VIII.B.7. Quality systems, audits and inspections

The marketing authorisation holder shall ensure the fulfilment of its pharmacovigilance obligations in relation to the study and that this can be audited, inspected and verified. For PASS imposed as an obligation, the marketing authorisation holder shall ensure that the analytical dataset and statistical programmes used for generating the data included in the final study report are kept in electronic format and are available for auditing and inspection [IR 12, IR Art 36].

For PASS required in the risk management plan agreed in the EU or conducted voluntarily in the EU, record management and data retention shall follow the provisions of IR Art 12.