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Showing 901–910 of 61408 articles for “Art. 422-218 to 422-220 and 422-230 to 422-231”
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…
…tes authorisation, for the manufacturers of pharmaceutical products mentioned in article R. 5124-2, to carry out the activities mentioned in article R. 1243-1, with the exception of those of distribut…
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.
Any import or export of organs, excluding transit, is subject to the following information being affixed to the package: 1° The words: "elements or products of human origin" ; 2° The designation of th…
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…
The importer of organs shall ensure that they have been removed with the donor's prior consent and without any payment, in whatever form, having been made to the donor. He must be able to justify that…
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…
…ll therapy preparations are distributed under the responsibility of the responsible person referred to in Article R. 1243-12 or, where applicable, the person responsible for the activities referred to…
…s or the cell therapy preparations are accompanied by the documents mentioned in Article R. 1211-19 and Article R. 1211-22-2 and in the rules of good practice provided for in Article L. 1245-6, which…
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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