French Business Law - French Legislation

Article L5442-15 of the French Public Health Code

November 6, 2023

I.-The administrative authority may, as long as the public prosecution has not been initiated and after having obtained the agreement of the public prosecutor, compromise on the prosecution of contraventions and offences provided for and punished by this chapter and the texts taken for their application. II.- This option does not apply to offences punishable by a prison sentence of three years or more and to offences of the first…

Article L5451-1 of the French Public Health Code

November 6, 2023

The following is punishable by two years’ imprisonment and a fine of €150,000: 1° Continuing, with regard to the products concerned, activities which have been the subject of one of the suspension or prohibition measures provided for in articles L. 5312-1, L. 5312-1-1 and L. 5312-2 ; 2° Not complying with the special conditions or restrictions which may be imposed in the interests of public health on the prescription, supply,…

Article L5451-2 of the French Public Health Code

November 6, 2023

Natural persons guilty of the offences referred to in Article L. 5451-1 shall also be 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…

Article L5451-3 of the French Public Health Code

November 6, 2023

Legal entities held criminally liable, under the conditions laid down in Article 121-2 of the French Penal Code, for the offences defined in Article L. 5451-1 shall be liable, in addition to a fine in accordance with the procedures laid down in Article 131-38 of the French Penal Code: 1° (Repealed) ; 2° Confiscation of the thing that was used or intended to be used to commit the offence or…

Article L5451-4 of the French Public Health Code

November 6, 2023

The provisions of the first three paragraphs of article L. 4163-2 are applicable to the persons mentioned in the fifth and sixth paragraphs of article L. 5323-4. The provisions of the following paragraphs of the same article apply to natural and legal persons who offer or provide benefits to these persons.

Article L5461-1 of the French Public Health Code

November 6, 2023

The following are empowered to investigate and record infringements and breaches of the provisions of Title I of Book II of this Part, as set out in Articles L. 5461-2 to L. 5461-9, as well as the regulatory measures taken for the application of these provisions: 1° Pharmacist public health inspectors and inspectors from regional health agencies who are pharmacists, under the conditions set out in Articles L. 5411-1 to…

Article L5461-2 of the French Public Health Code

November 6, 2023

I.-If the manufacturer of a device referred to in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 or, where applicable, its authorised representative, having become aware of a serious incident occurring on French territory concerning this device, fails to notify the National Agency for the Safety of Medicines and Health Products in accordance with the procedures and time limits laid…

Article L5461-2-1 of the French Public Health Code

November 6, 2023

Failure by the importer or distributor of a device to immediately inform the Agence nationale de sécurité du médicament et des produits de santé, pursuant to Article 13(7) of Regulation (EU) 2017/745 or Article 14(4) of the same Regulation, that the device it has placed on the market, put into service or made available on French territory presents a serious risk or is a falsified device, is punishable by one…

Article L5461-3 of the French Public Health Code

November 6, 2023

I.-Placing on the market or putting into service on French territory a medical device or its accessories is punishable by five years’ imprisonment and a fine of 375,000 euros: 1° Without the EU declaration of conformity having been drawn up in accordance with Article 19 of Regulation (EU) 2017/745; 2° For which the CE marking provided for in Article 20 of Regulation (EU) 2017/745 has been improperly affixed; 3° In…

Article L5461-4 of the French Public Health Code

November 6, 2023

Failure by the manufacturer, authorised representative or importer of devices referred to in Article 1 of Regulation (EU) 2017/745, whose registered office is located on French territory, to register it or update the information concerning it, in accordance with the procedures laid down in Article 31 of the same Regulation, shall be punishable by one year’s imprisonment and a fine of €75,000.

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Legislative part

Article L5442-15 of the French Public Health Code

Article L5451-1 of the French Public Health Code

Article L5451-2 of the French Public Health Code

Article L5451-3 of the French Public Health Code

Article L5451-4 of the French Public Health Code

Article L5461-1 of the French Public Health Code

Article L5461-2 of the French Public Health Code

Article L5461-2-1 of the French Public Health Code

Article L5461-3 of the French Public Health Code

Article L5461-4 of the French Public Health Code

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Legislative part

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