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Article L5221-6 of the French Public Health Code

Given the precautions in use and interpretation that they require, certain self-diagnostic devices mentioned in paragraph 5 of Article 2 of Regulation (EU) 2017/746 and appearing on a list set by order of the Minister for Health issued on a proposal from the Director General of the National Agency for the Safety of Medicines and Health Products may only be dispensed on medical prescription.

Original in French 🇫🇷
Article L5221-6

Compte tenu des précautions d’utilisation et d’interprétation qu’ils exigent, certains dispositifs d’autodiagnostic mentionnés au paragraphe 5 de l’article 2 du règlement (UE) 2017/746 et figurant sur une liste fixée par arrêté du ministre chargé de la santé pris sur proposition du directeur général de l’Agence nationale de sécurité du médicament et des produits de santé ne peuvent être délivrés que sur prescription médicale.

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