Book IV: Criminal and financial penalties

I. – It is an offence to market, broker or distribute, whether free of charge or for a consideration, wholesale or retail, a proprietary medicinal product, any other medicinal product manufactured industrially or according to a method involving an industrial process, as well as any generator, kit or precursor as defined respectively in 8°, 9° and 10° of article L. 5121-1, without a marketing authorisation, a temporary use authorisation, an…

I. – It is an offence to market, broker or distribute, whether free of charge or against payment, wholesale or retail, homeopathic medicinal products mentioned in 11° of article L. 5121-1 or traditional herbal medicinal products mentioned in article L. 5121-14-1 which have not been registered with the Agence nationale de sécurité du médicament et des produits de santé, or whose registration with this agency has been refused, suspended, withdrawn…

Failure by any person exploiting a medicinal product or product to communicate any new information likely to influence the assessment of the benefits and risks of the medicinal product or product concerned pursuant to article L. 5121-9-2 or to transmit the data requested by the Agency within the time limits set by it pursuant to article L. 5121-9-3 is punishable by two years’ imprisonment and a fine of €150,000.

Failure by any person exploiting a medicinal product or product to notify the Agence nationale de sécurité du médicament et des produits de santé of any prohibition or restriction imposed by the competent authorities of any country in which the medicinal product or product is marketed pursuant to article L. 5121-9-2 is punishable by two years’ imprisonment and a fine of €150,000.

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.