Chapter Ic: Combating drug supply shortages

Marketing authorisation holders and pharmaceutical companies exploiting medicinal products ensure an appropriate and continuous supply of the national market in order to cover the needs of patients in France. To this end, any marketing authorisation holder and any pharmaceutical company exploiting a medicinal product shall build up a safety stock intended for the national market and located on French territory, on that of another Member State of the European Union…

The list of medicinal products of major therapeutic interest mentioned in article L. 5121-31 for which a stock shortage or a risk of a stock shortage is identified or has been declared to the Agence nationale de sécurité du médicament et des produits de santé under the conditions mentioned in article L. 5121-32 is drawn up by decision of the Director General of the Agency and published on its website….

For the medicinal products of major therapeutic interest mentioned in article L. 5111-4 , marketing authorisation holders and pharmaceutical companies exploiting medicinal products draw up and implement shortage management plans, the purpose of which is, in the interest of patients, to prevent and remedy any stock shortages. Marketing authorisation holders and pharmaceutical companies exploiting medicinal products draw up and implement the shortage management plans provided for in the first paragraph…

Marketing authorisation holders and pharmaceutical companies exploiting a medicinal product of major therapeutic interest mentioned in article L. 5111-4 inform the Agence nationale de sécurité du médicament et des produits de santé of any risk of stock shortage or any stock shortage relating to this medicinal product as soon as they are aware of it, under conditions defined by regulation. With the agreement of the Agency, they shall put in…

The provisions of articles L. 5121-29 to L. 5121-32 and of the I of article L. 5121-33 do not apply to the Pharmacie centrale des armées, when the latter holds a marketing authorisation or exploits a medicinal product.

I. – Except in cases of force majeure, in the event of a stock shortage of a medicinal product of major therapeutic interest for which a stock shortage or risk of a stock shortage presents a serious and immediate risk for patients, or of a vaccine mentioned in the second paragraph of article L. 5121-31, and where neither the medicinal product alternatives that may be available on national territory nor…

The conditions for the application of this chapter shall be determined by decree of the Conseil d’Etat.