| country
|
string
|
Country
|
Defines which country the envelope information is related to.
|
hr
|
|
| applicationNumber
|
string
|
Application Tracking Number
|
The Application Number as provided by the agency.
|
|
|
| applicant
|
string
|
Applicant
|
The name of the company submitting the Application.
|
|
|
| agencyName
|
string
|
Agency Name
|
The name of the agency that the submission is being sent to.
|
|
|
| submissionType
|
string
|
Submission Type
|
The Filing type of the submission. Based on the Sequence's Filing Type eCTD Code in
Calyx RIM, otherwise blank.
|
- initial-maa
- supplemental-info
- fum
- specific-obligation
- var-type1a
- var-type1b
- var-type2
- extension
- psur
- renewal
- asmf
- pmf
- referral
- annual-reassessment
- usr
- article-58
- notification-61-3
- transfer-ma
- corrigendum
- lifting-suspension
- withdrawal
- paed-article-29
- paed-article-46
- var-nat
- reformat
|
|
| submissionMode
|
string
|
Submission Mode
|
The mode of the submission, either Single, Grouping, or Worksharing.
|
- single
- grouping
- worksharing
|
|
| highLevelSubmissionNumber
|
string
|
High Level Submission Number
|
The high level submission number for the specific submission, used when the submission mode is grouping or worksharing.
|
|
|
| procedureType
|
string
|
Procedure Type
|
The procedure type being used to submit. Based on the Application's Procedure Type.
|
- centralised
- national
- mutual-recognition
- decentralised
|
national
|
| inventedName
|
string
|
Invented Name
|
The invented name of the product being submitted for approval.
|
|
|
| inn
|
string
|
INN
|
The INN of the product being submitted for approval.
|
|
|
| sequence
|
string
|
Sequence
|
The Sequence Number for this submission.
|
Sequence Code (without prefix "P")
|
|
| relatedSequence
|
string
|
Related Sequence
|
The related sequence number as well as the country for the specific relation. Country values include all of Europe, Common and EMEA
|
|
|
| submissionDescription
|
string
|
Submission Description
|
The description of the Submission to be included in the XML.
|
|
|