French Public Health Code
In forceI.-For the medicinal products of major therapeutic interest referred to in article L. 5111-4, marketing authorisation holders and pharmaceutical companies exploiting medicinal products shall, under their responsibility, draw up and implement the shortage management plans referred to in article L. 5121-31 in accordance with the guidelines defined by decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé.
These shortage management plans take into account the risks relating to the manufacturing and distribution cycle of the medicinal product concerned.
These shortage management plans provide for the constitution of safety stocks intended for the national market as defined in Article R. 5124-49-4 and, where appropriate, the identification of medicinal products which may constitute an alternative to the medicinal product in default. In addition, they may provide for other sites for the manufacture of raw materials for pharmaceutical use and other sites for the manufacture of proprietary medicinal products.
II.- Marketing authorisation holders and pharmaceutical companies exploiting medicinal products update and modify these shortage management plans as necessary.
III-The list of medicinal products of major therapeutic interest is mentioned in the statement of the establishment provided for in article R. 5124-46. The shortage management plans concerned are sent each year to the Agence nationale de sécurité du médicament et des produits de santé in accordance with the procedures defined by decision of the Director General of the Agency and are sent to it at any time at its request.
