FHIRsmith: RegulatedAuthorization/RegulatedAuthorization-MA-12345601.json

FHIR IG analytics

Package	ch.fhir.ig.ch-idmp
Resource Type	RegulatedAuthorization
Id	RegulatedAuthorization-MA-12345601.json
FHIR Version	R5

Resources that use this resource

No resources found

Resources that this resource uses

No resources found

Narrative

Note: links and images are rebased to the (stated) source

Generated Narrative: RegulatedAuthorization MA-12345601

Profile: RegulatedAuthorization

identifier: Marketing Authorisation Number/12345601

subject: MedicinalProductDefinition: extension = Cream + Pessary; identifier = http://fhir.ch/ig/ch-idmp/sid/mpid#Medical Product Identifier#CH-11111111-1234560010000; combinedPharmaceuticalDoseForm = Cream + Pessary; indication = Comprehensive Sample Combipack wird angewendet zur Behandlung der bakteriellen Vaginose (früher bezeichnet als Haemophilus-Vaginitis, Gardnerella-Vaginitis, unspezifische Vaginitis, Corynebacterium-Vaginitis oder anaerobe Vaginose); legalStatusOfSupply = D: Dispensed following expert advice; additionalMonitoringIndicator = No Warning; pediatricUseIndicator = Not authorised for the treatment in children; classification = nystatin,NA NAS,Synthetic

type: Marketing Authorisation

region: Switzerland

status: approved

statusDate: 2023-11-07

validityPeriod: 2023-11-07 --> 2028-11-06

holder: Organization Example AG

regulator: Organization SMC

Generated Narrative: Organization #holder-Example-AG

Profile: Organization
identifier: Swissmedic Location Identifier/12345678, LOC Identifier/0123456789, GLN Identifier/7601123456789
name: Example AG

Generated Narrative: Organization #regulator-SMC

Profile: Organization
identifier: LOC Identifier/100010911, GLN Identifier/7601001398511
name: SMC

Source1

{
  "resourceType": "RegulatedAuthorization",
  "id": "MA-12345601",
  "meta": {
    "profile": [
      "http://fhir.ch/ig/ch-idmp/StructureDefinition/ch-idmp-regulatedauthorization"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "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": "12345601"
    }
  ],
  "subject": [
    {
      "reference": "MedicinalProductDefinition/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"
  }
}