eCTD Attributes Thailand
Thailand-v0.92
| Attribute | Description |
|---|---|
| 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. |
| Licensee | The licensee name that is legally responsible 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. |
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. |
| 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. |
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