| country
|
string
|
Country
|
Defines which country the envelope information is related to.
|
ae, common, bh, kw, om, qa, sa, ye
|
|
| applicationNumber
|
string
|
Application Number
|
The Application Number as provided by the agency. Multiple comma-separated values can be provided.
|
|
|
| applicant
|
string
|
Applicant
|
The name of the applicant filing the submission.
|
|
|
| agencyName
|
string
|
Agency Name
|
The name of the agency that the submission is being sent to.
|
BH-MOH, KW-MOH, OM-MOH, QA-NHA, YE-MOPHP, SA-SFDA, AE-MOH
|
|
| atc
|
string
|
ATC
|
ATC code. Multiple comma-separated values can be provided.
|
|
|
| submissionType
|
string
|
Submission Type
|
The Filing type of the submission.
|
eCTD Code value from
|
|
| submissionUnitType
|
string
|
Submission Unit Type
|
The 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.
|
|
|
| procedureType
|
string
|
Procedure Type
|
Procedure type of the submission.
|
|
|
| inventedName
|
string
|
Invented Name
|
The invented name of the Product being submitted.
|
|
|
| inn
|
string
|
INN
|
The INN of the product being submitted for approval. Multiple comma-separated values can be provided.
|
|
|
| sequence
|
string
|
Sequence
|
The Sequence Number for this submission.
|
Sequence Code (without prefix "P")
|
|
| relatedSequence
|
string
|
Related Sequence
|
This is the Sequence number of a previous submission to which this submission relates.
|
|
|
| submissionDescription
|
string
|
Submission Description
|
The description of the Submission to be included in the XML. Multiple related sequence numbers may be entered as comma-separated values.
|
|
|