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Showing 4821–4830 of 27949 articles for “Art. Aut. conc. n° 12-DCC-83 du 13 Jun 2012”
…n 28 September 1994 and by its third amendment signed in Paris on 11 July 2001, approved by the loi n° 2002-1305 du 29 octobre 2002 and published by the decree no. 2002-1500 of 20 December 2002;b) Agr…
…When it concerns local authority civil servants, it is provided under the conditions set by the loi n° 84-594 du 12 juillet 1984 relative à la formation des agents de la fonction publique territoriale…
Before administering the punctually prepared advanced therapy medicinal product, the health professional in the health establishment must ensure that the information required for the traceability of t…
The regional pharmacovigilance centres inform the Agence nationale de sécurité du médicament et des produits de santé on the same day of the reports of adverse reactions likely to be due to a blood-de…
The pharmacovigilance carried out on individually prepared advanced therapy medicinal products includes monitoring to ensure traceability between the various stages, from the removal of tissues, cells…
…stablishments and organisations or companies manufacturing or exploiting blood-derived medicinal products which are aware of information likely to cast doubt on the quality of blood or plasma intended…
…hall set up and keep up to date a system ensuring the traceability of advanced therapy medicinal products prepared on an ad hoc basis. II - Establishments which prepare punctually prepared advanced th…
…oned in article L. 4211-9-1, the data relating to the traceability of advanced therapy medicinal products prepared on an ad hoc basis are transferred to the establishment or organisation authorised un…
…R. 5121-201-5 for at least thirty years after the expiry date of the advanced therapy medicinal product prepared on an ad hoc basis.
…the regional pharmacovigilance centre. If he is otherwise aware of an adverse reaction likely to be due to a blood-derived medicinal product, he shall report it immediately to the regional centre. Whe…
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