Thailand-v1.0
| Attribute | Description |
| Contact Email | The email address used to notify the applicant of a change in application status. |
|
eSubmission Identifier |
The Application Number as provided by the agency. |
| INN/Generic Name | The INN or Generic Name of the active ingredients used in the product. Multiple comma-separated values can be provided. |
| Attribute | Description |
| Licensee Name | The licensee name that is legally responsible for the application in Thailand. |
| Licensee Number | The licensee number of the company that is legally responsible for the application in Thailand. |
| Licensee Type | The licensee type of Licensee Number for the application in Thailand. |
| Product Name | The name or proposed product (trade) name to be used on the Certificate of Registration. Multiple comma-separated values can be provided. |
|
Regulatory Activity Lead |
Identifies the group within the THAI FDA which is expected to take the lead in the review process. |
|
Related Sequence Number |
Four digit sequence number used for supplementary information indicating the initial sequence number of the regulatory activity. |
| Sequence Description | Free text description of the submission. The description provided here should also be used in the node title for 1.0 Cover Letter and 1.R Response to Questions. |
| Sequence Number | Four digit sequence number matching the sequence folder being submitted. |
| Sequence Type | Identifies the type of activity that is being submitted with the sequence, either the regulatory activity type if it is the first sequence of the regulatory activity or supplementary information if it is a follow-up to information already submitted for the regulatory activity. |
eCTD Attributes Ukraine
List of eCTD attributes and their description used for a submission.
Ukraine-v1.0
| Attribute | Description |
| Country | Unique country code for Ukraine (ua) |
| 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 type of regulatory activity to which the content will be submitted. |
| Submission Mode | The high-level handling of the information submitted as part of variation(s) and extension applications. The mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity. |
| Submission Unit Type | Submission unit type describes the content at a lower level (a "sub activity") which is submitted in relation to a defined regulatory activity. |
| Attribute | Description |
| Submission Number | This number is used by regulatory authority to track the submission, in any procedure, in relation to a particular medicinal product. This is the number of the registration form or package of registration forms. |
| Applicant | The name of the company submitting the Application. |
| Agency Name | Regulatory authority which is The State Expert Center of MOH of Ukraine. |
| Procedure Type | The type of procedure for the submission. |
| Invented Name | The name of the medicinal product. |
| INN | International Non-proprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. A non-proprietary name is also known as a generic name. |
| Sequence | This is the sequence number of the submission - this should start at 0000 for the initial submission, and then increase incrementally with each subsequent submission related to the same medicinal product. |
| Related Sequence | This is the sequence number of previous submission to which this submission relates e.g. the responses to questions to a particular variation. |
| Submission Description | This element is used to provide a short text description of the submission. |
eCTD Attributes United States
You can use the following attributes to describe eCTD submissions for the United States.