Article R5121-76-1
The purpose of the compassionate prescribing framework referred to in Article L. 5121-12-1 is to ensure the safety of prescribing a medicinal product which does not comply with its marketing authorisa…
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Showing 4931–4940 of 38937 articles for “Art. 815-3 al. 7”
The purpose of the compassionate prescribing framework referred to in Article L. 5121-12-1 is to ensure the safety of prescribing a medicinal product which does not comply with its marketing authorisa…
I. - If required for public health reasons, in the event of a breach of the obligation to monitor patients and collect information, or if the conditions set out in Article L. 5121-12-1 are no longer m…
…édicament et des produits de santé or on expiry of the period provided for in II of Article R. 5121-76-11, the Minister for Defence may grant the authorisation for use provided for in Article R. 5121-…
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…
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.-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…
The data referred to in II and III of Article R. 5121-201-5 and a copy of the administration record referred to in Article R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5…
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