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Showing 2701–2710 of 56635 articles for “Art. Decree 2023-1409 of 29-12-2023”
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…
…pplication 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 samp…
…een issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medicinal product…
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…
…roduct 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 produits de santé, the Director General wil…
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…
…tary 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 marketing au…
…tising approval for a medicinal product, as provided for in Article L. 5122-9, is made for any form of information, as defined by Article L. 5122-1, communicated to healthcare professionals authorised…
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