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Article L5421-6-1 of the French Public Health Code

Any person exploiting a medicinal product or product mentioned in Article L. 5121-1 or any holder of the authorisation provided for in Article L. 4211-6 who fails to comply with the obligations to report a serious adverse reaction suspected to be due to this medicinal product or product of which he has been made aware is liable to two years’ imprisonment and a fine of €150,000.

Original in French 🇫🇷
Article L5421-6-1

Le fait pour toute personne exploitant un médicament ou produit mentionnés à l’article L. 5121-1 ou pour tout titulaire de l’autorisation prévue à l’article L. 4211-6 de méconnaître les obligations de signalement d’un effet indésirable grave suspecté d’être dû à ce médicament ou produit dont il a eu connaissance est puni de deux ans d’emprisonnement et de 150 000 € d’amende.

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