| country
|
string
|
Country
|
Defines which country the envelope information is related to.
|
|
|
| applicationNumber
|
string
|
Application Reference Number
|
Application Number as provided by the agency. Multiple comma-separated values can be provided.
|
|
|
| Identifier
|
string
|
UUID
|
A UUID, as specified by ISO/IEC 11578:1996 and ITU- T Rec X.667 | ISO/IEC 9834-8:2005, is used as the Identifier. The same UUID will be used for all sequences of an eCTD application
|
|
|
| applicant
|
string
|
Applicant
|
Name of the applicant filing the submission.
|
|
|
| mah
|
string
|
MAH
|
Name of Marketing Authorization Holder.
|
|
|
| agencyName
|
string
|
Agency
|
Name of the agency that the submission is being sent to.
|
JO-JFDA
|
|
| atc
|
string
|
ATC
|
ATC code. Multiple comma-separated values can be provided.
|
|
|
| submissionType
|
string
|
Submission Type
|
Filing type of the submission.
|
eCTD Code value from
|
|
| submissionUnitType
|
string
|
Submission Unit
|
Submission unit element of the envelope metadata set describes the content at a lower level (a "sub-activity") which is submitted in relation to a defined regulatory activity such as the applicant response to validation issues or list of questions or any other additional information.
|
initial, response, additional-info, closing, correction, reformat
|
|
| procedureType
|
string
|
Procedure
|
Procedure type of the submission.
|
|
|
| inventedName
|
string
|
Invented Name
|
Invented name of the Product being submitted.
|
|
|
| inn
|
string
|
INN
|
INN of the product being submitted for approval. Multiple comma-separated values can be provided.
|
|
|
| sequence
|
string
|
Sequence
|
Sequence Number for this submission.
|
Sequence Code (without prefix "P")
|
|
| relatedSequence
|
string
|
Related Sequence
|
Sequence number of a previous submission to which this submission relates.
|
|
|
| submissionDescription
|
string
|
Submission Description
|
Description of the Submission to be included in the XML. Multiple related sequence numbers may be entered as comma-separated values.
|
|
|
| number
|
string
|
Number
|
Reference number of the product allocated by the regulatory authority. If the number is not yet allocated at the time point of submission, 'to be advised' should be added instead and replaced by the number in follow-up submissions when registered.
|
|
|