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Showing 7311–7320 of 24448 articles for “Art. 4 Dec 2018”
…icles 36 to 38 of Directive 2001/82/EC of the European Parliament and of the Council when divergent decisions have been taken by Member States of the European Union concerning the authorisation, varia…
…leaflet, sent by the reference State, the Director General of the Agency has ninety days to reach a decision: 1° If the Director General of the Agency approves these documents, he shall inform the ref…
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…
…er to the European Medicines Agency for application of the Community arbitration procedure before a decision is taken on the granting, variation, suspension or withdrawal of the marketing authorisatio…
…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 sanitaire de l'al…
…of forty-five days from the date of receipt of the complete application referred to in Article R. 5141-123-3. The period mentioned in the previous paragraph is reduced to twenty days if the applicatio…
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…
…in order to check compliance with the provisions of this Title. For Class I medical devices, the EC declaration of conformity procedure, a complete quality assurance system, applies only to medical de…
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