The following classes of documents related to the Medicinal Product Safety, Efficacy and Pharmacovigilance Changes are appropriate as a basis for change for a Medicinal Product entity:

• Safety, Efficacy, Pharmacovigilance - Commission Decision or CMDh agreement as per C.I.1#1  req.
  the automatically assigned file name "vci1-1-commission-decision-cmdh-agreement-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Declaration as per C.I.1#2  req.
  the automatically assigned file name "vci1-2-declaration-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Assessment of the reference MP as per C.I.2#1  req.
  the automatically assigned file name "vci2-1-commission-decision-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Assessment of the comp. authority as per C.I.3#1  req.
  the automatically assigned file name "vci3-1-assesment-comp-auth-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Decision legal status change of the ref. MP as per C.I.5#1  req.
  the automatically assigned file name "vci5-1-decision-legal-status-change-ref-mp-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Declaration as per C.I.7#1  req.
  the automatically assigned file name "vci7-1-declaration-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Changes to a  Pharmacovigilance System as per C.I.8#1  req.
  the automatically assigned file name "vci8-1-changes-pharmacovigilance-system-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Detailed description Pharmacovigilance System as per C.I.9#1  req.
  the automatically assigned file name "vci9-1-detailed-descript-pharmacovig-system-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Competent Authority approval to PSUR frequency submission change as per C.I.10#1  req.
  the automatically assigned file name "vci10-1-ca-approval-psur-frequency-subm-change-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - Approved wording of changes to the risk management plan as per C.I.11#1  req.
  the automatically assigned file name "vci11-1-detailed-descript-pharmacovig-system-medprod.pdf"
• Safety, Efficacy, Pharmacovigilance - List of MP subjected to additional monitoring as per C.I.12#1  req.
  the automatically assigned file name "vci12-1-list-mp-additional-monitoring-medprod.pdf"