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Showing 2581–2590 of 63520 articles for “Art. IV and V”
I.-Any marketing authorisation holder and any pharmaceutical company exploiting a medicinal product in France shall build up a safety stock intended for the national market referred to in article L. 5…
Research organised and carried out on human beings with a view to developing biological or medical knowledge is authorised under the conditions set out in this Book and is hereinafter referred to as "…
Pharmaceutical establishments and establishments authorised under articles L. 4211-9-1 and L. 4211-9-2 may procure tissues, their derivatives and cells from the human body, whatever their level of pro…
Manufacturers of in vitro diagnostic medical devices may procure tissues, their derivatives and cells from the human body, whatever their level of processing, in a Member State of the European Union o…
The application for authorisation provided for in III of Article L. 1245-5 shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé, by any mean…
…II. - He may request any additional information he considers necessary, by any means capable of providing a definite date for this request. In this case, the time limit stipulated in the previous par…
…Agence nationale de sécurité du médicament et des produits de santé has a period of four months to evaluate the information provided. At the end of these maximum four months, when, in application of t…
…a must send the Agence nationale de sécurité du médicament et des produits de santé, before they leave national territory, a dossier containing the following information:1° The precise designation of…
I. - The application for authorisation provided for in the second paragraph of I of Article L. 1245-5 for products from Member States of the European Union or parties to the Agreement on the European…
…will send a copy of the dossier to the Director General of the Agence de la biomédecine, who will give his opinion within one month. If no response is received within this period, this will be deemed…
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