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Showing 5331–5340 of 14253 articles for “Art. CE 27-7-2012 n° 337656”
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…
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…
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé publishes, on the Agency's website, a reference database of medicinal products which are the subject…
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…
…es, the holder of the exploitation rights for a medicinal product benefiting from a compassionate access authorisation or, where applicable, his authorised representative, sends the Director General o…
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°…
…ts referred to in Article R. 5121-201-5 for at least thirty years after the expiry date of the advanced therapy medicinal product prepared on an ad hoc basis.
…he director general of the regional health agency, in whose area of jurisdiction the registered office of the company is located, and the president of the competent professional body, within thirty da…
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