Chapter VI: Gene therapy preparations and xenogenic cell therapy preparations.

I.-The act or attempt to distribute or transfer, free of charge or for a consideration, gene therapy preparations or xenogenic cell therapy preparations without authorisation or when authorisation is suspended or withdrawn is punishable by five years’ imprisonment and 375,000 €. II – The same penalties apply to the act or attempted act of: 1° Importing or exporting gene therapy preparations or xenogenic cell therapy preparations without the authorisation referred…

The following constitutes a breach subject to a financial penalty: 1° Distributing or transferring gene therapy preparations or xenogenic cell therapy preparations, whether free of charge or for consideration, without authorisation or when the authorisation is suspended or withdrawn; 2° Preparing, storing, distributing, transferring, importing or exporting gene therapy preparations or xenogenic cell therapy preparations without complying with the rules of good practice defined in the decisions or orders issued…

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