envelope v. 1.0

Field Name Field Type Matching UI Field Description Acceptable Values Default Value
agencyName string Agency Name The name of the agency that the submission is being sent to. Defaults based on the Application's Country.
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, common, 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 map Related Sequence The related sequence number as well as the country for the specific relation. Country values include all of Europe, Common, and EMEA. Example: <field name="relatedSequence" type="map"><value key="emea" value="1234" /></field>
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.
  • arbitration
  • cond-specific-obligation
  • dmf
  • follow-up
  • initial-maa
  • psur
  • renewal
  • safety
  • sepcific-obligation
  • supplemental-info
  • var-type1a
  • var-type1b
  • var-type2
submissionDescription string Submission Description The description of the Submission to be included in the XML.