Calyx RIM Administration

m1-th v. 1.0

Field Name Field Type Matching UI Field Description Acceptable Values Default Value
esubId string eSubmission Identifier The Application Number as provided by the agency. Application Code. The value should consist of the small EN letter and 7 digits ([a-z]([0-9]{7}))
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 Data Administration > Filing Type Values > Filing Type eCTD Code
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
  • Cosmetic
  • Medical-Devices
licenseeNumber string Licensee Number The licensee number of the company that is legally responsible for the application in Thailand.
licenseeType string Licensee Type The licensee type of Licensee Number for the application in Thailand. The licensee type of the company should be provided.
  • Importer
  • Manufacturer
licensee string Licensee Name The licensee name that is legally responsible for the application in Thailand. The licensee name of the company should be provided in all capital letters.
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.
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.
sequence string Sequence Number The Sequence Number for this submission. Sequence Code (without prefix "P")
relatedSequence string Related Sequence Number Four digit sequence number used for supplementary information indicating the initial sequence number of the regulatory activity.
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.
email string Contact Email The email is used to notify the applicant in case of change in application status. Must be valid email format. Example: [email protected]