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23/02/2022

Declare a quality defect

A quality defect may be observed on one or more batches of medicinal products placed on the market and may lead to a batch recall. This is declared to Anses — ANMV by the laboratory responsible for placing it on the market (operator).

Operator’s declaration of quality defect form

Any declaration of quality defects should be sent to the inspection, surveillance and pharmacovigilance department on the mailbox: DQ_ANMV@anses.fr