Classes of documents related to the Marketed Substance Stability


The following classes of documents related to the Marketed Substance Stability are appropriate as a basis for change for a Marketed Substance - Production Chain entity:

  • Confirmation of stability studies protocol as per B.I.d.1#2 req.
    the automatically assigned file name "vbId1-2-confirm-stability-studies-protocol-substprodchain.pdf"
  • Justification for the proposed changes as per B.I.d.1#4 req.
    the automatically assigned file name "vbId1-4-justif-proposed-changes-substprodchain.pdf"
  • Retest period change - as per B.I.d.1 type ll req.
    the automatically assigned file name "vbid1-retest-period-change-type-ll-var.pdf"
  • Storage period change - as per B.I.d.1 type ll req.
    the automatically assigned file name "vbid1-storage-period-change-type-ll-var.pdf"
  • Storage condition change - as per B.I.d.1 type ll req.
    the automatically assigned file name "vbid1-storage condition-change-type-ll-var.pdf"