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Article L5426-2 of the French Public Health Code

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whether free of charge or for consideration, without authorisation or when the authorisation is suspended or withdrawn; 2° Preparing, storing, distributing, transferring, importing or exporting gene therapy preparations or xenogenic cell therapy preparations without complying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…

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Article L5426-3 of the French Public Health Code

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,…

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Article L5426-4 of the French Public Health Code

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.

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Article L5431-1 of the French Public Health Code

The following are authorised to investigate and record breaches of the provisions of Chapter I of Title III of Book I of Part Five, and of the regulatory measures adopted for the application of these provisions: – public health inspecting pharmacists and inspectors from regional health agencies who are qualified pharmacists, under the conditions set out in articles L. 5411-1 to L. 5411-4 ; – inspectors from the Agence nationale…

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Article L5431-2 of the French Public Health Code

The following is punishable by two years’ imprisonment and a fine of €30,000: 1° For any person who manufactures or packages cosmetic products, to open or operate an establishment for the manufacture or packaging of these products, or to extend the activity of an establishment to include such operations, without first making the declaration provided for in Article L. 5131-2 to the Agence nationale de sécurité du médicament et des…

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Article L5431-3 of the French Public Health Code

Natural persons guilty of the offences defined in article L. 5431-2 are also liable to the following additional penalties: 1° Dissemination of the sentence and one or more messages informing the public of the sentence, under the conditions set out in article 131-35 of the French Penal Code ; 2° Posting the sentence, under the conditions and subject to the penalties provided for in article 131-35 of the same code;…

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Article L5431-4 of the French Public Health Code

Legal entities declared criminally liable, under the conditions set out in Article 121-2 of the French Penal Code, for the offences defined in Article L. 5431-2 shall be liable, in addition to a fine in accordance with the terms and conditions set out in Article 131-38 of the French Penal Code: 1° (Repealed) ; 2° Confiscation of the thing that was used or intended to be used to commit the…

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Article L5431-5 of the French Public Health Code

The person responsible, as determined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, for placing on the market, free of charge or for consideration, a cosmetic product which does not comply with the rules on the substances it contains, as set out in Article 14 and Article 15(1) and (2) of the same Regulation, shall…

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Article L5431-6 of the French Public Health Code

The person responsible, as determined by Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products, shall be liable to one year’s imprisonment and a fine of 15,000 euros for: 1° Placing a cosmetic product on the market, whether free of charge or against payment, without making the information file provided for in paragraph 1 of Article 11…

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Article L5431-7 of the French Public Health Code

A fine of 15,000 euros shall be imposed on the person responsible, as defined in Article 4 of Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009, for placing on the market, free of charge or for consideration, a cosmetic product whose container or packaging does not bear one of the indications provided for in Article 19 of the same Regulation.

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