French Public Health Code
In forceI.-Any marketing authorisation holder and any pharmaceutical company exploiting a medicinal product in France shall build up a safety stock intended for the national market referred to in article L. 5121-29, in accordance with the procedures defined in this article.
Safety stock means the stocking of a number of units of finished product of a medicinal product ready for distribution on French territory, at least equivalent to the period of coverage of needs fixed below, calculated on the basis of the volume of sales in France of the medicinal product over the last twelve sliding months excluding exceptional situations.
II.-Unless otherwise stipulated, the minimum safety stock corresponds to:
1° For any medicinal product of major therapeutic interest mentioned in article L. 5111-4, at least two months' coverage of requirements;
2° For any other medicinal product not covered by article L. 5111-4, one week's coverage of requirements. This safety stock is increased to one month for medicinal products contributing to a public health policy defined by the Minister responsible for health.
III. -For medicinal products of major therapeutic interest, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may decide, at the request of the marketing authorisation holder or the pharmaceutical company exploiting the medicinal product, in accordance with the procedures defined by decision of the Director General of the Agency, to reduce, for a medicinal product, the safety stock threshold set in 1° of II, for one of the following reasons :
a) The shelf life of the medicinal product is incompatible with the threshold set at 1° of II;
b) The medicinal product is produced in a manner adapted to each patient or manufactured from products of human origin;
c) The seasonal nature of the medicinal product's requirements;
d) The medicinal product is a gas for medical use;
If the Director General of the Agency remains silent for more than two months following the submission of an application for a change to the safety stock threshold by marketing authorisation holders and pharmaceutical companies exploiting medicinal products, this will be deemed to constitute a rejection decision.
IV.For medicinal products of major therapeutic interest, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may also decide ex officio for a medicinal product to increase the safety stock threshold set in 1° of II, when the medicinal product is subject to the risk of stock-outs or regular stock-outs in the previous two calendar years, thus requiring a stock of more than two months to be built up, without exceeding four months' cover of needs.
Except in emergencies, marketing authorisation holders and pharmaceutical companies exploiting the medicinal products concerned must be given the opportunity to submit their observations to the Director General of the Agency within a period of fifteen days prior to the implementation of an ex officio modification of the safety stock threshold mentioned in 1° of II of this article.
The modification of the safety stock threshold takes effect within a period of six months from the notification of the decision of the Director General of the Agence nationale de sécurité du médicament et des produits de santé and for a period of two years. It may be renewed under the conditions mentioned in this IV.
V.-Information relating to these stocks is kept at the disposal of the Agence nationale de sécurité du médicament et des produits de santé and may be sent to it at any time at its request.
