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Showing 1871–1880 of 5900 articles for “Art. 494-11”
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 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, the authorisation will be refused on expiry of a period of forty-five days from the d…
The import authorisation or, for private individuals, a copy of the authorisation to import by a means other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate…
The importation of a proprietary medicinal product constitutes a parallel import with a view to placing it on the market in France: 1° Which comes from another Member State of the European Community o…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may request the applicant to provide additional information necessary for the examination of the applica…
Any change to the conditions under which the pharmacy is set up, relating to the surface area of the premises, the addition or removal of a storage room within the meaning of article R. 5125-8, altera…
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