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Showing 1871–1880 of 5594 articles for “Art. 815-12”
The parallel import authorisation is granted for a period of five years. It specifies the differences mentioned in articles R. 5121-117 to R. 5121-119 with the speciality that has obtained marketing a…
The application for renewal of the parallel import authorisation must be submitted no later than three months before the expiry date of the parallel import authorisation. It must be accompanied by a d…
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…
The application for a parallel import authorisation is accompanied by a dossier comprising : 1° A sample of the proprietary medicinal product which has obtained marketing authorisation in France and a…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
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…
The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
When the marketing authorisation 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…
For 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 author…
The proprietary medicinal product benefiting from a parallel import authorisation is subject to the provisions of the marketing authorisation for the proprietary medicinal product which obtained the m…
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