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Showing 3551–3560 of 21284 articles for “Art. BOFiP-BIC-CHAMP-40-10-§§ 115 et 165”
…or during the authorisation period. Renewal of the authorisation is granted under the conditions set out in Articles R. 5121-116 and R. 5121-123. If the Director General of the Agence nationale de s…
…cle L. 5124-11 are issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé. These certificates are valid for three years.
…reasons for not doing so, parallel import authorisation is granted if the following conditions are met: 1° The proprietary medicinal product is obtained from an authorised company within the meaning o…
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…
…rth paragraph of Article L. 5124-11 shall be sent to the Agence nationale de sécurité du médicament et des produits de santé by any means capable of providing a date certain by the exporting pharmaceu…
…cknowledgement of receipt of the application sent to the Agence 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 i…
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…
The package leaflet of the proprietary medicinal product benefiting from a parallel import authorisation is identical to that of the proprietary medicinal product which has obtained marketing authoris…
…ort 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 name and address of the applicant…
…r 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 sample of the pro…
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