Article R5212-6
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform without delay of any incident or risk of incident defined in Article L. 5212-2:the Etabliss…
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Showing 10801–10810 of 39241 articles for “Art. al. 6”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall inform without delay of any incident or risk of incident defined in Article L. 5212-2:the Etabliss…
For medical devices, the list of which is set by order of the Minister for Health on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé (Fr…
The certificate is issued by the person responsible for transferring the second-hand medical device to the transferee.
The content and methods of presentation of the declaration are laid down, on a proposal from the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by order o…
The declarations provided for in Articles L. 5211-3-1 and R. 5211-65 as well as the communication provided for in Article R. 5211-66 are made to the Agence nationale de sécurité du médicament et des p…
Where the authorised body encounters difficulties in implementing the conformity assessment procedures, it shall refer the matter to the Director General of the Agence nationale de sécurité du médicam…
…o not apply to the public health inspecting pharmacists and veterinarians mentioned in article R. 206-1 and in 2° of the I of article R. 231-3-7 of the rural and maritime fishing code working as inspe…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail sends a warning to the company in question, together with the inspection report o…
…ntation, de l'environnement et du travail shall call in the agents mentioned in 1° of Article L. 5146-1. The Director General of the Agency may, under cover of the Director General of the Regional Hea…
The evaluation of the clinical data referred to in Article L. 5211-3-2, hereinafter referred to as the "clinical evaluation", must, taking into account any relevant harmonised standards, follow a proc…
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