eaeu_leaf v. 1.0
| Field Name | Field Type | Matching UI Field | Description | Acceptable Values | Default Value |
|---|---|---|---|---|---|
| registrationFileIndicator | string | Registration File Indicator | Defines if element belongs to a registration dossier or a drug master file. | true/false | true |
| drugRegistrationDocCode | string | Drug Registration Document Code | Defines a purpose of the leaf in the output, according to the assembly template. | Five digits, according to classifier. | |
| drugRegistrationDocumentName | string | Drug Registration Document Name | Name is specified if Drug Registration Document Code is not specified or there is no appropriate code in the classifier. | ||
| drugRegistrationFileCodeSection | string | Drug Registration File Section | Helps to sort out value from Drug Registration File Code list. | Two digits | |
| drugRegistrationFileCode | string | Drug Registration File Code | Defines the Drug Registration File Code value. | Four digits | |
| drugRegistrationFileName | string | Drug Registration File Name | Name is specified if Drug Registration File Code is not specified or there is no appropriate code in the classifier. | ||
| docCreationDate | date | Document Creation Date | Date of document creation. | Date format - Unix Timestamp.
If empty, this message appears: "Document Creation Date is required" message is displayed. If the entered data cannot be recognized as a date, "Invalid date specified". |
|
| docValidityDate | date | Document Validity Date | Date when document expires. | Date format - Unix Timestamp.
If entered data cannot be recognized as a date, this message appears: "Invalid date specified". |
|
| businessEntityName | string | Business Entity Name | Organization name issued registration dossier. | ||
| drugAttributeText01 | date | Request Response Date | Response to request must be provided before specified date. | Date format - Unix Timestamp. If entered data cannot be recognized as a date, this message appears: "Invalid date specified". | |
| drugAttributeText02 | string | Reason Document Number | Reason Document Number. | ||
| drugAttributeText03Section | string | Requested Drug Registration File Section | Helps to sort out value from Drug Registration File Code list . | Two digits | |
| drugAttributeText03Code | string | Requested Drug Registration File Code | Defines Drug Registration File Code value. | Four digits | |
| drugAttributeText04 | string | Requested Drug Registration Document Code | Code that defines purpose of the leaf in the output, according to assembly template. | Five digits, according to classifier | |
| drugAttributeTexts99 | string | Other Information | User may add several text boxes using the Add button. | ||
| drugAttributeTextName | string | General Information | Defines general information. |