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Showing 7461–7470 of 47019 articles for “Art. L 145-4”
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, 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…
At the end of the Community arbitration procedure implemented in accordance with the provisions of Articles R. 5141-47-9 to R. 5141-47-11, the Director General of the Agence nationale de sécurité sani…
Silence on the part of the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall constitute refusal of authorisation on expiry of a p…
For each batch of medicinal products referred to in articles R. 5142-45 and R. 5142-46, the pharmacist or veterinarian responsible shall release the batches and certify that each manufacturing batch c…
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…
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