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Peuvent être préparés à partir du sang ou de ses composants :
\n
1° Des produits sanguins labiles, comprenant notamment le sang total, le plasma et les cellules sanguines d'origine humaine. A l'exception des produits sanguins labiles destinés à des recherches biomédicales, seuls peuvent être distribués ou délivrés à des fins thérapeutiques, les produits sanguins labiles dont la liste et les caractéristiques sont fixées par décision de l'Agence française de sécurité sanitaire des produits de santé, après avis de l'Etablissement français du sang, et publiée au Journal officiel de la République française.
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2° Des pâtes plasmatiques ;
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3° Des produits stables préparés industriellement, qui constituent des médicaments dérivés du sang et qui sont régis par les dispositions du livre Ier de la partie V ;
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4° Des réactifs de laboratoire dont les conditions de mise sur le marché sont fixées par le titre II du livre II de la cinquième partie ;
\n
5° Des produits cellulaires à finalité thérapeutique mentionnés à l'article L. 1243-1 ;
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6° Des produits thérapeutiques annexes tels que définis à l'article L. 1261-1 ;
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7° Des excipients à usage pharmaceutique et des substances utilisées lors de la fabrication d'un médicament mais n'entrant pas dans sa composition.
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Le sang et ses composants, qu'ils aient ou non été prélevés dans des établissements de transfusion sanguine, peuvent également être utilisés pour effectuer les contrôles de qualité des analyses de biologie médicale ainsi que pour la réalisation et le contrôle des dispositifs médicaux de diagnostic in vitro, ou pour effectuer sur les produits préparés à partir du sang ou de ses composants les expertises et les contrôles techniques réalisés par l'Agence française de sécurité sanitaire des produits de santé en application du 1° de l'article L. 5311-2. Les principes mentionnés aux articles L. 1221-3, L. 1221-4 et L. 1221-6 sont également applicables dans ce cas.
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Les produits sanguins labiles proposés en vue de leur inscription sur la liste mentionnée au 1° de l'article L. 1221-8 font l'objet d'une évaluation par l'Agence française de sécurité sanitaire des produits de santé, au vu d'un dossier dont le contenu est fixé par décision de l'Agence et qui peut être fourni par l'Etablissement français du sang, le Centre de transfusion sanguine des armées, tout établissement de transfusion sanguine des Etats membres de l'Union européenne ou tout fabricant de dispositifs médicaux.
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L'Agence procède en tant que de besoin à la réévaluation des produits inscrits sur la liste. Elle peut demander à cet effet des informations à l'Etablissement français du sang, au Centre de transfusion sanguine des armées, à tout établissement de transfusion sanguine des Etats membres de l'Union européenne ou aux fabricants de dispositifs médicaux concernés.
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Article 8 ENTIEREMENT_MODIF (Ordonnance n° 2005-1087 du 1er septembre 2005 relative aux établissements publics nationaux à caractère sanitaire et aux contentieux en matière de transfusion sanguine)