Calyx RIM Administration

envelope v. 3.0.1

Field Name Field Type Matching UI Field Description Acceptable Values Default Value
country string Country Defines which country the envelope information is related to. Defaults based on the Application’s Country. Show all EU countries, plus EMA and EDQM. at, be, bg, cy, cz, de, dk, ee, edqm, el, ema, es, fi, fr, hu, hr, ie, is, it, li, lt, lu, lv, mt, nl, no, pl, pt, ro, se, si, sk, uk
uuid string UUID A UUID as specified by ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005. The same UUID must be used for all sequences of an eCTD application. Defaults based on the UUID from the parent Application. The UUID must be in the form of xxxxxxxx-xxxx-Mxxx-Nxxx-xxxxxxxxxxxx,
where:
  • x is a hexadecimal number
  • M is 1-5
  • N is 8, 9, a or b
submissionType string Submission Type The Filing type of the submission. Based on the Sequence's Filing Type eCTD Code in Calyx RIM, otherwise blank. eCTD Code value from Data Administration > Filing Type Values > Filing Type eCTD Code
submissionMode string Submission Mode The mode of the submission, either Single, Grouping, or Worksharing.
  • single
  • grouping
  • worksharing
highLevelSubmissionNumber string High Level/Worksharing Submission Number The high level submission number for the specific submission, used when the submission mode is Grouping or Worksharing.
applicationNumber string Application Tracking Number The Application Number as provided by the agency. Multiple comma-separated values can be provided.
submissionUnit string Submission Unit Type Submission unit type describes the content at a lower level (a “sub-activity”) which is submitted in relation to a defined regulatory activity.
  • initial
  • validation-response
  • response
  • additional-info
  • closing
  • consolidating
  • corrigendum
  • reformat
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. Based on Application's Country. AT-BASG, BE-FAMHP, BG-BDA, CY-PHS, CZ-SUKL, DE-BFARM, DE-PEI, DK-DKMA, EE-SAM, EL-EOF, ES-AEMPS, FI-FIMEA, FR-ANSM, HR-HALMED, HU-OGYI, IE-HPRA, IS-IMCA, IT-AIFA, LI-LLV, LT-SMCA, LU-MINSANT, LV-ZVA, MT-MEDAUTH, NL-MEB, NO-NOMA, PL-URPL, PT-INFARMED, RO-ANMMD, SE-MPA, SI-JAZMP, SK-SIDC, UK-MHRA, EU-EMA, EU-EDQM
procedureType string Procedure Type The procedure type being used to submit. Based on the Application's Procedure Type.
  • centralised
  • national
  • mutual-recognition
  • decentralised
inventedName string Invented Name The invented name of the product being submitted for approval. 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 previous submission(s) to which this submission relates, e.g. the responses to questions to a particular variation. If value of submissionUnit field is ‘initial’ and ‘reformat’ then value of relatedSequence field is identical to the value of sequence field. Multiple comma-separated values can be provided.
submissionDescription string Submission Description The description of the Submission to be included in the XML.