS)\">LOC Identifier</a>/100010911, <a href=\"NamingSystem-GLN.html\" title=\"Identifier holding a number for GLN (Global Location Number)\">GLN Identifier</a>/7601001398511</p><p><b>name</b>: SMC</p></blockquote></div>"
},
"contained" : [
{
"resourceType" : "Organization",
"id" : "holder-Example-AG",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
]
},
"identifier" : [
{
"system" : "https://www.swissmedic.ch/fhir/identifier/locations",
"value" : "12345678"
},
{
"system" : "https://spor.ema.europa.eu/v1/locations",
"value" : "0123456789"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601123456789"
}
],
"name" : "Example AG"
},
{
"resourceType" : "Organization",
"id" : "regulator-SMC",
"meta" : {
"profile" : [
🔗 "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-organization"
]
},
"identifier" : [
{
"system" : "https://spor.ema.europa.eu/v1/locations",
"value" : "100010911"
},
{
"system" : "urn:oid:2.51.1.3",
"value" : "7601001398511"
}
],
"name" : "SMC"
}
],
"identifier" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/sid/authno",
"value" : "123456002"
}
],
"subject" : [
{
🔗 "reference" : "PackagedProductDefinition/PMP-Comprehensive-Sample-Combipack"
}
],
"type" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-authorisation-type-cs",
"code" : "756000002001",
"display" : "Marketing Authorisation"
}
]
},
"region" : [
{
"coding" : [
{
"system" : "urn:iso:std:iso:3166",
"code" : "CH",
"display" : "Switzerland"
}
]
}
],
"status" : {
"coding" : [
{
"system" : "http://fhir.ch/ig/ch-idmp/CodeSystem/ch-SMC-authorisation-status",
"code" : "756005010000001",
"display" : "approved"
}
]
},
"statusDate" : "2023-11-07",
"validityPeriod" : {
"start" : "2023-11-07",
"end" : "2028-11-06"
},
"holder" : {
"reference" : "#holder-Example-AG"
},
"regulator" : {
"reference" : "#regulator-SMC"
}
}