| 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. Default value is Application Code. 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. Based on the Sequence's Filing Type eCTD Code in
Calyx RIM, otherwise blank.
|
- new-gen
- new-nce
- new-bio
- new-rad
- new-her
- new-hea
- new-vet
- renewal
- var-type1
- var-type2
- transfer-ma
- withdrawal
- responses
- psur
|
|
| procedureType
|
string
|
Procedure Type
|
Procedure type of the submission.
|
|
|
| inventedName
|
string
|
Invented Name
|
The invented name of the Product being submitted. Multiple comma-separated values can be provided.
|
|
|
| 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. Multiple related sequence numbers may be entered as comma-separated values.
|
|
|
| submissionDescription
|
string
|
Submission Description
|
The description of the Submission to be included in the XML.
|
|
|