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Showing 3701–3710 of 21962 articles for “Art. BOFiP-IS-CHAMP-10-30-§§ 320 et 330”
…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…
…icinal products remain subject to the specific provisions relating to them respectively, which are set out in articles R. 5132-27 and R. 5132-86.
The holder of a parallel import authorisation shall immediately inform the holder of the marketing authorisation in the State of origin and the holder of the marketing authorisation for the medicinal…
…be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medicinal product no longer satisfies the conditions of the authoris…
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…
The labelling and outer packaging of the proprietary medicinal product benefiting from a parallel import authorisation are identical to those of the proprietary medicinal product which has obtained ma…
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