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Showing 4621–4630 of 5872 articles for “Art. 11”
…Agence nationale de sécurité du médicament et des produits de santé as provided for in articles L. 1123-8 and R. 1123-30 ; however, where the implementation of the research is of an urgent nature, th…
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…
…erapy preparations, the name and address of the establishment or body authorised under Article L. 4211-8 or Article L. 4211-9; 2° The country of origin and, if different, the country of origin of the…
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…
…ys from the date of receipt of the complete application and dossier referred to in Articles R. 5121-111 and R. 5121-112. The time limit mentioned in the previous paragraph is extended by fifteen days…
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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