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Showing 5411–5420 of 12814 articles for “Art. T. confl. 13-10-2014 n° 3963”
The parallel import authorisation is granted for a period of five years. It specifies the differences mentioned in articles R. 5121-117 to R. 5121-119 with the speciality that has obtained marketing a…
…use, or for the period of treatment stipulated in the prescription prescribing the medicinal product. If they transport this medicine personally, they are exempt from authorisation. When they import…
The application for renewal of the parallel import authorisation must be submitted no later than three months before the expiry date of the parallel import authorisation. It must be accompanied by a d…
Except where there are public health reasons for not doing so, parallel import authorisation is granted if the following conditions are met: 1° The proprietary medicinal product is obtained from an au…
…s; 4° In other cases, a letter from the applicant justifying the need to import the medicinal product. In all cases, the Director General of the Agence nationale de sécurité du médicament et des produ…
…arking; 3° The composition of the excipients; 4° The date of the last revision of the package leaflet.
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 parallel import authorisation is sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé. It must state : 1° The name or corporate n…
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…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
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