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

• Appropriate data on the new packaging as per B.ll.e.1#2 req.
  the automatically assigned file name "vblle1-2-appropriate-data-on-the-new-packaging-medprodchain.pdf"
• Proof of non-interaction content - packaging as per B.ll.e.1#3 req.
  the automatically assigned file name "vblle1-3-proof-non-interaction-content-packg-medprodchain.pdf"
• Declaration - ICH-VICH stability study started as per B.ll.e.1#4 req.
  the automatically assigned file name "vblle1-4-declaration-ich-vich-stability-study-started-medprodchain.pdf"
• ICH - VICH stability study results as per B.ll.e.1#5 req.
  the automatically assigned file name "vblle1-5-ich-vich-stability-study-results-medprodchain.pdf"
• Comparison of current and proposed spec imd. pack. as per B.ll.e.1#6 req.
  the automatically assigned file name "vblle1-6-compar-current-proposed-spec-imd-pack-medprodchain.pdf"
• Samples of the new container - closure as per B.ll.e.1#7 req.
  the automatically assigned file name "vblle1-7-samples-new-container-closure-medprodchain.pdf"
• Declaration remaining pack-sizes adequate as per B.ll.e.1#8 req.
  the automatically assigned file name "vblle1-8-tbl-current-proposed-spec-medprodchain.pdf"
• Change in immediate pack. of the finish. prod. - as per B.ll.e.1 type ll req.
  the automatically assigned file name "vbiie1-change-immed-pack-type-ll-medprodchain.pdf"
  
• Comparative table of current and proposed spec. as per B.ll.e.2#2 req.
  the automatically assigned file name "vblle2-2-comp-table-current-proposed-spec-var.pdf"
• Details of new analytical method and validation data as per B.ll.e.2#3 req.
  the automatically assigned file name "vblle2-3-new-analitical-method-and-validation-data-var.pdf"
• Batch analysis of two batches of immediate packaging as per B.ll.e.2#4 req.
  the automatically assigned file name "vblle2-4-batch-analysis-two-batches-immed-packg-var.pdf"
• Justification/risk asses. parameter non-significant as per B.ll.e.2#5 req.
  the automatically assigned file name "vblle2-5-justification-risk-asses-parameter-non-signif-var.pdf"
• Justification of the new spec. parameter as per B.ll.e.2#6 req.
  the automatically assigned file name "vblle2-6-justification-new-spec-parameter-var.pdf"
• Validation results test procedure for immediate packaging as per B.II.e.3-2
  the automatically assigned file name "vblle3-2-test-validation-results-immediate-packaging-var.pdf"
• Revalidation studies for sterile products as per B.II.e.4-3
  the automatically assigned file name "vblle4-3-revalidation-studies-sterile-product-var.pdf"
• Declaration stability studies started per B.II.e.4-4
  the automatically assigned file name "vblle4-4-declaration-stability-studies-started-var.pdf"
• Change in shape or dimensions of the immediate packaging - as per B.ll.e.4 type ll req.
  the automatically assigned file name "vbiie4-change-immed-pack-shape-type-ll-medprodchain.pdf"
•  Justification of the new/remaining pack size as per B.ll.e.5#2 req.
  the automatically assigned file name "vblle5-2-justification-new-remaining -pack-size-var.pdf"
• Declaration - stability studies will be conducted as per B.ll.e.5#3 req.
  the automatically assigned file name "vblle5-3-declaration-stability-studies-will-be-conducted-var.pdf"
• Change in pack size of the finished product - as per B.ll.e.5 type ll req.
  the automatically assigned file name "vbiie5-change-pack-size-type-ll-medprodchain.pdf"
• Proof of  CE marking as per B.II.e.7-2
  the automatically assigned file name "vblle7-2-proof-ce-marking-var.pdf"
• Comparative table of current and proposed specification as per B.II.e.7-3
  the automatically assigned file name "vblle7-3-table-current-prposed-specification-var.pdf"
• Change in supplier of packaging components - as per B.ll.e.7 type ll req.
  the automatically assigned file name "vbiie7-change-supplier-pack-components-type-ll-medprodchain.pdf"