Calyx RIM Administration

m1-za v. 1.0

Field Name Field Type Matching UI Field Description Acceptable Values Default Value
applicationNumber string Application Number This is the number issued for the product by the MCC and remains for the full lifecycle of the product from the first data submission. Multiple comma-separated values can be provided.
applicant string Applicant The name of the applicant/HCR submitting the eCTD.
submissionType string Submission Type The type of regulatory submission that this data submission relates to. na-nce-ph, na-nce-b, na-ms, na-bs, na-le, na-cu, na-cams, pre-reg-pa, pre-reg-cl, pre-reg-pn, pre-reg-sch, pre-reg-insp, pre-reg-pa-insp, pre-reg-biol, pre-reg-cams, pre-reg-cr, post-reg-insp, post-reg-pa, post-reg-pa-insp, post-reg-cl, post-reg-pn, post-reg-pn-update, post-reg-hcr, post-reg-biol, post-reg-cams, withdrawal, cancellation
proofEfficacy map Proof of Efficacy The data type submitted as proof of efficacy and a description of the data type if "other" is selected as data type.
  • non-cl
  • cl
  • be
  • other
  • na

Example: <field name="proofEfficacy" type="map"><value key="other__uniqueSuffix__0" value="123456" /></field>

proprietaryName string Proprietary Name The name of the medicinal product. Include even if not yet approved. Multiple comma-separated values can be provided.
dosageForms string Dosage Form The dosage form of the medicinal product. Multiple comma-separated values can be provided.
inn string INN The INN of the API(s) accompanied by its salt or hydrate form (if relevant) or chemical description of the API(s). Multiple comma-separated values can be provided.
sequence string eCTD Sequence The Sequence Number for this submission. Sequence Code (without prefix "P")
relatedSequences string Related Sequence This is the sequence number of a previous submission to which this submission relates. Multiple comma-separated values can be provided.
duplicateApplications map Duplicated Applications (Proprietary Names / Application Numbers The name of the multiple / duplicate applications of the medicinal product (include even if the name is not yet approved) plus the date of application of the duplicate applications. Multiple paired values can be provided. Example: <field name="duplicateApplications" type="map"><value key="value1__uniqueSuffix__0" value="1" /></field>
supportProofDD string This field is not used for import.
supportProofText string This field is not used for import.
supportTestDD_text string This field is not used for import.
supportTestDD_text2 string This field is not used for import.