In brief
Published on 4 April 2025
Donated breast milk is prepared in lactariums to meet the specific therapeutic needs of vulnerable newborns, particularly very premature babies. Its use for therapeutic purposes is rigorously monitored, notably through biovigilance. The Agence de la biomédecine oversees this activity in France, to guarantee the safety of breast milk for therapeutic use throughout its life cycle.
A supervised activity
Breast milk for therapeutic use requires strict monitoring, from collection from donor mothers to administration to newborns. A biovigilance system is in place to identify, report and analyze any incidents or adverse effects occurring during the process from donation to use of breast milk for therapeutic purposes. Health establishments and lactariums play an active role in this system, providing the Agence de la biomédecine with all relevant information concerning the safety of this product derived from the human body.
The Agency's role
The Agence de la biomédecine is responsible for the national biovigilance system for breast milk for therapeutic use. It collects and analyzes reports of undesirable events submitted by the establishments and professionals concerned, in order to identify potential risks, understand their causes and draw up recommendations aimed at reinforcing the safety of practices. The Agency provides healthcare professionals with tools to facilitate the reporting and follow-up of incidents, and regularly publishes reports to continuously improve health safety in this field.
In this section, you will find information and documents relating to the biovigilance system set up by the Agence de la biomédecine concerning the use of breast milk for therapeutic purposes.
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