| esubId
|
string
|
eSubmission Identifier
|
The Application Number as provided by the agency. Default value is Application Code. The entered values should be validated before saving.
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| sequenceType
|
string
|
Sequence Type
|
Identifies the type of activity that is being submitted with the sequence. If it is the first sequence then submit the regulatory activity type. If it is the second, third, etc. sequences then submit supplementary information. The value used in the XML should be taken from that matching eCTD Code.
|
eCTD Code value from
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| regActivityLead
|
string
|
Regulatory Activity Lead
|
Identifies the group within the THAI FDA, which is expected to take the lead in the review process.
|
- Biologicals
- Pharmaceuticals
- Pharmacovigilance
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| licensee
|
string
|
Licensee
|
The licensee name that is legally responsible for the application in Thailand. The official registered name of the company should be provided.
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| inn
|
string
|
INN/Generic Name
|
The INN or Generic Name of the active ingredients used in the product. Multiple comma-separated values can be provided.
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| productName
|
string
|
Product Name
|
The name or proposed product (trade) name(s) to be used on the Certificate of Registration. If duplicate products are being submitted within one application, all products should be listed. Multiple comma-separated values can be provided.
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| sequence
|
string
|
Sequence Number
|
The Sequence Number for this submission.
|
Sequence Code (without prefix "P")
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| relatedSequence
|
string
|
Related Sequence Number
|
Four digit sequence number used for supplementary information indicating the initial sequence number of the regulatory activity (without prefix "P").
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| seqDescription
|
string
|
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.
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