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Showing 3561–3570 of 21284 articles for “Art. BOFiP-BIC-CHAMP-40-10-§§ 115 et 165”
…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…be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medicinal product no longer satisfies the conditions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…
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent for a period of forty-five days from the date of receipt of the complete application a…
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…
…ired for biomedical research, a document drawn up by the Agence nationale de sécurité du médicament et des produits de santé, certifying that the imported medicinal product is intended for research au…
The holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
When the marketing authorisation for the proprietary medicinal product that has been granted a marketing authorisation in France is amended by the Director General of the Agence nationale de sécurité…
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