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Showing 3121–3130 of 34670 articles for “Art. R. 145-10”
…sible 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 p…
…gin, 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 marke…
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…
…ain subject to the specific provisions relating to them respectively, which are set out in articles R. 5132-27 and R. 5132-86.
…he marketing 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 i…
After it has been issued, the parallel import authorisation may be suspended or withdrawn by the Director General of the Agence nationale de sécurité du médicament et des produits de santé if the medi…
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…
…cept 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 ;…
…five 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 i…
…five days 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 fifte…
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