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Showing 2931–2940 of 66828 articles for “Art. al. 1 and 1844-10”
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…
…rietary medicinal product which has already obtained marketing authorisation in France, as regards: 1° The period of stability, special storage precautions when these are stricter than those of the pr…
…y medicinal product which has obtained marketing authorisation in France, except that it includes : 1° The addition of the name and address of the establishment responsible for changing the packaging,…
…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 ; 2° Concerning the proprietary medicinal…
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…
…orisation shall immediately inform the holder of the marketing authorisation in the State of origin and the holder of the marketing authorisation for the medicinal product which has obtained the marke…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
…plication 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 responsi…
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