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Showing 10871–10880 of 39241 articles for “Art. al. 6”
For the purposes of Article L. 5141-5, type II variations and extensions as defined in 3° and 4° of Article 2 of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination…
…manufacturing methods and control techniques set out in the dossier provided for in Article R. 5141-64 are modified in line with scientific and technical progress.
The registration issued by the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail becomes null and void if it appears : 1° That it is not followed by the market…
Any change of registration holder is subject to authorisation from the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail. The applicati…
Where the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail considers that the application or the accompanying dossier is incomplete, h…
…eement within the coordination group, the Community arbitration procedure provided for in Articles 36 to 38 of Directive 2001/82/EC of the European Parliament and of the Council applies. Where France…
The applicant for marketing authorisation is responsible for the accuracy and sincerity of the information and data provided to the Agence nationale de sécurité sanitaire de l'alimentation, de l'envir…
…uct is intended, pharmaceutical form, method and route of administration and maximum period of use; 6° An explanation of the precautionary and safety measures to be taken when storing the veterinary m…
…re or a mutual recognition procedure for which France acts as the reference Member State is set at €6,000 and €1,000 per additional medicinal product. IV. The amount of the fee provided for in 2° of 1…
Establishments or organisations applying for the authorisation referred to in Article L. 513-11-1 have premises, staff and equipment to guarantee the quality, health safety and traceability of the fae…
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