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Showing 361–370 of 1263 articles for “Art. 74”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé shall refuse authorisation for compassionate access if the conditions laid down in I, II and V of Articl…
Any measures taken by the holder of the exploitation rights to disseminate any information relating to the compassionate access authorisation from which it benefits to the healthcare professionals con…
I.- When examining any request for authorisation for compassionate access, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has the prerogatives set out…
In order to be able to continuously assess the benefit/risk balance of the medicinal product, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may at any…
I.-The granting of a compassionate access authorisation is subject to the establishment by the Agence nationale de sécurité du médicament et des produits de santé of a therapeutic use and patient moni…
I.-When a medicinal product, which is the subject of a compassionate access authorisation, obtains a marketing authorisation, the Director General of the Agence nationale de sécurité du médicament et…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or withdraw a compassionate access authorisation if the conditions laid down in I, II and V…
I.-The compassionate access authorisation may be renewed. Renewal is the subject of a request from the holder of this authorisation addressed to the Director General of the Agence nationale de sécurit…
Where the therapeutic use and patient monitoring protocol so provides, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where appl…
…ther free of charge or for consideration, in France, outside the collectivities governed by Article 74 of the Constitution, New Caledonia, the French Southern and Antarctic Lands and Clipperton Island…
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