{
    "resourceType":"MedicinalProductDefinition",
    "id": "Injectulin-contained",
    "meta":
    {
        "lastUpdated": "2017-11-12T00:00:00Z"
    },
    "contained":
    [{
        "resourceType":"DocumentReference",
        "id": "Injectulin-d3e5",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/identifier",
            "value": "{identifier}"
        },
        {
            "system": "http://example.com/fhir/documentVersionNumber",
            "value": "3"
        }],
        "status": "current",
        "type":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/type",
                "code": "SmPC"
            }]
        },
        "date": "2016-05-17T00:00:00Z",
        "content":
        [{
            "extension":
            [{
                "url": "http://ema.europa.eu/fhir/extension/documentLanguage", 
                "valueCode": "EN"
            }],
            "attachment":
            {
                "data": "e1BoeXNpY2FsQ2hhcmFjdGVyaXN0aWMuSW1hZ2V9"
            }
        }]
    },
    {
        "resourceType":"ClinicalUseDefinition",
        "id": "Injectulin-d3e25",
        "type": "contraindication",
        "subject":
        [{
            "reference": "MedicinalProductDefinition/Injectulin-contained"
        }],
        "contraindication":
        {
            "diseaseSymptomProcedure":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/contraindicationsasdisease-symptom-procedure",
                        "code": "Hypersensitivity"
                    }],
                    "text": "Hypersensitivity to the active substance or to any of the excipients\n         listed in section 6.1."
                }
            }
        }
    },
    {
        "resourceType":"RegulatedAuthorization",
        "id": "RA-1314TZ-d3e94",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber",
            "value": "1314TZ"
        }],
        "regulator":
        {
            "identifier":
            {
                "system": "https://spor.ema.europa.eu/v1/locations",
                "value": "Injectulin-regulator"
            }
        }
    },
    {
        "resourceType":"RegulatedAuthorization",
        "id": "Injectulin-d3e142",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/marketingAuthorisationNumber",
            "value": "EU/1/97/030/197"
        }],
        "subject":
        {
            "reference": "MedicinalProductDefinition/Injectulin-contained"
        },
        "type":
        {
            "coding":
            [{
                "system": "https://spor.ema.europa.eu/v1/lists/220000000060",
                "code": "220000000061",
                "display": "Marketing Authorisation"
            }]
        },
        "region":
        [{
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/country",
                "code": "EU"
            }]
        }],
        "status":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/authorisationstatus",
                "code": "Valid-VariedMarketingAuthorisation"
            }]
        },
        "statusDate": "2007-02-21",
        "validityPeriod":
        {
            "start": "2007-02-22"
        },
        "holder":
        {
            "identifier":
            {
                "system": "https://spor.ema.europa.eu/v1/locations",
                "value": "Injectulin-holder"
            }
        },
        "regulator":
        {
            "identifier":
            {
                "system": "https://spor.ema.europa.eu/v1/locations",
                "value": "Injectulin-regulator"
            }
        },
        "case":
        {
            "identifier":
            {
                "system": "http://ema.europa.eu/fhir/procedureidentifier-number",
                "value": "EMEA/H/C/000901"
            },
            "type":
            {
                "coding":
                [{
                    "system": "http://ema.europa.eu/fhir/marketingAuthorisationProcedureType",
                    "code": "EUauthorisationprocedures-CentralisedProcedure"
                }]
            },
            "datePeriod":
            {
                "start": "1995-12-06",
                "end": "1996-03-29"
            },
            "application":
            [{
                "identifier":
                {
                    "system": "http://ema.europa.eu/fhir/applicationidentifier-number",
                    "value": "IA38G"
                },
                "type":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/marketingAuthorisationApplicationType",
                        "code": "TypeIAVariationNotification"
                    }]
                },
                "dateDateTime": "2016-11-29"
            }]
        }
    },
    {
        "resourceType":"DocumentReference",
        "id": "Injectulin-d3e300",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/filecode",
            "value": "MFL9360"
        }],
        "status": "current",
        "type":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/filetype",
                "code": "{filetype}"
            }]
        },
        "custodian":
        {
            "identifier":
            {
                "system": "https://spor.ema.europa.eu/v1/locations",
                "value": "Injectulin-custodian"
            }
        },
        "content":
        [{
            "attachment":
            {
                "url": "http://example"
            }
        }]
    },
    {
        "resourceType":"PackagedProductDefinition",
        "id": "Injectulin-d3e363",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/pcid",
            "value": "{PCID}"
        }],
        "packageFor":
        [{
            "reference": "MedicinalProductDefinition/Injectulin-contained"
        }],
        "description": "VIAL.PACK SIZE:5 X 10 ML ",
        "packaging":
        {
            "type":
            {
                "coding":
                [{
                    "system": "http://ema.europa.eu/fhir/packageitemcontainertype",
                    "code": "Carton"
                }]
            },
            "quantity": "1",
            "material":
            [{
                "coding":
                [{
                    "system": "http://ema.europa.eu/fhir/packageItemContainerMaterial",
                    "code": "Paperboard"
                }]
            }],
            "manufacturer":
            {
                "identifier":
                {
                    "system": "https://spor.ema.europa.eu/v1/locations",
                    "value": "Injectulin-manufacturer"
                }
            },
            "packaging":
            [{
                "type":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/packageitemcontainertype",
                        "code": "Vial"
                    }]
                },
                "quantity": "1",
                "material":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/packageItemContainerMaterial",
                        "code": "type1colourlessglass"
                    }]
                },
                "shelfLifeStorage":
                {
                    "type":
                    {
                        "coding":
                        [{
                            "system": "http://ema.europa.eu/fhir/shelfLifeTypePlaceHolder",
                            "code": "ShelfLifeofPackagedMedicinalProduct"
                        }]
                    },
                    "periodDuration":
                    {
                        "value": 2,
                        "unit": "a"
                    }
                },
                "containedItem":
                [{
                    "item":
                    {
                        "reference":
                        {
                            "reference": "ManufacturedItemDefinition/Injectulin-d3e458"
                        }
                    },
                    "amount":
                    {
                        "value": 10,
                        "unit": "ml"
                    }
                }]
            }]
        }
    },
    {
        "resourceType":"RegulatedAuthorization",
        "id": "RA-NAYRTOB464-d3e435",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber",
            "value": "NAYRTOB464"
        }]
    },
    {
        "resourceType":"ManufacturedItemDefinition",
        "id": "Injectulin-d3e458",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "manufacturedDoseForm":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/manufactureddoseform",
                "code": "Solutionforinjection"
            }]
        },
        "unitOfPresentation":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/unitofpresentation",
                "code": "vial"
            }]
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e466",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "ActiveBase"
            }]
        },
        "manufacturer":
        [{
            "manufacturer":
            {
                "identifier":
                {
                    "system": "https://spor.ema.europa.eu/v1/locations",
                    "value": "Injectulin-manufacturer"
                }
            }
        },
        {
            "manufacturer":
            {
                "identifier":
                {
                    "system": "https://spor.ema.europa.eu/v1/locations",
                    "value": "Injectulin-manufacturer"
                }
            }
        }],
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "Insulinhuman"
                    }]
                }
            },
            "strength":
            [{
                "presentationRatio":
                {
                    "numerator":
                    {
                        "value": 100,
                        "unit": "IU"
                    },
                    "denominator":
                    {
                        "value": 1,
                        "unit": "ml"
                    }
                },
                "concentrationRatio":
                {
                    "numerator":
                    {
                        "value": 100,
                        "unit": "IU"
                    },
                    "denominator":
                    {
                        "value": 1,
                        "unit": "ml"
                    }
                }
            }]
        }
    },
    {
        "resourceType":"RegulatedAuthorization",
        "id": "RA-HDHG469834-d3e501",
        "identifier":
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            "system": "http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber",
            "value": "HDHG469834"
        }]
    },
    {
        "resourceType":"RegulatedAuthorization",
        "id": "RA-HDHG469834-d3e512",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber",
            "value": "HDHG469834"
        }]
    },
    {
        "resourceType":"RegulatedAuthorization",
        "id": "RA-HDGKD999999-d3e553",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber",
            "value": "HDGKD999999"
        }]
    },
    {
        "resourceType":"RegulatedAuthorization",
        "id": "RA-HDGKD999999-d3e564",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber",
            "value": "HDGKD999999"
        }]
    },
    {
        "resourceType":"RegulatedAuthorization",
        "id": "RA-HDGKD999999-d3e575",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/manufacturingauthorisationreferencenumber",
            "value": "HDGKD999999"
        }]
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e626",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "WATERFORINJECTION"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e647",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "HYDROCHLORICACID"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e667",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "METACRESOL"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e689",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "SODIUMHYDROXIDE"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e709",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "GLYCEROL"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"AdministrableProductDefinition",
        "id": "Injectulin-d3e745",
        "identifier":
        [{
            "system": "http://ema.europa.eu/fhir/phpididentifiersets",
            "value": "{PhPID}"
        }],
        "status": "active",
        "formOf":
        [{
            "reference": "MedicinalProductDefinition/Injectulin-contained"
        }],
        "administrableDoseForm":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/administrabledoseform",
                "code": "Solutionforinjection"
            }]
        },
        "routeOfAdministration":
        [{
            "code":
            {
                "coding":
                [{
                    "system": "http://ema.europa.eu/fhir/routeofadministration",
                    "code": "SUBCUTANEOUSUSE"
                }]
            }
        }]
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e766",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "ActiveBase"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "InsulinHuman"
                    }]
                }
            },
            "strength":
            [{
                "presentationRatio":
                {
                    "numerator":
                    {
                        "value": 100,
                        "unit": "IU"
                    },
                    "denominator":
                    {
                        "value": 1,
                        "unit": "ml"
                    }
                },
                "concentrationRatio":
                {
                    "numerator":
                    {
                        "value": 100,
                        "unit": "IU"
                    },
                    "denominator":
                    {
                        "value": 1,
                        "unit": "ml"
                    }
                }
            }]
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e806",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "SODIUMDIHYDROGENPHOSPHATEDIHYDRATE"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e826",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "WATERFORINJECTION"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e846",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "HYDROCHLORICACID"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e868",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "METACRESOL"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e888",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "SODIUMHYDROXIDE"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"Ingredient",
        "id": "Injectulin-d3e909",
        "extension":
        [{
            "url": "http://ema.europa.eu/fhir/extension/subject", 
            "valueReference":
            {
                "reference": "MedicinalProductDefinition/Injectulin-contained"
            }
        }],
        "status": "active",
        "role":
        {
            "coding":
            [{
                "system": "http://ema.europa.eu/fhir/ingredientRole",
                "code": "Inactive"
            }]
        },
        "substance":
        {
            "code":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/substance",
                        "code": "GLYCEROL"
                    }]
                }
            }
        }
    },
    {
        "resourceType":"ClinicalUseDefinition",
        "id": "Injectulin-d3e951",
        "type": "indication",
        "subject":
        [{
            "reference": "MedicinalProductDefinition/Injectulin-contained"
        }],
        "indication":
        {
            "diseaseSymptomProcedure":
            {
                "concept":
                {
                    "coding":
                    [{
                        "system": "http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure",
                        "code": "Diabetesmellitus"
                    }],
                    "text": "Diabetes mellitus where treatment with insulin is required. Injectulin is\n         also suitable for the\ntreatment of hyperglycaemic coma and ketoacidosis, as well as for\n         achieving pre-, intra- and\npost-operative stabilisation in patients with diabetes\n         mellitus."
                }
            }
        }
    },
    {
        "resourceType":"ClinicalUseDefinition",
        "id": "Injectulin-d3e965",
        "type": "indication",
        "subject":
        [{
            "reference": "MedicinalProductDefinition/Injectulin-contained"
        }],
        "indication":
        {
            "diseaseSymptomProcedure":
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                    [{
                        "system": "http://ema.europa.eu/fhir/indicationasdisease-symptom-procedure",
                        "code": "intra-andpost-operative\nstabilisation"
                    }],
                    "text": "Injectulin is also suitable for the\ntreatment of hyperglycaemic coma and\n         ketoacidosis, as well as for achieving pre-, intra- and\npost-operative stabilisation in\n         patients with diabetes mellitus."
                }
            },
            "comorbidity":
            [{
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                {
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                    [{
                        "system": "http://ema.europa.eu/fhir/comorbidity",
                        "code": "Diabetesmellitus"
                    }]
                }
            }]
        }
    },
    {
        "resourceType":"ClinicalUseDefinition",
        "id": "Injectulin-d3e982",
        "type": "indication",
        "subject":
        [{
            "reference": "MedicinalProductDefinition/Injectulin-contained"
        }],
        "indication":
        {
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                    [{
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                    "text": "Injectulin is also suitable for the\ntreatment of hyperglycaemic coma and\n         ketoacidosis, as well as for achieving pre-, intra- and\npost-operative stabilisation in\n         patients with diabetes mellitus."
                }
            }
        }
    },
    {
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                    [{
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                    }],
                    "text": "Injectulin is also suitable for the\ntreatment of hyperglycaemic coma and\n         ketoacidosis, as well as for achieving pre-, intra- and\npost-operative stabilisation in\n         patients with diabetes mellitus."
                }
            }
        }
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    "marketingStatus":
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        "dateRange":
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    "attachedDocument":
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    "masterFile":
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                "coding":
                [{
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    "operation":
    {
        "type":
        {
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            {
                "coding":
                [{
                    "system": "http://ema.europa.eu/fhir/manufacturingOperationType",
                    "code": "Batchrelease"
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            }
        },
        "effectiveDate":
        {
            "start": "2011-04-15"
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}