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Showing 4281–4290 of 24560 articles for “Art. Cass. com. – 21 June 2011 – no. 10-19.902”
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…
…for changing the packaging, in addition to the information provided for in e of 1° of Article R. 5121-149; 2° The full qualitative composition of excipients where this differs from that of the propri…
…by weight, volume or number of dosage units, as well as the name within the meaning of Article R. 5121-1 and the contents of the packaging of the proprietary medicinal product as it will be marketed i…
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…
…rketing authorisation in France of any serious adverse reaction, within the meaning of Article R. 5121-153, concerning the imported medicinal product, as soon as he is aware of it. It will also inform…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
…herapy 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…
…in that they include : 1° The addition, in addition to the information provided for in Article R. 5121-138, of the name and address of the establishment responsible for modifying the packaging ; 2° Th…
…days from the date of receipt of the complete application and dossier referred to in Articles R. 5121-120 and R. 5121-121, authorisation of the parallel import will be refused. This time limit is ext…
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