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Article R5121-199 of the French Public Health Code

Organisations or companies exploiting blood-derived medicinal products which have knowledge of adverse reactions likely to be due to these medicinal products inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé under the conditions set out in articles R. 5121-171 to R. 5121-173.

Original in French 🇫🇷
Article R5121-199

Les organismes ou entreprises exploitant des médicaments dérivés du sang qui ont connaissance d’effets indésirables susceptibles d’être dus à ces médicaments en informent le directeur général de l’Agence nationale de sécurité du médicament et des produits de santé dans les conditions prévues aux articles R. 5121-171 à R. 5121-173.

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