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Showing 4631–4640 of 12836 articles for “Art. 7 mars 2012”
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…
Any measures taken by the marketing authorisation holder or the company operating the marketing authorisation to disseminate the compassionate prescribing framework or any information relating to this…
I. - On the basis of the information referred to in article R. 5121-76-3 and the scientific knowledge available, as well as, where applicable, the information transmitted in application of article R.…
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…
Any practice of prescribing a medicinal product outside the scope of its marketing authorisation may be reported by electronic means to the Director General of the Agency, to enable him to assess the…
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…
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