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Showing 4701–4710 of 11432 articles for “Art. CE 17-10-1990 n° 56991”
The treatment of severe burns referred to in 9° of article R. 6122-25 consists of caring for patients suffering from burns that are serious in terms of their extent, depth or location.
…m the burns treatment facility, the authorisation holder organises the continuity of care and, if necessary, the transfer of the patient to another hospital unit. In order to enable the care of patien…
The burns treatment facility provides ongoing assistance to establishments authorised to carry out the emergency medical care activities referred to in article R. 6123-1 with a view to establishing th…
The agreements referred to in articles R. 6123-114 and R. 6123-115 specify the procedures for collaboration between the medical and paramedical teams of the establishments, in particular the procedure…
The application for authorisation is deemed to be complete if, within one month of receipt, the Director General of the Agence nationale de sécurité du médicament et des produits de santé has not info…
For the purposes of this section, advanced therapy medicinal products prepared on an ad hoc basis mean the advanced therapy medicinal products mentioned in 17° of Article L. 5121-1.For the purposes of…
The Agence de la biomédecine is informed of the decisions taken in application of Article R. 5121-212.
…e efficacy and safety of the medicinal product, including the periodic collection of information concerning efficacy and adverse reactions and the transmission of this information to the Director Gene…
I. - The application for authorisation of an individually prepared advanced therapy medicinal product is accompanied by a dossier, the content of which is laid down by decision of the Director General…
…and R. 5121-213, or where it appears, particularly following evaluation, that the benefit/risk balance of the medicinal product is not favourable or that the claimed therapeutic effect is lacking, or…
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