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Showing 3081–3090 of 8626 articles for “Art. 10 sept. 2020”
The declaration provided for in the fourth 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…
The application must be accompanied by : 1° For medicinal products imported for research involving the human person, an acknowledgement of receipt of the application sent to the Agence nationale de sé…
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…
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…
The provisions of this section apply to the import and export of : 1° Medicinal products classified as narcotics or to which the narcotics regulations apply in whole or in part ; 2° Medicinal products…
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…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
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…
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