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Showing 391–400 of 1410 articles for “Art. 74 SE”
Article D.* 213-4 is applicable in French Polynesia in the version resulting from decree no. 2005-1006 of 2 August 2005.
…he name and contact details of the prescriber and the contact details of the pharmacy for internal use in the health establishment or of the person responsible as referred to in Article L. 5126-10 ; 2…
…rector 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 Article L. 5…
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…
…ral of the Agence nationale de sécurité du médicament et des produits de santé has the prerogatives set out in Article R. 5121-34. II.- As soon as a first request for authorisation for compassionate a…
In order to be able to continuously assess the benefit/risk balance of the medicinal product, the Director General of the Agence nationale de sécurité du médicament et des produits de santé may at any…
…shment by the Agence nationale de sécurité du médicament et des produits de santé of a therapeutic use and patient monitoring protocol. This protocol specifies in particular the indication concerned,…
…e Director General of the Agence nationale de sécurité du médicament et des produits de santé shall set the date on which the granting of these authorisations ceases. This date shall be determined hav…
…sation if the conditions laid down in I, II and V of Article L. 5121-12-1 or the provisions of this section are not complied with, or for any other public health reason. Except in cases of urgency, su…
…ion 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 sécurité du médicament et des produits de san…
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