Article R5121-110
…edicinal product in question that may be imported and the period during which the operations may be carried out. Importation may be prohibited by the Director General of the Agence nationale de sécuri…
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Showing 3511–3520 of 9424 articles for “Art. CA Versailles 14-11-1996”
…edicinal product in question that may be imported and the period during which the operations may be carried out. Importation may be prohibited by the Director General of the Agence nationale de sécuri…
…19, the contents of the packaging in terms of weight, volume or number of dosage units, the classification in the categories mentioned in Article R. 5121-36, the summary of product characteristics, th…
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…
…ained marketing authorisation in France, as regards: 1° The period of stability, special storage precautions when these are stricter than those of the proprietary medicinal product which has obtained…
…aflet of the proprietary medicinal product benefiting from a parallel import authorisation is identical to that of the proprietary medicinal product which has obtained marketing authorisation in Franc…
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…
…ging of the proprietary medicinal product benefiting from a parallel import authorisation are identical to those of the proprietary medicinal product which has obtained marketing authorisation in Fran…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, the authorisation will be refused on expiry of a period of forty-five days from the d…
…d at the time of inspection by customs officers.For imported medicinal products required for biomedical research, a document drawn up by the Agence nationale de sécurité du médicament et des produits…
…e quantitative and qualitative composition in terms of active substances and excipients, pharmaceutical form and therapeutic effects are identical to those of a proprietary medicinal product which has…
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