We take responsibility for compliance with local requirements for reporting quality defects to the ANSM.
Quality defects deemed by the manufacturer and Cevidra to have a potential impact on patient safety must be reported to the ANSM following a process and filing documentation imposed by the authorities.
Depending on the seriousness of the defect and the impact on the patient, public authorities, the manufacturer and/or Cevidra may decide to recall the incriminated batch or batches. The process for the decision to recall a batch by the manufacturer, the MA holder and Cevidra is formalized in the QTA drawn up beforehand.
Cevidra’s structure is organized to initiate, implement and monitor the recall of a batch alongside public authorities. The operating laboratory is required to send a message subject to prior validation from public authorities to all recipients of the incriminated batch and to monitor the quantities returned through the “DP Recall Batch” portal made available to Exploitants in France.