Article R5121-76-10
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…
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Showing 4701–4710 of 28297 articles for “Art. Cass. 3e civ. 7-7-2016 n° 15-12370”
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…
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…
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…
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
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 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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