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Article R5121-38 of the French Public Health Code

The Minister for Health may, on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products, require by order that companies exploiting certain immunological medicinal products mentioned in article L. 5121-1 submit to the National Agency for the Safety of Medicines and Health Products a copy of all control reports signed by the responsible pharmacist.

Original in French 🇫🇷
Article R5121-38

Le ministre chargé de la santé peut, sur proposition du directeur général de l’Agence nationale de sécurité du médicament et des produits de santé, exiger par arrêté que les entreprises exploitant certains médicaments immunologiques mentionnés à l’article L. 5121-1 soumettent à l’Agence nationale de sécurité du médicament et des produits de santé une copie de tous les comptes rendus de contrôle signés par le pharmacien responsable.

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