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Showing 7311–7320 of 24499 articles for “Art. 4 Dec 2013”
…ing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, in more than one Member State of t…
…n or withdrawal of a marketing authorisation which he has granted following a mutual recognition or decentralised procedure is necessary for the protection of human or animal health or the environment…
…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…
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