Article L5431-8 of the French Public Health Code
The failure of the responsible person, as defined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, and distributors, as defined in Article 2(1)(e) of the same Regulation, failing to report to the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), without delay and by…