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Packagech.fhir.ig.ch-epl
Resource TypeRegulatedAuthorization
IdRegulatedAuthorization-MA-66231001.json
FHIR VersionR5

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Narrative

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

Generated Narrative: RegulatedAuthorization MA-66231001

identifier: Marketing Authorisation Number/66231001

subject: PackagedProductDefinition: identifier = http://fhir.ch/ig/ch-epl/sid/pcid#Clinical Product Identifier#CH-01003060-0662310010000-0001; containedItemQuantity = 1 Vial; description = KEYTRUDA Inf Konz 100 mg/4ml Durchstf

type: Marketing Authorisation

region: Switzerland

status: valid

statusDate: 2022-02-17

holder: Organization MSD Merck Sharp & Dohme AG

regulator: Organization Swissmedic Swiss Agency for Therapeutic Products

Generated Narrative: Organization #holder-MSD-Merck-Sharp-Dohme-AG

Profile: Organization

identifier: Swissmedic Location Identifier/01003060, LOC Identifier/100080484, GLN Identifier/7601001001138

name: MSD Merck Sharp & Dohme AG

Generated Narrative: Organization #regulator-SMC

Profile: Organization

identifier: LOC Identifier/100010911, GLN Identifier/7601001398511

name: Swissmedic Swiss Agency for Therapeutic Products

Source1

{
  "resourceType": "RegulatedAuthorization",
  "id": "MA-66231001",
  "meta": {
    "profile": [
      "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-regulatedauthorization"
    ]
  },
  "text": {
    "status": "generated",
    "div": "<!-- snip (see above) -->"
  },
  "contained": [
    {
      "resourceType": "Organization",
      "id": "holder-MSD-Merck-Sharp-Dohme-AG",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-epl/StructureDefinition/ch-idmp-organization"
        ]
      },
      "identifier": [
        {
          "system": "https://www.swissmedic.ch/fhir/identifier/locations",
          "value": "01003060"
        },
        {
          "system": "https://spor.ema.europa.eu/v1/locations",
          "value": "100080484"
        },
        {
          "system": "urn:oid:2.51.1.3",
          "value": "7601001001138"
        }
      ],
      "name": "MSD Merck Sharp & Dohme AG"
    },
    {
      "resourceType": "Organization",
      "id": "regulator-SMC",
      "meta": {
        "profile": [
          "http://fhir.ch/ig/ch-epl/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": "Swissmedic Swiss Agency for Therapeutic Products"
    }
  ],
  "identifier": [
    {
      "system": "http://fhir.ch/ig/ch-epl/sid/authno",
      "value": "66231001"
    }
  ],
  "subject": [
    {
      "reference": "PackagedProductDefinition/PMP-Keytruda-100mg-4ml-Solution-for-Infusion"
    }
  ],
  "type": {
    "coding": [
      {
        "system": "http://fhir.ch/ig/ch-epl/CodeSystem/ch-authorisation-type",
        "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-epl/CodeSystem/ch-SMC-authorisation-status",
        "code": "756005023007",
        "display": "valid"
      }
    ]
  },
  "statusDate": "2022-02-17",
  "holder": {
    "reference": "#holder-MSD-Merck-Sharp-Dohme-AG"
  },
  "regulator": {
    "reference": "#regulator-SMC"
  }
}