The following classes of documents related to the Control of Excipients of the Medicinal Product are appropriate as a basis for change for a Medicinal Product - Preparation Production Chain entity:

• Table of current and proposed specification as per B.ll.c.1#2 req.
  the automatically assigned file name "vbllc1-2-table-current-proposed-specification-medprodchain.pdf"
• Details of new analytical method and validation data as per B.ll.c.1#3 req.
  the automatically assigned file name "vbllc1-3-analytical-method-validation-data-medprodchain.pdf"
• Batch analysis data as per B.ll.c.1#4 req.
  the automatically assigned file name "vbllc1-4-batch-analysis-data-medprodchain.pdf"
• Comparative dissolution profile data as per B.ll.c.1#5 req.
  the automatically assigned file name "vbllc1-5-comparative-dissolution-profile-data-medprodchain.pdf"
• Justification for not submitting bioequivalence study as per B.ll.c.1#6 req.
  the automatically assigned file name "vbllc1-6-justif-not-submitted-bioequivalence-study-medprodchain.pdf"
• Justification parameter non-significant-obsolete  as per B.ll.c.1#7 req.
  the automatically assigned file name "vbllc1-7-justif-parameter-non-significant-obsolete-medprodchain.pdf"
• Justification of new spec. parameter and limits as per B.ll.c.1#8 req.
  the automatically assigned file name "vbllc1-8-justif-new-spec-parameter-limits-medprodchain.pdf"
• Validation results for current and proposed tests as per B.ll.c.2#2 req.
  the automatically assigned file name "vbllc2-2-validation-results-current-proposed-tests-medprodchain.pdf"
• Manufacturer declaration of origin as per B.ll.c.3#1 req.
  the automatically assigned file name "vbllc3-1-batch-analysis-data-medprodchain.pdf"
• Study of equivalence of material as per B.ll.c.3#2 req.
  the automatically assigned file name "vbllc3-2-study-of-equivalence-medprodchain.pdf"
• Batch analysis data as per B.ll.c.4#2 req.
  the automatically assigned file name "vbllc4-2-batch-analysis-data-medprodchain.pdf"
• Comparative dissolution profile data as per B.ll.c.4#3 req.
  the automatically assigned file name "vbllc4-3-comparative-dissolution-profile-data-medprodchain.pdf"
• Approved/new specifications of the excipient as per B.ll.c.4#4 req.
  the automatically assigned file name "vbllc4-4-approved-new-specification-excipient-medprodchain.pdf"
• Parameter/limits change - as per B.ll.c.1 type ll req.
  the automatically assigned file name "vbllc1-parameters-limits-change-1-type-ll-var.pdf"
• Test procedure change - as per B.ll.c.2 type ll req.
  the automatically assigned file name "vbllc2-test-procedure-change-1-type-ll-var.pdf"
• TSE risk change - as per B.ll.c.3 type ll req.
  the automatically assigned file name "vbllc3-tse-risk-change-1-type-ll-var.pdf"
• Specification change - as per B.ll.c.4 type ll req.
  the automatically assigned file name "vbllc4-specification-change-1-type-ll-var.pdf"
• Synthesis change - as per B.ll.c.4 type ll req.
  the automatically assigned file name "vbllc4-synthesis-change-1-type-ll-var.pdf"