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Showing 9741–9750 of 42843 articles for “Art. R 134-4”
I. - The role of the person responsible for quality control in the blood establishment involves checking that labile blood products, medical devices and equipment comply with pre-established standards…
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…
Establishments or organisations benefiting from the authorisation referred to in Article R. 1243-6 may sell tissues, their derivatives, cells or cell therapy preparations to manufacturers of in vitro…
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…
The establishments or organisations benefiting from the authorisation referred to in Article R. 1243-6 may transfer tissues, their derivatives, cells or cell therapy preparations to a pharmaceutical p…
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