Brief

An inspection at Theramex France's establishment in Neuilly-sur-Seine revealed significant non-conformities and shortcomings. The French National Agency for Medicines and Health Products Safety (ANSM) issued a notice to correct these issues, including lacunes in information medical management, insuffisances in advertising management, carences in pharmacovigilance management, and more. Compliance actions were ordered to be implemented within specific deadlines, with failure to comply potentially affecting Theramex France's operations and reputation.

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French National Agency for the Safety of Medicines and Health Products (ANSM)

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