French Public Health Code
In forceThe following constitutes a breach subject to a financial penalty:
1° Failure by a marketing authorisation holder or a pharmaceutical company exploiting a medicinal product to constitute the safety stock intended for the national market in application of the second paragraph of article L. 5121-29;
2° Any marketing authorisation holder or pharmaceutical company exploiting a medicinal product of major therapeutic interest mentioned in article L. 5111-4 for which there are no alternatives available on the French market and which takes the decision to suspend or cease its marketing, or which is aware of facts likely to lead to the suspension or cessation of this marketing, not to inform the Agence nationale de sécurité du médicament et des produits de santé, in disregard of the provisions of the first paragraph of Article L. 5124-6, at least one year before the planned or foreseeable date of suspension or cessation, or not to indicate the reason for this action ;
3° For a marketing authorisation holder or a pharmaceutical company exploiting a medicinal product of major therapeutic interest mentioned in article L. 5111-4 to cease marketing it before the end of the period required to introduce alternative solutions to cover this need, in disregard of the provisions of the first paragraph of article L. 5124-6 ;
4° Failure by a marketing authorisation holder or a pharmaceutical company exploiting a medicinal product to inform the Agence nationale de sécurité du médicament et des produits de santé immediately of any action it has taken to suspend marketing in an emergency or to withdraw a given batch, in breach of the provisions of the second paragraph of Article L. 5124-6;
5° For a marketing authorisation holder or a pharmaceutical company exploiting either a medicinal product of major therapeutic interest mentioned in article L. 5111-4, or a vaccine mentioned in b of 6° of article L. 5121-1, the list of which is set by order of the Minister for Health pursuant to the second paragraph of article L. 5121-31:
a) Failing to comply with the obligation to draw up and implement a shortage management plan to prevent and remedy any stock shortages, as provided for in Article L. 5121-31 ;
b) Or failing to declare to the Agence nationale de sécurité du médicament et des produits de santé, in breach of the provisions of article L. 5121-31, the list of medicinal products for which it is drawing up a shortage management plan;
c) Or failing to include sufficient measures in the shortage management plan to deal with a stock-out situation;
6° For a marketing authorisation holder or a pharmaceutical company exploiting either a medicinal product of major therapeutic interest mentioned in article L. 5111-4 for which, due to its characteristics, the stock shortage or the risk of a stock shortage presents a serious and immediate risk for patients, or a vaccine mentioned in b of 6° of article L. 5121-1, the list of which is drawn up by order of the Minister for Health in application of the second paragraph of Article L. 5121-31, not to import an alternative to the medicinal product that is out of stock, as required by the National Agency for the Safety of Medicines and Health Products in application of I of Article L. 5121-33 ;
7° For a marketing authorisation holder or a pharmaceutical company exploiting a medicinal product of major therapeutic interest mentioned in article L. 5111-4:
a) Failing to inform the Agence nationale de sécurité du médicament et des produits de santé of any risk of a stock shortage or any stock shortage of this medicinal product as soon as they become aware of it, in disregard of the first paragraph of Article L. 5121-32 ;
b) Or, if it has provided this information, not to implement, where applicable, the measures provided for in the shortage management plan required in application of article L. 5121-31 ;
c) Or not to implement the support and information measures for healthcare professionals and patients provided for in the last paragraph of Article L. 5121-32.
