Article R1243-11
…thorised under this same article, guaranteeing that in the event of interruption or cessation of activity, the tissues, their derivatives, the cells or the cell therapy preparations are transferred th…
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Showing 6021–6030 of 66237 articles for “Art. III and IV”
…thorised under this same article, guaranteeing that in the event of interruption or cessation of activity, the tissues, their derivatives, the cells or the cell therapy preparations are transferred th…
A copy of the complete dossier is sent by the Director General of the Agence nationale de sécurité du médicament et des produits de santé to the Director General of the Agence de la biomédecine. The D…
…produits de santé of the name of one or more medical officers to whom the staff carrying out the activities referred to in article R. 1243-1 may refer on any question relating to the medical activitie…
I.-The applicant establishments or organisations have medical, paramedical and technical staff who carry out their duties under the authority of the person in charge or the person responsible for the…
The authorisation provided for in article L. 1243-2 may cover one or more of the activities mentioned in that article.
…santé a copy of any instrument appointing the responsible person referred to in Article R. 1243-12 and any interim responsible persons. When the responsible person or the acting responsible person is…
Applicant establishments or organisations have premises that guarantee the quality and safety of tissues or their derivatives or cell therapy preparations, in accordance with the rules of good practic…
…d practice provided for in article L. 1245-6, enabling them to guarantee the quality, health safety and traceability of tissues, their derivatives or cells or cell therapy preparations and to reduce t…
…ns appoint a responsible person who ensures compliance with the regulations relating to the quality and safety of tissues or their derivatives or cell therapy preparations, as well as one or more inte…
…ication, he may suspend consideration of the application until the missing information has been received, subject to a maximum period of four months. In this case, it must notify the applicant of the…
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