Part five: Health products

Failure 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) of the cessation of marketing of a medicinal product in another State and failure to inform it of the reason for this cessation of marketing pursuant to article L. 5121-9-4 is punishable by two years’ imprisonment and a fine…

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 fails to comply with the obligations to report a serious adverse reaction suspected to be due to this medicinal product or product of which he has been made aware is liable to two years’ imprisonment and a fine of €150,000.

Any person involved in the manufacture, use, import, export or wholesale distribution of blood-derived medicinal products who fails to record the data required to monitor them pursuant to 14° of article L. 5121-20 is liable to two years’ imprisonment and a fine of 150,000 euros.

When a prosecution is brought by the judicial authority in application of the articles in this chapter, the representative of the State in the département may order the temporary closure of the establishment. Natural persons guilty of an offence under this chapter are liable to the additional penalty of temporary or permanent closure of the establishment.

The 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…

Attempted offences under articles L. 5421-2 and L. 5421-3 are punishable by the same penalties.

For the criminal offences referred to in this Title, natural persons are also liable to the following additional penalties: 1° Display or dissemination of the decision handed down, under the conditions and subject to the penalties provided for in article 131-35 of the Criminal Code ; 2° Temporary or permanent disqualification from exercising one or more professions governed by this Code, a commercial or industrial profession, from directing, administering, managing…

Legal entities declared criminally liable, under the conditions set out inarticle 121-2 of the French Criminal Code, for the offences set out in this Title shall incur, in addition to the fine set out in article 131-38 of the same Code, the penalties set out in 2° to 9° of article 131-39 of the said Code.