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Showing 4661–4670 of 11432 articles for “Art. CE 17-10-1990 n° 56991”
…er from the proprietary medicinal product which has already obtained marketing authorisation in France, as regards: 1° The period of stability, special storage precautions when these are stricter than…
…ical to that of the proprietary medicinal product which has obtained marketing authorisation in France, except that it includes : 1° The addition of the name and address of the establishment responsib…
The application for parallel import authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name or corporate n…
…1° 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 int…
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…
…eting authorisation for the medicinal product which has obtained the marketing authorisation in France of any serious adverse reaction, within the meaning of Article R. 5121-153, concerning the import…
…the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medicinal product no longer s…
The application for an import authorisation must be sent by any means capable of providing a date certain and must indicate : 1° The name or business name and address of the natural or legal person re…
…cal to those of the proprietary medicinal product which has obtained marketing authorisation in France, except in that they include : 1° The addition, in addition to the information provided for in Ar…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent for a period of forty-five days from the date of receipt of the complete application a…
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