The following classes of documents related to the Marketed Substance Specification are appropriate as a basis for change for a Marketed Substance entity:

• Table of current and proposed specification as per B.I.b.1#2 req.
  the automatically assigned file name "vbib1-2-table-current-proposed-specification-mrktsubst.pdf"
• Analytical method details as per B.I.b.1#3 req.
  the automatically assigned file name "vbib1-3-analytical-method-details-mrktsubst.pdf"
• Batch analysis data as per B.I.b.1#4 req.
  the automatically assigned file name "vbib1-4-batch-analysis-data-mrktsubst.pdf"
• Comparative dissolution profile data as per B.I.b.1#5 req.
  the automatically assigned file name "vbib1-5-comparative-dissolution-profile-data-mrktsubst.pdf"
• Justification for deletion of spec. parameter as per B.I.b.1#6  req.
  automatically assigned file name "vbib1-6-justification-for-deletion-spec-parameter-mrktsubst.pdf"
• Justification for the new spec. parameter and limits as per B.I.b.1#7 req.
  the automatically assigned file name "vbib1-7-justification-for-new-spec-parameter-limits-mrktsubst.pdf"
• Specification - change - as per B.I.b.1 type ll req.
  vbib1-specification-change-type-ll-var.pdf
• Comparative table of current and proposed spec. as per B.Ill.2#2 req.
  the automatically assigned file name "vbiii2-2-comparative-table-current-proposed-spec.pdf"
• Batch analysis data on two production batches as per B.Ill.2#3 req.
  the automatically assigned file name "vbiii2-3-batch-analysis-data-two-production-batches.pdf"
• Data to demonstrate suitability of monograph as per B.Ill.2#4 req.
  the automatically assigned file name "vbiii2-2-treba 4data-to-demonstrate-suitability-of-monograph.pdf"