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Showing 8481–8490 of 66662 articles for “Art. 1251 and 1251-1”
…horised company within the meaning of Article 77 of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human…
For pharmaceutical products with a parallel import authorisation, Customs officers check the import authorisation number on the packaging. If this number does not appear on the packaging at the time o…
…o the importing State. This declaration is accompanied by a file containing : 1° The name, strength and pharmaceutical form of the medicinal product; 2° Its therapeutic indications; 3° Its presentatio…
…nationale de sécurité du médicament et des produits de santé as provided for in articles L. 1123-8 and R. 1123-30 ; however, where the implementation of the research is of an urgent nature, this docu…
The proprietary medicinal product for which parallel import authorisation is sought may differ from the proprietary medicinal product which has already obtained marketing authorisation in France, as r…
…s obtained marketing authorisation in France, except that it includes : 1° The addition of the name and address of the establishment responsible for changing the packaging, in addition to the informat…
…e de sécurité du médicament et des produits de santé. It must state : 1° The name or corporate name and address of the applicant ; 2° Concerning the proprietary medicinal product which has obtained ma…
…A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a sample of the proprietary medicinal product marketed in the country of origin, which is intend…
The provisions of this section apply to the import and export of : 1° Medicinal products classified as narcotics or to which the narcotics regulations apply in whole or in part ; 2° Medicinal products…
…orisation shall immediately inform the holder of the marketing authorisation in the State of origin and the holder of the marketing authorisation for the medicinal product which has obtained the marke…
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