Insights

In case of a quality defect or safety issue of a medicinal product is identified and the product recall procedure is necessary, the Marketing Authorisation Holder (MAH) has to inform immediately AIFA and simultaneously starts an efficient and swift recall procedure to mitigate any potential risks associated with the defective product.

To effectively navigate this situation, the MAH along with all entities participating in the distribution of the medicinal product must establish comprehensive procedures, with a precise delineation of responsibilities, for managing the recall of medicinal product batches from the Italian market.

The MAH is expected to notify distributors, logistics partners, trade associations, and healthcare institutions to prevent further use of the medicinal product, verify both unsold and sold stock levels while identifying recipients, check for the product’s presence within the distribution network, and ensure full traceability of all product batches.

AIFA outlines the timeframe allotted to the Marketing Authorization Holder (MAH) for demonstrating the initiation of recall procedures and informs accordingly several trade associations, Italian databases, Istituto Superiore di Sanità (ISS), NAS (department of the National Military Police responsible for control of medicines), Regions, etc.

RPN will provide any further update and is available to support for these activities.