Article R5312-1 of the French Public Health Code
For the implementation of the monitoring and alert system mentioned in article L. 5312-4, the Agence nationale de sécurité du médicament et des produits de santé is responsible for receiving and processing reports of medicinal products suspected of being falsified and quality defects suspected of affecting medicinal products. This system also covers recalls of medicinal products by the companies or organisations that operate them, and withdrawals of medicinal products from…