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Showing 4671–4680 of 11432 articles for “Art. CE 17-10-1990 n° 56991”
If the Director General of the Agence nationale de sécurité du médicament et des produits de santé remains silent, the authorisation will be refused on expiry of a period of forty-five days from the d…
…other than personal transport, referred to in article R. 5121-109, or a copy of the compassionate access authorisation under II of article L. 5121-12-1 granted for an imported medicinal product or a c…
…tary 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 or party to the Agreement on…
…isation for the proprietary medicinal product in the Member State of origin of the marketing in France of the proprietary medicinal product, prior to its marketing. It also provides the marketing auth…
…sation for the proprietary medicinal product that has been granted a marketing authorisation in France is amended by the Director General of the Agence nationale de sécurité du médicament et des produ…
…r 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 authoris…
…thorisation for the proprietary medicinal product which obtained the marketing authorisation in France relating to:-the summary of product characteristics, with the exception of the stability period a…
I.- Articles R. 5121-133 to R. 5121-135 do not apply to gene therapy and xenogenic cell therapy preparations. II-Any gene therapy or xenogenic cell therapy preparation that does not have the authorisa…
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…
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