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"