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Showing 4771–4780 of 11768 articles for “Art. CE 15-10-1982 n° 26585”
…the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medicinal product no longer s…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…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, the authorisation will be refused on expiry of a period of forty-five days from the d…
…other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate access authorisation under II of article L. 5121-12-1 granted for an imported medicinal product or a c…
…tary medicinal product constitutes a parallel import with a view to placing it on the market in France: 1° Which comes from another Member State of the European Community or party to the Agreement on…
…isation for the proprietary medicinal product in the Member State of origin of the marketing in France of the proprietary medicinal product, prior to its marketing. It also provides the marketing auth…
…sation for the proprietary medicinal product that has been granted a marketing authorisation in France is amended by the Director General of the Agence nationale de sécurité du médicament et des produ…
…r each parallel import operation, the authorisation holder notifies the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the batch numbers of the authoris…
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