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.
I.-The following is punishable by two years’ imprisonment and a fine of €150,000: 1° Continuing, with regard to the devices mentioned in Article 1 of Regulation (EU) 2017/746 the activities that have been the subject of one of the measures provided for in paragraph 4 of Article 90, paragraph 2 of Article 92 and paragraph 1 of Article 93 of this Regulation; 2° Failing to carry out the withdrawal or…
The following constitutes a breach subject to a financial penalty: 1° The fact, for the manufacturer of a device mentioned in Article 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 or, where applicable, for its authorised representative, having become aware of a serious incident occurring on French territory concerning this device, of failing to notify it to the National Agency for…
In addition to the officers and agents of the judicial police acting in accordance with the provisions of the Code of Criminal Procedure, the agents mentioned in article L. 511-3 and in 1° and 2° of I of article L. 511-22 of the Consumer Code and the doctors appointed by the Director General of the Regional Health Agency are authorised to investigate and record breaches of the provisions of article…
Ignoring the prohibitions mentioned in article L. 5231-1 is punishable by two years’ imprisonment and a fine of €3,750.
I.-The Agence nationale de sécurité du médicament et des produits de santé may impose a financial penalty on the perpetrator of a breach of the provisions of articles L. 5421-8 , L. 5422-18 , L. 5423-8 , L. 5423-9, L. 5426-2 , L. 5438-1 , L. 5461-9 and L. 5462-8 , except when the breach is committed in the course of retail distribution of healthcare products. II – The Agency…
Where a financial penalty imposed under this chapter may be combined with a criminal fine imposed on the offender for the same acts, the total amount of the fines and financial penalties imposed shall not exceed the highest legal maximum.
I. – The Director General of the regional health agency with territorial jurisdiction may, in the areas under his authority, impose a financial penalty on the perpetrator of a breach of the provisions of Articles L. 5424-2 to L. 5424-4 and, where the breach is committed in connection with the retail distribution of health products, of Article L. 5421-8, Article L. 5426-2 and Article L. 5438-1, paragraph 2. II. –…
I. – In the event of a breach of the provisions of 9° of Article L. 5424-4, the Director General of the regional health agency with territorial jurisdiction may, after giving formal notice, except in emergencies, within a period set by him and which may not be less than eight days, to the person responsible for the breach to comply with his instructions and to submit his observations: 1° Order…
Where a financial penalty imposed under this chapter may be combined with a criminal fine imposed on the offender for the same acts, the total amount of the fines and financial penalties imposed shall not exceed the highest legal maximum.
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is a Registered Trademark of
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182, rue de Rivoli
75001, Paris France
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is a Registered Trademark of
PETROFF LAW FIRM (SELARL LEGASTRAT)
182, rue de Rivoli
75001, Paris France
RCS Paris n°814433470
Paris Bar Registration n° (Toque) C2396
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