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Showing 13511–13520 of 39711 articles for “Art. al. 3”
The marketing authorisation is renewable on application by the holder to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail no later…
At the request of the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, the marketing authorisation holder shall examine and, where ap…
I. - For the application of 1° of article R. 5141-18 , when reference is made to published scientific literature, the experts shall justify the use of this bibliographical documentation and demonstrat…
The marketing authorisation holder submits to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail any proposed amendment to the label…
…santé may suspend or withdraw the authorisation referred to in the second paragraph of Article L. 513-11-2.
…or, depending on the form of administration, for a given volume or weight, using the common names; 3° The manufacturing batch number; 4° The marketing authorisation number; 5° The name or corporate n…
The marketing authorisation 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…
…5141-5, any variation or extension, as provided for in Chapter I of Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing aut…
…rter ; 2° The designation of the manufacturing sites, including the packaging and inspection sites; 3° The usual common name of the homeopathic stock or stocks, with reference to the European pharmaco…
In the event of a change in the classification or maximum residue limit of a pharmacologically active substance in application of Regulation (EC) No 470/2009 of the European Parliament and of the Coun…
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