Article R5121-76-9
…f the conditions set out in Article L. 5121-12-1 are no longer met, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or revoke the compassion…
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Showing 5321–5330 of 14253 articles for “Art. CE 27-7-2012 n° 337656”
…f the conditions set out in Article L. 5121-12-1 are no longer met, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may suspend or revoke the compassion…
On receipt of the opinion of the Agence nationale de sécurité du médicament 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 ma…
I.- Authorisation for compassionate access is granted by the Director General of the Agence nationale de sécurité du médicament et des produits de santé for the duration of treatment of the patient in…
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…
…he holder of the exploitation rights to disseminate any information relating to the compassionate access authorisation from which it benefits to the healthcare professionals concerned must not constit…
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…
…scribing framework or any information relating to this framework to the healthcare professionals concerned must not constitute advertising within the meaning of Article L. 5122-1. These measures are s…
…l as, where applicable, the information transmitted in application of article R. 5121-76-2, the Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safe…
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…
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