EMA Write PMS API Implementation Guide - Enrichments
1.0.0 - ci-build

EMA Write PMS API Implementation Guide - Enrichments - Local Development build (v1.0.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions

: 3. Change pack size (response) - JSON Representation

Raw json | Download

{
  "resourceType" : "Bundle",
  "id" : "490a41c4-5f57-4444-80f7-e2734b193dc3",
  "meta" : {
    "profile" : [
      "http://ema.europa.eu/fhir/definition/esmp/Bundle-variation/0.1.1"
    ]
  },
  "type" : "transaction",
  "entry" : [
    //  this will exist but is commented out in the IG temporarily 
    // profile value="http://hl7.org/fhir/5.0/StructureDefinition/Bundle" /
    {
      "fullUrl" : "http://ema.europa.eu/example/api/MedicinalProductDefinition/600000709068",
      "resource" : {
        "resourceType" : "MedicinalProductDefinition",
        "id" : "600000709068",
        "meta" : {
          "versionId" : "3"
        },
        "text" : {
          "status" : "extensions",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_600000709068\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition 600000709068</b></p><a name=\"600000709068\"> </a><a name=\"hc600000709068\"> </a><a name=\"600000709068-en-US\"> </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\">version: 3</p></div><p><b>Authorised Dose Form</b>: <a href=\"CodeSystem-200000000004.html#200000000004-100000073683\">Pharmaceutical Dose Form 100000073683</a>: Prolonged-release tablet</p><p><b>identifier</b>: <code>http://spor.azure-api.net/pms/api/v2</code>/6055417, <code>http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665</code>/PRD417562</p><p><b>domain</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000000004 100000000012}\">Human use</span></p><p><b>status</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000005003 200000005007}\">Nullified</span></p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000000006 100000073683}\">Prolonged-release tablet</span></p><p><b>additionalMonitoringIndicator</b>: <span title=\"Codes:{http://ema.europa.eu/fhir/additionalMonitoringIndicator False}\">False</span></p><p><b>pediatricUseIndicator</b>: <span title=\"Codes:{http://ema.europa.eu/fhir/paediatricUseIndicator True}\">True</span></p><p><b>classification</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000093533 100000098024}\">100000098024</span>, <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000116045 100000116046}\">Full application (Article 8(3) of Directive No 2001/83/EC)</span>, <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000000324 200000003517}\">Other</span></p><p><b>attachedDocument</b>: <a href=\"DocumentReference-13709.html\">DocumentReference: status = current</a></p><p><b>masterFile</b>: <a href=\"DocumentReference-mf1.html\">DocumentReference: status = current</a></p><blockquote><p><b>contact</b></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000154441 200000017719}\">Pharmacovigilance Enquiry Information</span></p><p><b>contact</b>: <a href=\"Organization-phv5633366.html\">Organization Dummmy Organization</a></p></blockquote><blockquote><p><b>contact</b></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000154441 100000155057}\">Qualified Person in the EEA for Pharmacovigilance</span></p><p><b>contact</b>: <a href=\"PractitionerRole-qppv5633367.html\">PractitionerRole </a></p></blockquote><blockquote><p><b>name</b></p><p><b>productName</b>: StopCold 5 mg/120 mg comprimidos de liberación prolongada.</p><blockquote><p><b>part</b></p><p><b>part</b>: StopCold</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000002}\">Invented name part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 5 MG/120 MG</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000004}\">Strength part</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: COMPRIMIDOS DE LIBERACIÓN PROLONGADA</p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000000 220000000005}\">Pharmaceutical dose form part</span></p></blockquote><h3>Usages</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Country</b></td><td><b>Language</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/100000000002 100000000529}\">Spain</span></td><td><span title=\"Codes:{urn:ietf:bcp:47 es}, {http://spor.ema.europa.eu/v1/lists/100000072057 100000072264}\">Spanish</span></td></tr></table></blockquote><blockquote><p><b>operation</b></p><blockquote><p><b>id</b></p>6519944</blockquote><h3>Types</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"ActivityDefinition-7371703.html\">This is a dummy resource, to make the PMS examples links resolve for QA purposes - but these are not supported in the API currently</a></td></tr></table><p><b>confidentialityIndicator</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000004983 200000004984}\">Confidential</span></p></blockquote><blockquote><p><b>operation</b></p><h3>Types</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-490a41c4-5f57-4444-80f7-e2734b193dc3.html#urn-uuid-a57ef872-40cf-4bc8-a486-211ba46f367f\">Bundle: type = transaction</a></td></tr></table><p><b>confidentialityIndicator</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/200000004983 200000004985}\">Public</span></p></blockquote></div>"
        },
        "extension" : [
          {
            "url" : "http://ema.europa.eu/fhir/extension/authorisedDoseForm",
            "valueCoding" : {
              "extension" : [
                {
                  "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                  "valueInteger" : 38
                }
              ],
              "system" : "http://spor.ema.europa.eu/v1/lists/200000000004",
              "code" : "100000073683"
            }
          }
        ],
        "identifier" : [
          {
            "system" : "http://spor.azure-api.net/pms/api/v2",
            "value" : "6055417"
          },
          {
            "system" : "http://spor.ema.europa.eu/v1/lists/100000000009/terms/100000075665",
            "value" : "PRD417562"
          }
        ],
        "domain" : {
          "coding" : [
            {
              "extension" : [
                {
                  "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                  "valueInteger" : 7
                }
              ],
              "system" : "http://spor.ema.europa.eu/v1/lists/100000000004",
              "code" : "100000000012"
            }
          ]
        },
        "status" : {
          "coding" : [
            {
              "extension" : [
                {
                  "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                  "valueInteger" : 3
                }
              ],
              "system" : "http://spor.ema.europa.eu/v1/lists/200000005003",
              "code" : "200000005007"
            }
          ]
        },
        "combinedPharmaceuticalDoseForm" : {
          "coding" : [
            {
              "extension" : [
                {
                  "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                  "valueInteger" : 38
                }
              ],
              "system" : "http://spor.ema.europa.eu/v1/lists/200000000006",
              "code" : "100000073683"
            }
          ]
        },
        "additionalMonitoringIndicator" : {
          "coding" : [
            {
              "system" : "http://ema.europa.eu/fhir/additionalMonitoringIndicator",
              "code" : "False"
            }
          ]
        },
        "pediatricUseIndicator" : {
          "coding" : [
            {
              "system" : "http://ema.europa.eu/fhir/paediatricUseIndicator",
              "code" : "True"
            }
          ]
        },
        "classification" : [
          {
            "coding" : [
              {
                "extension" : [
                  {
                    "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                    "valueInteger" : 3
                  }
                ],
                "system" : "http://spor.ema.europa.eu/v1/lists/100000093533",
                "code" : "100000098024"
              }
            ]
          },
          {
            "coding" : [
              {
                "extension" : [
                  {
                    "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                    "valueInteger" : 8
                  }
                ],
                "system" : "http://spor.ema.europa.eu/v1/lists/100000116045",
                "code" : "100000116046"
              }
            ]
          },
          {
            "coding" : [
              {
                "extension" : [
                  {
                    "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                    "valueInteger" : 2
                  }
                ],
                "system" : "http://spor.ema.europa.eu/v1/lists/200000000324",
                "code" : "200000003517"
              }
            ]
          }
        ],
        "attachedDocument" : [
          {
            🔗 "reference" : "DocumentReference/13709"
          }
        ],
        "masterFile" : [
          {
            🔗 "reference" : "DocumentReference/mf1"
          }
        ],
        "contact" : [
          {
            "type" : {
              "coding" : [
                {
                  "extension" : [
                    {
                      "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                      "valueInteger" : 3
                    }
                  ],
                  "system" : "http://spor.ema.europa.eu/v1/lists/100000154441",
                  "code" : "200000017719"
                }
              ]
            },
            "contact" : {
              🔗 "reference" : "Organization/phv5633366"
            }
          },
          {
            "type" : {
              "coding" : [
                {
                  "extension" : [
                    {
                      "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                      "valueInteger" : 1
                    }
                  ],
                  "system" : "http://spor.ema.europa.eu/v1/lists/100000154441",
                  "code" : "100000155057"
                }
              ]
            },
            "contact" : {
              🔗 "reference" : "PractitionerRole/qppv5633367"
            }
          }
        ],
        "name" : [
          {
            "productName" : "StopCold 5 mg/120 mg comprimidos de liberación prolongada.",
            "part" : [
              {
                "part" : "StopCold",
                "type" : {
                  "coding" : [
                    {
                      "extension" : [
                        {
                          "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                          "valueInteger" : 9
                        }
                      ],
                      "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                      "code" : "220000000002"
                    }
                  ]
                }
              },
              {
                "part" : "5 MG/120 MG",
                "type" : {
                  "coding" : [
                    {
                      "extension" : [
                        {
                          "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                          "valueInteger" : 9
                        }
                      ],
                      "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                      "code" : "220000000004"
                    }
                  ]
                }
              },
              {
                "part" : "COMPRIMIDOS DE LIBERACIÓN PROLONGADA",
                "type" : {
                  "coding" : [
                    {
                      "extension" : [
                        {
                          "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                          "valueInteger" : 8
                        }
                      ],
                      "system" : "http://spor.ema.europa.eu/v1/lists/220000000000",
                      "code" : "220000000005"
                    }
                  ]
                }
              }
            ],
            "usage" : [
              {
                "country" : {
                  "coding" : [
                    {
                      "extension" : [
                        {
                          "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                          "valueInteger" : 19
                        }
                      ],
                      "system" : "http://spor.ema.europa.eu/v1/lists/100000000002",
                      "code" : "100000000529"
                    }
                  ]
                },
                "language" : {
                  "coding" : [
                    //  language needs an international code, which matches the RMS code 
                    {
                      "system" : "urn:ietf:bcp:47",
                      "code" : "es"
                    },
                    {
                      "extension" : [
                        {
                          "url" : "http://ema.europa.eu/fhir/extension/termVersion",
                          "valueInteger" : 2
                        }
                      ],
                      "system" : "http://spor.ema.europa.eu/v1/lists/100000072057",
                      "code" : "100000072264"
                    }
                  ]
                }
              }
            ]
          }
        ],
        "operation" : [
          {
            "id" : "6519944",
            "type" : {
              "reference" : {
                🔗 "reference" : "ActivityDefinition/7371703"
              }
            },
            "confidentialityIndicator" : {
              "coding" : [
                {
                  "system" : "http://spor.ema.europa.eu/v1/lists/200000004983",
                  "code" : "200000004984"
                }
              ]
            }
          },
          {
            "type" : {
              "reference" : {
                "reference" : "urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f"
              }
            },
            "confidentialityIndicator" : {
              "coding" : [
                {
                  "system" : "http://spor.ema.europa.eu/v1/lists/200000004983",
                  "code" : "200000004985"
                }
              ]
            }
          }
        ]
      },
      "request" : {
        "method" : "PUT",
        "url" : "MedicinalProductDefinition/600000709068"
      }
    },
    {
      "fullUrl" : "urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f",
      "resource" : {
        "resourceType" : "ActivityDefinition",
        "text" : {
          "status" : "extensions",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"ActivityDefinition_null\"> </a>\n<div>\n    <table class=\"grid dict\">\n\n        \n\n        \n\n        \n\n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Effective Period: </b></th>\n            <td style=\"padding-left: 4px;\">2025-03-31..</td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n        \n        \n\n        \n        <tr>\n            <th scope=\"row\"><b>Code: </b></th>\n            <td style=\"padding-left: 4px;\">\n                \n                    \n                        \n                            <p><b>system: </b><span><a href=\"CodeSystem-100000160406.html\">http://spor.ema.europa.eu/v1/lists/100000160406</a></span></p>\n                        \n                        \n                            <p><b>code: </b><span>100000160480</span></p>\n                        \n                        \n                    \n                \n                \n            </td>\n        </tr>\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n\n        \n    </table>\n</div>\n</div>"
        },
        "status" : "active",
        "effectivePeriod" : {
          "start" : "2025-03-31"
        },
        "code" : {
          "coding" : [
            {
              "system" : "http://spor.ema.europa.eu/v1/lists/100000160406",
              "code" : "100000160480"
            }
          ]
        },
        "participant" : [
          {
            "type" : "organization",
            "typeReference" : {
              "identifier" : {
                "system" : "http://spor.ema.europa.eu/v1/locations",
                "value" : "LOC-100068460"
              },
              "display" : "Pharma X"
            }
          }
        ]
      },
      "request" : {
        "method" : "POST",
        "url" : "ActivityDefinition"
      }
    },
    {
      "fullUrl" : "urn:uuid:34aac3e5-6c44-45fd-9a57-4c3cb638a13c",
      "resource" : {
        "resourceType" : "RegulatedAuthorization",
        "text" : {
          "status" : "generated",
          "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"RegulatedAuthorization_null\"> </a><p class=\"res-header-id\"><b>Generated Narrative: RegulatedAuthorization </b></p><p><b>identifier</b>: <code>http://ema.europa.eu/fhir/manufacturingAuthorizationNumber</code>/12345</p><p><b>subject</b>: <a href=\"Bundle-490a41c4-5f57-4444-80f7-e2734b193dc3.html#urn-uuid-a57ef872-40cf-4bc8-a486-211ba46f367f\">Bundle: type = transaction</a></p><p><b>type</b>: <span title=\"Codes:{http://spor.ema.europa.eu/v1/lists/220000000060 220000000099}\">Manufacturing Authorisation</span></p><p><b>validityPeriod</b>: 2025-03-31 --&gt; (ongoing)</p><p><b>regulator</b>: Finnish Medicines Agency (Identifier: <code>http://spor.ema.europa.eu/v1/locations</code>/LOC-100000015)</p></div>"
        },
        "identifier" : [
          {
            "system" : "http://ema.europa.eu/fhir/manufacturingAuthorizationNumber",
            "value" : "12345"
          }
        ],
        "subject" : [
          {
            "reference" : "urn:uuid:a57ef872-40cf-4bc8-a486-211ba46f367f"
          }
        ],
        "type" : {
          "coding" : [
            {
              "system" : "http://spor.ema.europa.eu/v1/lists/220000000060",
              "code" : "220000000099"
            }
          ]
        },
        "validityPeriod" : {
          "start" : "2025-03-31"
        },
        "regulator" : {
          "identifier" : {
            "system" : "http://spor.ema.europa.eu/v1/locations",
            "value" : "LOC-100000015"
          },
          "display" : "Finnish Medicines Agency"
        }
      },
      "request" : {
        "method" : "POST",
        "url" : "RegulatedAuthorization"
      }
    }
  ]
}