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Showing 3681–3690 of 43105 articles for “Art. R. 211-4”
The following are laid down 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: 1° The list of subs…
In order to obtain a marketing authorisation for a medicinal product which is not covered by the marketing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/…
When the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail considers that the variation, suspension or withdrawal of a marketing author…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or the applicant for marketing authorisation may refer the matter to the European…
In order to obtain recognition in France of a marketing authorisation issued by another Member State of the European Union, known as the reference State, the holder of this authorisation must submit a…
In order to obtain recognition, by at least one other Member State of the European Union, of a marketing authorisation issued by the Director General of the Agence nationale de sécurité sanitaire de l…
In specific cases of Community interest, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail or the applicant shall refer the matter…
Pharmaceutical establishments carrying out one or more of the operations making up the operation must have a documentation system comprising the procedures and records covering the operations they car…
The Agency's inspectors will carry out inspections as decided by the Agency's Director General, who will issue a letter of assignment to the inspector in charge of the investigation. This letter speci…
For Class IIa devices, the authorized body must, as part of the assessment of the quality system, assess the technical documentation for at least one representative sample of each device subcategory i…
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