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Title VII: Implementation of financial penalties

Article L5471-1 of the French Public Health Code

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…

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Article L5472-1 of the French Public Health Code

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. –…

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Article L5472-2 of the French Public Health Code

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…

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Article L5473-1 of the French Public Health Code

I.-Within the area of competence determined in II of articles L. 5211-2 and L. 5221-2, the administrative authority responsible for competition and consumer affairs mentioned in article L. 522-1 of the Consumer Code may impose a financial penalty on the perpetrator of an infringement mentioned in articles L. 5461-9 and L. 5462-8 of this Code, in accordance with the procedure laid down in Chapter II of Title II of Book…

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Article L5473-3 of the French Public Health Code

The same person may not be the subject, for the same acts, of sanction proceedings initiated by the Agence nationale de sécurité du médicament et des produits de santé on the basis of article L. 5471-1 and by the administrative authority responsible for competition and consumer affairs on the basis of article L. 5473-1. To this end, the two authorities shall exchange the necessary information before any procedure is initiated.

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