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

• Results of the appropriate Ph. Eur tests as per B.ll.a.1#3 req.
  vblla1-3-results-ph-eur-tests-medprod.pdf"
• Comparative dissol. data on pilot batch(s) as per B.ll.a.2#2 req.
  the automatically assigned file name "vblla2-2-dissol-data-on-pilot-batch-medprod.pdf"
  
• Justification for not submitting bioequivalence study as per B.ll.a.2#3 req.
  the automatically assigned file name "vblla2-3-justif-not-submitted-bioequivalence-study-medprod.pdf"
  
• Results of the appropriate Ph. Eur tests as per B.ll.a.2#5 req.
  the automatically assigned file name "vblla2-5-results-ph-eur-tests-medprod.pdf"
  
• Declaration required stability studies started as per B.ll.a.3.#2 req.
  the automatically assigned file name "vblla3-2-declaration-stability-stud-started-medprod.pdf"
  
• Declaration results from stability studies as per B.ll.a.3.#3 req.
  the automatically assigned file name "vblla3-3-results-stability-stud-medprod.pdf"
  
• Ph. Eur. Cert. of Suitability for TSE risk of new component as per B.ll.a.3.#5 req.
  the automatically assigned file name "vblla3-5-ph-eur-cert-tse-risk-medprod.pdf"
  
• Data excipient does not interfere with test methods as per B.ll.a.3.#6 req.
  the automatically assigned file name "vblla3-6-excipient-does-not-interfere-with-test-methods-medprod.pdf"
  
• Justification for the change-choice of excipients as per B.ll.a.3.#7 req.
  the automatically assigned file name "vblla3-7-justification-change-choice-excipients-medprod.pdf"
  
• Comparative dissol. profile on pilot batches as per B.ll.a.3.#8 req.
  the automatically assigned file name "vblla3-8-dissol-profile-on-pilot-batch-medprod.pdf"
  
• Justification for not submitting bioequivalence study as per B.ll.a.3.#9 req.
  the automatically assigned file name "vblla3-9-justif-not-submitting-bioequivalence-study-medprod.pdf"
  
• Declaration required stability studies started as per B.ll.a.4.#2 req.
  the automatically assigned file name "vblla4-2-declaration-stability-stud-started-medprod.pdf"
  
• Justification for deletion of solvent-diluent container as per B.ll.a.6#1 req.
  the automatically assigned file name "vblla6-1-justif-deletion-solvent-diluent-container-medprod.pdf"
  
• Kit addition change - as per B.ll.a.2 type ll req.
  the automatically assigned file name "vblla2-kit-addition-change-1-type-ll-var.pdf"
  
• Excipient change - as per B.ll.a.3 type ll req.
  the automatically assigned file name "vblla3-excipient-change-1-type-ll-var.pdf"
  
• Coating change - as per B.ll.a.4 type ll req.
  the automatically assigned file name "vblla4-coating-change-1-type-ll-var.pdf"
  
• Concentration change - as per B.ll.a.5 type ll req.
  the automatically assigned file name "vblla5-concentration-change-1-type-ll-var.pdf"