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Showing 13521–13530 of 39711 articles for “Art. al. 3”
…selection, tests and analyses mentioned in the rules of good practice provided for in article L. 513-11-2 are carried out in compliance with standards equivalent to these rules. II. - The establishme…
…ment et des produits de santé may suspend or withdraw the authorisation referred to in Article L. 513-11-1.
…lication for marketing authorisation in France without complying with the provisions of sub-section 3a of this section, the Director General of the Agence nationale de sécurité sanitaire de l'alimenta…
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…
…State, the other States concerned, the applicant and the coordination group referred to in Article 31 of Directive 2001/82/EC of the European Parliament and of the Council. In addition, if the Direct…
…r, for the species or species in question, in Table 1 of the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification as regar…
…technical and scientific progress under the conditions laid down in Commission Regulation (EC) No 1234/2008 of 28 November 2008 concerning the examination of variations to the terms of a marketing aut…
The natural or legal person who initiates a veterinary medicinal product trial as defined in article R. 5141-2 is called the sponsor. The persons who direct and supervise the performance of pharmaceut…
…needs. Only establishments or organisations holding the authorisation provided for in Article L. 513-11-1, pharmacies for internal use authorised under Article L. 5126-4 or pharmaceutical establishme…
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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