European Union-v3.1
| Attribute | Description |
| Country | Defines which country the envelope information is related to. |
| UUID | A UUID as specified by ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005. The same UUID must be used for all sequences of an eCTD application. |
| Submission Type | The Filing type of the submission. |
| Submission Mode | The mode of the submission, either single, grouping, or worksharing. |
| Submission Unit Type | Submission unit type describes the content at a lower level (a "subactivity") which is submitted in relation to a defined regulatory activity. |
|
High Level/ Worksharing Submission Number |
The high level submission number for the specific submission, used when the submission mode is grouping or worksharing. |
|
Application Tracking Number |
The Application Number as provided by the agency. |
| Applicant | The name of the company submitting the application. |
| Agency Name | The name of the agency that the submission is being sent to. |
| Procedure Type | The procedure type being used to submit. |
| Attribute | Description |
| Invented Name | The invented name of the product being submitted for approval. |
| INN | The INN of the product being submitted for approval. |
| Sequence | The Sequence Number for this submission. |
| Related Sequence | This is the sequence number of previous submission(s) to which this submission relates. For example, the responses to questions to a particular variation. In the case of submission unit types 'initial' and 'reformat' related sequence is identical to the sequence number. |
| Submission Description | The description of the Submission to be included in the XML. |