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Showing 7621–7630 of 47092 articles for “Art. L. 311-4”
…s well as an attestation certifying that the dossiers submitted in each of these States are identical. Any application to vary a marketing authorisation granted in application of one of these procedur…
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…
…n group mentioned in Article 31 of Directive 2001/82/EC of the European Parliament and of the Council.
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…
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…
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