{ "$schema": "http://json-schema.org/draft-07/schema#", "$id": "https://dscsagovernance.org/dscsa-exception-notification-message-schemas/pdg-dscsa-exception-notification-draft-v1.0.1.json", "title": "PDG DSCSA TI Exception Notification Schema", "description": "Defines notifications of TI exceptions.", "type": "object", "properties": { "exceptionNotification": { "properties": { "exceptionNotificationSchemaOrTemplateVersion": { "$ref": "#/definitions/schemaVersionType", "$comment": "This is the JSON schema version. Please check https://dscsagovernance.org/ to ensure you are using the latest version of this schema." }, "dscsaCredentialPresentation": { "$ref": "#/definitions/dscsaCredentialPresentationType", "$comment": "A Presentation of the Notifier's ATP or ATP Equivalent Credential." }, "notifyingOrganizationInformation": { "type": "object", "required": [ "contactInformation", "notifyingOrganizationName" ], "properties": { "notifyingOrganizationName": { "type": "string", "$comment": "The name of the organization making the exception notification." }, "contactInformation": { "$ref": "#/definitions/contactInformationType", "$comment": "Information to aid the notified party in contacting the notifying party regarding the notification" }, "notifyingPartyGLN": { "$ref": "#/definitions/glnType", "$comment": "The Global Location Number (GLN) of the Organization making the Notification." } }, "$comment": "Provide contact information to allow the Seller to follow up with a resolution or questions." }, "notifiedOrganizationInformation": { "type": "object", "properties": { "notifiedOrganizationName": { "type": "string", "$comment": "The name of the organization being notified of an exception." }, "notifiedPartyGLN": { "$ref": "#/definitions/glnType", "$comment": "The Global Location Number (GLN) of the Organization being Notified of the exception." } }, "required": ["notifiedOrganizationName"] }, "references": { "type": "object", "properties": { "notificationID": { "$ref": "#/definitions/uuidType", "$comment": "This is a unique ID you have assigned to this notification. The receiver of the notification can reference this ID in communications." }, "timestamp": { "$ref": "#/definitions/timestampType", "$comment": "The date and time the notification was created. " }, "incidentID": { "type": "string", "$comment": "This is a unique ID the Notifier has assigned to the Incident. The receiver of the notification can reference this ID in communications. " }, "shipmentID": { "type": "string", "$comment": "The Shipment ID from the shipment papers." }, "purchaseOrderList": { "type": "array", "$comment": "The Purchase Order Number(s) associated with the shipment.", "items": {"$ref": "#/definitions/purchaseOrderType"} }, "shipmentReceiptDate": { "$ref": "#/definitions/dateType", "$comment": "The date the shipment was received by the Buyer. " }, "carrierTrackingNumber": { "type": "string", "$comment": "The tracking number assigned by the carrier." }, "exceptionLocation": { "$comment": "The location in the Notifier's operation where the exception was first identified (receiving, picking, etc).", "$ref": "#/definitions/exceptionLocationType" }, "receivingLocationGLN": { "$ref": "#/definitions/glnType", "$comment": "The Global Location Number (GLN) of the receiving location." }, "receivingLocationName": {"type": "string"}, "receivingLocationAddress": { "$comment": "The street address of the receiving location.", "$ref": "#/definitions/addressType" } }, "if": { "properties": { "exceptionLocation": {"const": "Other"} } }, "then": { "properties": { "exceptionLocationOther": {"type": "string"} }, "required": ["exceptionLocationOther"] }, "required": [ "notificationID", "timestamp" ], "$comment": "Key information associated with the shipment and Exception Notification." }, "exceptions": { "type": "array", "items": { "type": "object", "$comment": "repeats for each exception.", "properties": { "exceptionLineNumber": { "type": "integer", "$comment": "Used for reference between the Notifier and the organization receiving the notification." }, "exceptionDescription": { "$ref": "#/definitions/exceptionDescriptionType", "$comment": "A short description of the exception(s) you have observed." }, "buyerResolutionRequests": { "type": "array", "items": { "properties": { "buyerResolutionRequest": { "$ref": "#/definitions/buyerResolutionRequestType", "$comment": "Used if the notifying party is the Buyer. This is a prefered resolution outcome of the Buyer. Standard choices are provided in the enum list." } }, "if": { "properties": { "buyerResolutionRequest": {"const": "Other"} } }, "then": { "properties": { "buyerResolutionRequestOther": {"type": "string"} }, "required": ["buyerResolutionRequestOther"] } }, "$comment": "Used if the notifying party is the Buyer. These are the prefered resolution outcome(s) of the Buyer. Standard choices are provided in the enum list." }, "buyerActionTaken": { "$ref": "#/definitions/buyerActionTakenType", "$comment": "Used if the notifying party is the Buyer. This is the action that the Buyer has already taken due to the exception. Standard choices are provided in the enum list." }, "sellerResolutionRequests": { "type": "array", "items": { "properties": { "sellerResolutionRequest": { "$ref": "#/definitions/sellerResolutionRequestType", "$comment": "Used if the notifying party is the Seller. This is a prefered resolution outcome of the Seller. Standard choices are provided in the enum list." } }, "if": { "properties": { "sellerResolutionRequest": {"const": "Other"} } }, "then": { "properties": { "sellerResolutionRequestOther": {"type": "string"} }, "required": ["sellerResolutionRequestOther"] } }, "$comment": "Used if the notifying party is the Seller. These are the prefered resolution outcome(s) of the Seller. Standard choices are provided in the enum list." }, "sellerActionTaken": { "$ref": "#/definitions/sellerActionTakenType", "$comment": "Used if the notifying party is the Seller. This is the action that the Seller has already taken due to the exception. Standard choices are provided in the enum list." }, "exceptionAppliesTo": { "$ref": "#/definitions/exceptionAppliesToType", "$comment": "This exception applies to either the entire shipment or certain products in the shipment. Standard choices are provided in the enum list." }, "exceptionPriority": { "$ref": "#/definitions/exceptionPriorityType", "$comment": "The priority the notifier has assigned to this notification. Standard choices are provided in the enum list." }, "exceptionStatus": { "$ref": "#/definitions/exceptionStatusType", "$comment": "The status the notifier has assigned to this notification. Standard choices are provided in the enum list." }, "exceptionCategoryList": { "type": "array", "items": { "properties": { "exceptionCategory": { "$ref": "#/definitions/exceptionCategoryType", "$comment": "The category the notifier has assigned to this notification. Standard choices are provided in the enum list." } }, "if": { "properties": { "exceptionCategory": {"const": "Other"} } }, "then": { "properties": { "exceptionCategoryOther": {"type": "string"} }, "required": ["exceptionCategoryOther"] } }, "$comment": "The categories the notifier has assigned to this notification. Standard choices are provided in the enum list." }, "exceptionTypeList": { "type": "array", "items": { "properties": { "exceptionType": { "$ref": "#/definitions/exceptionTypeType", "$comment": "An exception type the notifier has assigned to this notification (usually a further refinement of the category). Standard choices are provided in the enum list." } }, "if": { "properties": { "exceptionType": {"const": "Other"} } }, "then": { "properties": { "exceptionTypeOther": {"type": "string"} }, "required": ["exceptionTypeOther"] } }, "$comment": "The exception type(s) the notifier has assigned to this notification (usually a further refinement of the category). Standard choices are provided in the enum list." }, "InformationOnPhysicalProduct": { "type": "object", "properties": { "sscc": { "type": "string", "$comment": "The Serial Shipping Container Code (SSCC) found in the Transaction Information (TI) sent by the Seller." }, "drugProductInformation": { "$ref": "#/definitions/drugProductType", "$comment": "Information about the drug product (master data)." }, "physicalProductNotes": { "type": "string", "$comment": "Any additional notes about the physical product or packaging." } }, "$comment": "These fields apply to the physical product in the shipment. This data is found on the product itself. " }, "InformationReceivedOrSent": { "type": "object", "properties": { "sscc": { "type": "string", "$comment": "The Serial Shipping Container Code (SSCC) found in the Transaction Information (TI) sent by the Seller." }, "drugProductInformation": { "$ref": "#/definitions/drugProductType", "$comment": "Information provided by the Seller in the Transaction Information." }, "dataNotes": { "type": "string", "$comment": "Any additional notes about the Transaction Information or Transaction Statement." } }, "$comment": "These fields apply to the date in the Transaction Information (TI) or Transaction Statement (TS) associated with the shipment." } }, "allOf": [ { "if": { "properties": { "buyerActionTaken": {"const": "Other"} } }, "then": { "properties": { "buyerActionTakenOther": {"type": "string"} }, "required": ["buyerActionTakenOther"] } }, { "if": { "properties": { "sellerActionTaken": {"const": "Other"} }, "required": ["sellerActionTaken"] }, "then": { "required": ["sellerActionTakenOther"] } }, { "if": { "properties": { "exceptionAppliesTo": {"const": "Other"} } }, "then": { "properties": { "exceptionAppliesToOther": {"type": "string"} }, "required": ["exceptionAppliesToOther"] } }, { "if": { "properties": { "exceptionPriority": {"const": "Other"} } }, "then": { "properties": { "exceptionPriorityOther": {"type": "string"} }, "required": ["exceptionPriorityOther"] } }, { "if": { "properties": { "exceptionStatus": {"const": "Other"} } }, "then": { "properties": { "exceptionStatusOther": {"type": "string"} }, "required": ["exceptionStatusOther"] } } ], "required": [] }, "minItems": 1, "$comment": "Documentation of the issues observed by the Notifier about the shipment, product, or information provided by the Seller." }, "exceptionAdditionalInformation": { "type": "object", "properties": { "additionalInformationLinkList": { "type": "array", "items": { "properties": { "additionalInformationLink": {"$ref": "#/definitions/additionalInformationLinkType"} } }, "$comment": "List the addresses to documents or files that are related to this notification." }, "additionalInformationBase64List": { "type": "array", "items": { "properties": { "additionalInformationBase64": {"$ref": "#/definitions/additionalInformationBase64Type"} } }, "$comment": "Documents or files encoded in Base 64 associated with this notification." } }, "$comment": "Additional documents or images sent or available concerning this Exception Notification." } }, "type": "object", "required": [ "exceptionNotificationSchemaOrTemplateVersion", "references", "exceptions", "notifyingOrganizationInformation", "notifiedOrganizationInformation" ], "$comment": "The primary container for all exception-related data, including actions taken by the buyer and seller, product details, and status of the exception." } }, "definitions": { "additionalInformationBase64Type": { "type": "string", "contentEncoding": "base64", "description": "This property can hold base64 encoded data of various image and document formats (e.g., PNG, JPG, PDF).", "$comment": "Documents or files encoded in Base 64 associated with this notification.", "pattern": "^[A-Za-z0-9+/]+={0,2}$" }, "additionalInformationLinkType": { "type": "string", "format": "uri", "$comment": "List the addresses to documents or files that are related to this notification." }, "addressType": { "type": "object", "properties": { "streetAddressLine1": { "type": "string", "pattern": "^[0-9a-zA-Z ]*$", "$comment": "Represents the name of the street or road." }, "streetAddressLine2": { "type": "string", "pattern": "^[0-9a-zA-Z ]*$", "$comment": "Optional additional address information" }, "city": { "type": "string", "$comment": "The name of the town or city. If overseas military location, use \"APO\", \"FPO\", \"DPO\"", "pattern": "^[A-Za-z .'\\\\-]+$" }, "stateProvinceOrRegion": { "anyOf": [ { "enum": [ "AL", "AK", "AZ", "AR", "CA", "CO", "CT", "DE", "FL", "GA", "HI", "ID", "IL", "IN", "IA", "KS", "KY", "LA", "ME", "MD", "MA", "MI", "MN", "MS", "MO", "MT", "NE", "NV", "NH", "NJ", "NM", "NY", "NC", "ND", "OH", "OK", "OR", "PA", "RI", "SC", "SD", "TN", "TX", "UT", "VT", "VA", "WA", "WV", "WI", "WY", "DC", "AS", "GU", "MP", "PR", "VI", "UM", "AA", "AE", "AP" ] }, {"type": "string"} ], "$comment": "The state, province, or region using the standard two-letter abbreviation specified in ISO 3166-2:1998 country subdivision code." }, "postalCode": { "type": "string", "$comment": "Alphanumeric code assigned by postal authorities for sorting and delivering mail." }, "countryCode": { "type": "string", "$comment": "The country using the standard two-letter abbreviation specified in ISO 3166-1 alpha-2 list of 2-letter country codes.", "maxLength": 2, "minLength": 2 } }, "required": [ "streetAddressLine1", "city", "stateProvinceOrRegion", "postalCode", "countryCode" ] }, "buyerActionTakenType": { "type": "string", "enum": [ "Product has been returned", "Shipment has been refused" ] }, "buyerResolutionRequestType": { "type": "string", "enum": [ "Send Corrected Data", "Send Product", "Return Product", "Credit Account", "Debit Account" ], "$comment": "Used if the notifying party is the Buyer. This is a prefered resolution outcome of the Buyer. Standard choices are provided in the enum list." }, "contactInformationType": { "properties": { "personOrDepartmentName": { "$ref": "#/definitions/nameValueType", "$comment": "The person or Department that can be contacted regarding the Exception Notification." }, "organizationName": { "$ref": "#/definitions/nameValueType", "$comment": "Name of organization sending the Notification." }, "phone": { "$ref": "#/definitions/phoneType", "$comment": "The phone number of the Notifying party." }, "email": { "$ref": "#/definitions/emailType", "$comment": "The email address of the Notifying party." } }, "type": "object", "required": [ "personOrDepartmentName", "organizationName", "phone", "email" ], "$comment": "Information to aid the Requester or Responder in contacting the other party in regard to the Request or Response." }, "dateType": { "type": "string", "maxLength": 10, "minLength": 10, "pattern": "^\\d{4}-\\d{2}-\\d{2}$", "format": "date" }, "drugProductType": { "type": "object", "properties": { "gtin": { "type": "string", "$comment": "The Global Trade Item Number (GTIN) found on the product label, in the product Data Matrix barcode or in the Transaction Information." }, "ndc": { "type": "string", "$comment": "The National Drug Code (NDC) found on the product label or in the Transaction Information." }, "drugName": { "type": "string", "$comment": "The Drug Name found on the product label or in the Transaction Information." }, "lotNumber": { "type": "string", "$comment": "The Lot Number found on the product label or in the Transaction Information." }, "expirationDate": { "type": "string", "$comment": "The Expiration Date found on the product label or in the Transaction Information." }, "serialNumberList": { "type": "array", "items": { "properties": { "serialNumber": { "type": "string", "$comment": "A Serial Number found on the product label, product Data Matrix barcode or Transaction Information." }, "barcodeScan": { "type": "string", "$comment": "The barcode scan of the Data Matrix barcode on the product label associated with the gtin, lotNumber expirationDate and serialNumber combination (Product Identifier)." } } }, "$comment": "The Serial Number(s) found on the product label(s), the product Data Matrix barcode(s) or Transaction Information record(s)." } } }, "dscsaCredentialPresentationType": { "type": "object", "properties": { "dscsaATPCredentialPresentation": { "type": "string", "format": "jwt", "$comment": "A W3C standard verifiable credential conformant to the OCI DSCSA ATP Credential specification." }, "dscsaATP-EquivalentCredentialPresentation": { "type": "string", "format": "jwt", "$comment": "A W3C standard verifiable credential conformant with the OCI DSCSA ATP Equivalent Credential specification." }, "dscsaAuthorityCredentialPresentation": { "type": "string", "format": "jwt", "$comment": "A W3C standard verifiable credential conformant with the OCI DSCSA Authority Credential specification." } }, "oneOf": [ { "required": ["dscsaATPCredentialPresentation"] }, { "required": ["dscsaATP-EquivalentCredentialPresentation"] }, { "required": ["dscsaAuthorityCredentialPresentation"] } ], "$comment": "Requester or Responder signed presentation of an ATP, ATP-Equivalent or DSCSA Authority credential. See latest OCI Schema Version." }, "emailType": { "type": "string", "format": "email" }, "exceptionAppliesToType": { "type": "string", "enum": [ "Entire Shipment", "Items in Shipment" ], "$comment": "This exception applies to either the entire shipment or certain products in the shipment. Standard choices are provided in the enum list." }, "exceptionCategoryType": { "type": "string", "enum": [ "Data Issue", "Damaged Product", "Product No Data", "Data No Product", "Packaging and Labeling", "Other" ], "$comment": "The category the notifier has assigned to this notification. Standard choices are provided in the enum list." }, "exceptionDescriptionType": {"type": "string"}, "exceptionLocationType": { "type": "string", "enum": [ "Receiving", "Outbound Picking", "Returns Processing", "Reconciliation", "Other" ] }, "exceptionPriorityType": { "type": "string", "enum": [ "High", "Medium", "Low" ], "$comment": "The priority the notifier has assigned to this notification. Standard choices are provided in the enum list." }, "exceptionStatusType": { "type": "string", "enum": [ "Open", "In Progress", "In Review", "Pending Response", "Cancelled", "Resolved", "Closed" ], "$comment": "The status the notifier has assigned to this notification. Standard choices are provided in the enum list." }, "exceptionTypeType": { "type": "string", "$comment": "An exception type the notifier has assigned to this notification (usually a further refinement of the category). Standard choices are provided in the enum list.", "enum": [ "Barcode Reading Issue", "Barcode Encoding Issue", "Certificate Issue", "Duplicate EPCIS Events", "EPCIS Event Formatting Issue", "EPCIS Event Timestamp Sequence", "Missing Attributes", "Missing EPCIS Events", "Unrecognized Buyer GCP and/or GLN", "Unrecognized Seller GCP and/or GLN", "Unrecognized Product Information", "Unrecognized Seller", "Unrecognized Buyer", "Unrecognized P.O. #", "Other" ] }, "glnType": { "type": "string", "minLength": 13, "pattern": "^\\d{13}$", "maxLength": 13, "$comment": "The GS1 Global Location Number (GLN) as recorded in the TI record. See Implementation Guideline: Applying GS1 Standards for DSCSA and Traceability." }, "nameValueType": { "type": "string", "pattern": "^[\\p{L}\\s.'-]+$" }, "phoneType": { "type": "string", "$comment": "The phone number of the Requester or Responder." }, "purchaseOrderType": {"type": "string"}, "sellerActionTakenType": { "type": "string", "enum": [ "Credit Applied", "RMA Sent", "Other" ], "$comment": "Used if the notifying party is the Seller. This is the action that the Seller has already taken due to the exception. Standard choices are provided in the enum list." }, "sellerResolutionRequestType": { "type": "string", "enum": ["Send Back Product"] }, "schemaVersionType": { "type": "string", "description": "Exception Notification Schema Version. ", "default": "1.0.1", "pattern": "^[0-9]{1}.[0-9]{1}.[0-9]{1}$" }, "timestampType": { "$comment": "A timestamp to millisecond precision, with an explicit timezone indicator (+/‐hh:mm) relative to UTC Use 00 for miliseconds if you are unable to be percise at that level.", "type": "string", "pattern": "^\\d{4}-\\d{2}-\\d{2}T\\d{2}:\\d{2}:\\d{2}(?:\\.\\d+)?(Z|[+-]\\d{2}:\\d{2})$", "format": "date-time" }, "uuidType": { "type": "string", "pattern": "^[a-fA-F\\d]{8}-[a-fA-F\\d]{4}-4[a-fA-F\\d]{3}-[89abAB][a-fA-F\\d]{3}-[a-fA-F\\d]{12}$", "$comment": "Universally Unique Identifier (UUID)" } }, "required": ["exceptionNotification"], "$comment": "This JSON Schema defines the structure for managing DSCSA exception notifications within the pharmaceutical supply chain. It helps ensure data consistency and validation across all parties involved in an exception." }