Article R122-2
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Showing 8671–8680 of 55418 articles for “Art. Cass. 3e Civ. 2-4-2003 n° 490”
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Subject to the provision of the second paragraph relating to blood establishments, the establishment or authorised body shall set up a scientific council or a medico-technical committee, responsible i…
By way of derogation from the provisions of this section, where the tissues, their derivatives or the cells or cell therapy preparations are intended for the manufacture of a proprietary medicinal pro…
An analytical accounting system covering the economic, financial and accounting data relating to the activities mentioned in article R. 1243-1 is set up within the establishment or authorised body.
The authorised establishment or body sends the Director General of the Agence nationale de sécurité du médicament et des produits de santé and the Director General of the Agence de la biomédecine, as…
Authorised establishments or organisations shall make available to the Agence nationale de sécurité du médicament et des produits de santé updated data concerning staff, equipment and any information…
Tissues or their derivatives or cell therapy preparations are distributed under the responsibility of the responsible person referred to in Article R. 1243-12 or, where applicable, the person responsi…
When they are distributed or transferred, the tissues, their derivatives, the cells or the cell therapy preparations are accompanied by the documents mentioned in Article R. 1211-19 and Article R. 121…
An establishment or an authorised body may transfer tissues, their derivatives or cells or cell therapy preparations to another establishment or authorised body with a view to their preparation, prese…
Establishments and authorised organisations shall implement a procedure for the recall of tissues or their derivatives or cell therapy preparations in accordance with the rules of good practice provid…
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