Chapter VIII: Raw materials for pharmaceutical use

The following constitutes a breach subject to a financial penalty: 1° Failure by manufacturers, importers or distributors of active substances to comply with the good manufacturing and distribution practices referred to in the first and second paragraphs of article L. 5138-3 ; 2° Failure by any pharmaceutical establishment mentioned in article L. 5124-1, dispensing pharmacies, pharmacies for internal use or doctors to ensure that the active substances they use comply…

Any manufacturer, importer or distributor of excipients as defined by Article L. 5138-2 who carries on business without having made a declaration to the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) in accordance with the conditions set out in Article L. 5138-1 is liable to one year’s imprisonment and a fine of €75,000.

Any manufacturer, importer or distributor of active substances as defined by Article L. 5138-2 who carries out his activity without having been authorised to do so by the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) pursuant to and under the conditions set out in Article L. 5138-1 is liable to two years’ imprisonment and a…

The manufacture, brokerage, distribution, advertising, offer for sale, sale, import, export or purchase of falsified raw materials for pharmaceutical use as defined in article L. 5138-6 are punishable by five years’ imprisonment and a fine of €375,000. These penalties are increased to seven years’ imprisonment and a fine of €750,000 when : 1° These raw materials are dangerous to human or animal health ; 2° The offences referred to in…

Anyone found to be in possession of falsified raw materials for pharmaceutical use without a legitimate reason is liable to three years’ imprisonment and a fine of €75,000. Where the falsified raw material for pharmaceutical use is dangerous to human or animal health, the penalties are increased to five years’ imprisonment and a fine of €375,000.

Any attempt to commit the offences referred to in article L. 5438-4 shall be subject to the same penalties.

For the criminal offences mentioned in this chapter, 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, from exercising a commercial or industrial profession, from directing, administering,…

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