French Public Health Code
In forceThe following constitutes a breach subject to a financial penalty:
1° Failure by any person exploiting a medicinal product or a product mentioned in article L. 5121-1 or by any holder of the authorisation provided for in article L. 4211-6 to comply with the obligation to implement a pharmacovigilance system, to manage the pharmacovigilance system permanent file and to carry out periodic audits;
2° Any person exploiting a medicinal product or product mentioned in article L. 5121-1 or any holder of the authorisation provided for in article L. 4211-6 who is aware of a suspected adverse reaction and fails to report it to the competent authorities or bodies in accordance with the procedures defined by regulation;
3° Failure by any person exploiting a medicinal product or product mentioned in article L. 5121-1 or by any holder of the authorisation provided for in article L. 4211-6, with regard to pharmacovigilance, to comply with the obligation to transmit the periodic safety update report or to maintain the presence of a responsible person at all times;
4° Failure by the applicant for a marketing authorisation to submit the results of the studies referred to in the first paragraph of article L. 5121-8 within the required timeframe;
5° Failure by the marketing authorisation holder to transmit the results of the studies referred to in article L. 5121-8-1 within the required timeframe. When this failure is also liable to be subject to a financial penalty under 4° bis of article L. 162-17-4 of the Social Security Code, the penalties may be combined up to the limit of the highest amount of one of the penalties incurred;
6° Failure to comply with the rules of good practice defined in the decisions or orders issued in application of Article L. 5121-5, with the exception of good practice in electronic dispensing;
7° The failure by any company which exploits the medicinal product or any prescriber to collect or transmit to the Haute Autorité de santé or, where applicable, to the Agence nationale de sécurité du médicament et des produits de santé, within the time limits set, the data and information mentioned in IV of article L. 5121-12 and in V of article L. 5121-12-1 ;
8° Failure by a company to comply with the obligations set out in the second paragraph of Article L. 5121-14-3 when no agreement between the Economic Committee for Health Products and the company has been concluded pursuant to Article L. 162-17-4-1 of the Social Security Code;
9° Failure by the marketing authorisation holder to comply with the obligation to inform the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products), giving reasons, as provided for in article L. 5121-9-4;
10° Failure by any person involved in the manufacture, use, import, export or wholesale distribution of blood-derived medicinal products to record the data required to monitor them pursuant to 14° of article L. 5121-20;
11° Failure by a company to communicate a prohibition or restriction imposed by the competent authorities of any country in which the medicinal product or health product is marketed, as well as any new information likely to influence the evaluation of the benefits and risks of the medicinal product or product concerned pursuant to article L. 5121-9-2, or failure to transmit the data requested by the Agency pursuant to article L. 5121-9-3 within the required timeframe;
12° Failure to comply with the obligations relating to the labelling, package leaflet and name of medicinal products and products.
