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Showing 3101–3110 of 31982 articles for “Art. 10 May 2017”
…he authorisation to import by a means 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 fo…
…nale de sécurité du médicament et des produits de santé. However, the proprietary medicinal product may contain excipients different from those of the proprietary medicinal product which has obtained…
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…
When the marketing authorisation 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…
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…
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…
…atter has one month to submit its observations. In urgent cases, the Director General of the Agency may immediately prohibit the export for a maximum period of six months. Decisions to ban exports mus…
…his situation. This allowance is not payable in the cases mentioned in 3° and 4° of article L. 1243-10 of the Labour Code, nor in the event that the practitioner, who is on the list of suitable candid…
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