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Article L5438-2 of the French Public Health Code

Any manufacturer, importer or distributor of excipients as defined by Article L. 5138-2 who carries on business without having made a declaration to the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) in accordance with the conditions set out in Article L. 5138-1 is liable to one year’s imprisonment and a fine of €75,000.

Original in French 🇫🇷
Article L5438-2

Le fait pour le fabricant, l’importateur ou le distributeur d’excipients tels que définis par l’article L. 5138-2 d’exercer son activité sans avoir effectué la déclaration auprès de l’Agence nationale de sécurité du médicament et des produits de santé dans les conditions fixées à l’article L. 5138-1 est puni d’un an d’emprisonnement et de 75 000 € d’amende.

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