. The types of changes that should be routinely and promptly notified to the QPPV are:
• Updates to the pharmacovigilance system master file or its location that are notified to the
competent authorities;
• The addition of corrective and/or preventative actions to the pharmacovigilance system master file
(e.g. following audits and inspections). The QPPV should also be able to access information about
deviations from the processes defined in the quality management system for pharmacovigilance;
• Changes to content that fulfill the criteria for appropriate oversight of the pharmacovigilance system (in terms of capacity, functioning and compliance);
• Changes in arrangements for the provision of the pharmacovigilance system master file to
competent authorities;
• Transfer of significant services for pharmacovigilance to a third party (e.g. outsourcing of PSUR
production);
• Inclusion of products into the pharmacovigilance system for which the QPPV is responsible;
• Changes for existing products which may require a change or increased workload in relation to
pharmacovigilance activity e.g. new indications, studies or the addition of territories.

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