Subsection 2: Organisation

The in-house pharmacies referred to in Article L. 5126-1 shall forward to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, immediately upon request, a report summarising the information relating to the adverse reactions which they have reported or which have been reported to them and all the information useful for assessing the risks and benefits associated with the use of the hospital…

The procedures and standard form for the declarations and report mentioned in Articles R. 5121-174 to R. 5121-176 are laid down by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.