SMART Product Dataset for Prequalified Vaccines
0.2.0 - ci-build

SMART Product Dataset for Prequalified Vaccines, published by WHO. This guide is not an authorized publication; it is the continuous build for version 0.2.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/litlfred/smart-pcmt-vaxprequal/ and changes regularly. See the Directory of published versions

Example Binary: PreQual Product: Measles and Rubella Vaccine Live Attenuated - MR

This content is an example of the WHO Vaccine PreQual DB - Finished Vaccine Products Logical Model and is not a FHIR Resource

    
{
  "resourceType": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/FinishedVaccineProducts",
  "productType": "FinishedVaccineProduct",
  "dateOfPrequal": "1993-02-15",
  "assessmentProcedure": "PrequalificationStandard",
  "status": "Prequalified",
  "pharmaceuticalForm": "Lyophilisedactivecomponenttobereconstitutedwithexcipientdiluentbeforeuse",
  "presentation": {
    "coding": [
      {
        "system": "https://extranet.who.int/prequal/vaccines/prequalified-vaccines",
        "code": "Vial",
        "display": "Vial"
      }
    ]
  },
  "numDoses": 2,
  "productId": {
    "system": "https://extranet.who.int/prequal/api",
    "value": "a3K3X000006MiiGUAS"
  },
  "productName": "FVP-P-138",
  "vaccineFullName": "Measles, rubella combined vaccine (live, attenuated)",
  "vaccineAbbreviatedName": "MR",
  "vaccineCommercialName": "Measles and Rubella Vaccine Live Attenuated",
  "vaccineTypeId": {
    "system": "https://extranet.who.int/prequal/api",
    "value": "a3S3X000003cSpbUAE"
  },
  "routeOfAdministration": "Subcutaneous",
  "vialMonitor": "Type 14",
  "multidoseVialPolicy": "WHO recommends that opened vials of this vaccine should be discarded 6 hours after opening or at the end of the immunization session, whichever comes first.",
  "applicantId": {
    "system": "https://extranet.who.int/prequal/api",
    "value": "0013X00003cPkzfQAC"
  },
  "applicantName": "Serum Institute of India",
  "nraId": {
    "system": "https://extranet.who.int/prequal/api",
    "value": "0013X0000498p4fQAA"
  },
  "nraName": "Central Drugs Standard Control Organization (CDSCO)",
  "nraCountry": "India",
  "shelfLife": "30 months",
  "storageTemperature": "2 - 8°C",
  "diluent": "Water for injection",
  "lastPublishingDate": "2024-09-10",
  "publishingRemarks": "An extension of shelf life at 2-8°C from 24 to 30 months was approved on 10 January 2018 ans the Product Insert (PI) indicating this shelf life is part of this web listing. However for some time stock on-hand manufactured before this approval date may be supplied and the PI for these batches will still indicate a 24 month shelf life.",
  "manufacturerReference": {
    "reference": "Organization/Manufacturer0013X00003cPkzfQAC"
  },
  "responsibleNRAReference": {
    "reference": "Organization/Holder0013X0000498p4fQAA"
  },
  "manufacturerLM": {
    "reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualManufacturer/PreQualManufacturer0013X00003cPkzfQAC"
  },
  "nraLM": {
    "reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualNRA/PreQualNRA0013X0000498p4fQAA"
  },
  "vaccineLM": {
    "reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualVaccine/PreQualVaccinea3S3X000003cSpbUAE"
  },
  "packagingLM": [
    {
      "reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualProductPackaging/PreQualPackaginga3H3X000001VabEUAS"
    }
  ],
  "documentLM": [
    {
      "reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualDocumentDetail/PreQualDocument069NN000005iLInYAM"
    }
  ],
  "siteLM": [
    {
      "reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualSiteDetail/PreQualSite0013X00003cPkzfQAC"
    }
  ],
  "ingredientLM": [
    {
      "reference": "http://smart.who.int/pcmt-vaxprequal/StructureDefinition/PreQualProductIngredient/PreQualIngredienta3K3X000006MiiGUASIng3"
    }
  ]
}