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Showing 9961–9970 of 61978 articles for “Art. R 581-30 and R 581-33”
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…
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 holder of a parallel import authorisation notifies the holder of the marketing authorisation for the proprietary medicinal product in the Member State of origin of the marketing in France of the p…
For each parallel import operation, the authorisation holder notifies the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the batch numbers of the author…
The proprietary medicinal product benefiting from a parallel import authorisation is subject to the provisions of the marketing authorisation for the proprietary medicinal product which obtained the m…
The operation, as defined in the second paragraph of 3° of Article R. 5124-2, of a proprietary medicinal product benefiting from a parallel import authorisation is carried out by the holder of this au…
When, in application of the second paragraph of Article L. 5124-11, the Director General of the Agence nationale de sécurité du médicament et des produits de santé intends to prohibit the export of a…
The authorisation to open, provided for in the first paragraph of Article L. 5124-3, a pharmaceutical establishment, a company or a body mentioned in Article R. 5124-2 is issued by the Director Genera…
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