Classes of documents related to the Marketed Substance Design Space


related to the Marketed Substance Design Space are appropriate as a basis for change for a Marketed Substance - Production Chain entity:

  • Design space development as per B.I.e.1#1 req.
    the automatically assigned file name "vbIe1-1-design-space-development-substprodchain.pdf"
  • Design space description as per B.I.e.1#2 req.
    the automatically assigned file name "vbIe1-2-design-space-description-substprodchain.pdf"
  •  Detailed description for the proposed change as per B.I.e.2#1 req.
    the automatically assigned file name "vbIe2-1-description-proposed-change-substprodchain.pdf"
  • Change management protocol related to the AS as per B.I.e.2#2 req.
    the automatically assigned file name "vbIe2-2-change-management-protocol-as-substprodchain.pdf"
  • Justification for the proposed deletion as per B.I.e.3#1 req.
    the automatically assigned file name "vbIe3-1-justif-proposed-deletion-substprodchain.pdf"
  • Declaration of changes as per B.I.e.4#1 req.
    the automatically assigned file name "vbIe4-1-declaration-changes-substprodchain.pdf"
  • Ref. to the approved change management protocol as per B.I.e.5#1 req.
    the automatically assigned file name "vbIe5-1-ref-appr.-change-management-protocol-substprodchain.pdf"
  • Declaration about the change as per B.I.e.5#2 req.
    the automatically assigned file name "vbIe5-2-declaration-change-substprodchain.pdf"
  • Studies results as per B.I.e.5#3 req.
    the automatically assigned file name "vbIe5-3-studies-results-substprodchain.pdf"
  • Management protocol change - as per B.I.e.4 type ll req.
    the automatically assigned file name "vbie4-management-protocol-change-1-type-ll-substprodchain.pdf"