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 9991–10000 of 32584 articles for “Art. Cass. 1ère civ. 9-7-2014 n° 13-15.948”
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…
The Agence nationale de sécurité du médicament et des produits de santé publishes on its website : 1° The initial compassionate prescribing framework, the protocol for therapeutic use and patient foll…
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…
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 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…
I. - Except when the Agence nationale de sécurité du médicament et des produits de santé makes use of the derogation mentioned in V of article L. 5121-12-1, the compassionate prescription framework is…
The compassionate prescribing framework drawn up by the Director General of the Agence nationale de sécurité du médicament et des produits de santé states in particular, for each medicinal product: 1°…
The société de participations financières de profession libérale de pharmaciens d'officine shall inform the director general of the regional health agency, in whose area of jurisdiction the registered…
For the application of the provisions mentioned in article R. 5125-33-6, the pharmacist shall respect the confidentiality of discussions with the patient. To this end, he must have at his disposal pre…
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