| agencyName
|
string
|
Agency Name
|
The name of the agency that the submission is being sent to. Defaults based on the Application's Country.
|
AT-AGES, BE-FAMHP, BG-BDA, BG-NVS, CY-VS, CZ-SUKL, CZ-USKVBL, DE-BFARM, DE-BVL, DE-PEI, DK-DKMA, EE-SAM, EL-EOF, ES-AGEMED, FI-NAM, FR-AFSSAPS, FR-ANMV, HU-IVMP, HU-OGYI, IE-IMB, IE-DAFF, IS-IMCA, IT-AIFA, IT-LMV, IT-SPV, LI-LLV, LT-SMCA, LT-VVPI, LT-VMVT, LU-MINSANT, LV-ZVA, MT-MRU, MT-MEDAUTH, NL-MEB, NO-NOMA, PL-URPL, PT-DGV, PT-INFARMED, RO-ANM, SE-MPA, SI-JAZMP, SK-SIDC, SK-USKVBL, UK-MHRA, UK-VMD, EU-EMEA
|
|
| applicant
|
string
|
Applicant
|
The name of the company submitting the Application.
|
|
|
| applicationNumber
|
string
|
Application Number
|
The Application Number as provided by the agency.
|
|
|
| atc
|
string
|
ATC
|
The ATC of the Product being submitted.
|
|
|
| country
|
string
|
Country
|
Defines which country the envelope information is related to. Defaults based on the Application's Country. Show all EU countries, plus EMEA and Common.
|
at, be, bg, cy, cz, de, dk, ee, el, emea, es, fi, fr, hu, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk
|
|
| inn
|
string
|
INN
|
The INN of the product being submitted for approval.
|
|
|
| inventedName
|
string
|
Invented Name
|
The invented name of the product being submitted for approval.
|
|
|
| procedureType
|
string
|
Procedure Type
|
The procedure type being used to submit. Based on the Application's Procedure Type.
|
- centralised
- national
- mutual-recognition
|
|
| 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.
|
|
|
| sequence
|
string
|
Sequence
|
The Sequence Number for this submission.
|
Sequence Code (without prefix "P")
|
|
| 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
- referral
- annual-reassessment
- usr
- article-58
- notification-61-3
- transfer-ma,
- corrigendum
- lifting-suspension
- withdrawal
- paed-article-29
- var-nat
- reformat
|
|
| submissionDescription
|
string
|
Submission Description
|
The description of the Submission to be included in the XML.
|
|
|