Article R1243-15
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…
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Showing 41–50 of 38628 articles for “Art. L 1243-11”
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 authorised establishment or body shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of the name of one or more medical officers to whom th…
Where the activities referred to in article R. 1243-49 are carried out in separate locations, the organisation may submit several declarations, determining the scope covered by each of them.
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.
I.-The provisions of this section apply to the activities mentioned in Article L. 1243-2 relating to the preparation, preservation, distribution or transfer of tissues, their derivatives, cells or cel…
Where the activities referred to in article R. 1243-57 are carried out in separate locations, the organisation may submit several applications for authorisation, determining the scope covered by each…
Authorisations are issued for a period of five years. Applications for renewal must be accompanied by the supporting documents mentioned in article R. 1243-60 and an activity report. It is made under…
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…
…ay 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 product…
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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