Article R5121-201-6
…ion: 1° The name of the advanced therapy medicinal product prepared on an ad hoc basis; 2° The name and address of the establishment or body mentioned in Article L. 4211-9-1 or the pharmaceutical esta…
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Showing 4931–4940 of 58742 articles for “Art. s. 1844-11 and 1844-13”
…ion: 1° The name of the advanced therapy medicinal product prepared on an ad hoc basis; 2° The name and address of the establishment or body mentioned in Article L. 4211-9-1 or the pharmaceutical esta…
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…
…e L. 1121-1. This traceability supplements the requirements relating to the traceability of tissues and cells mentioned in Article R. 1211-19 and in the good practices provided for in Article L. 1245-…
Blood establishments 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 i…
…1 or any pharmaceutical establishment referred to in Articles L. 5124-1 or L. 5124-9-1 shall set up and keep up to date a system ensuring the traceability of advanced therapy medicinal products prepar…
In the event of interruption or cessation of activity of an establishment or organisation mentioned in article L. 4211-9-1, the data relating to the traceability of advanced therapy medicinal products…
The data referred to in II and III of Article R. 5121-201-5 and a copy of the administration record referred to in Article R. 5121-201-6 shall be kept by the establishments referred to in Article R. 5…
The correspondent mentioned in article R. 5121-181 who receives the report provided for in article R. 5121-196 immediately forwards it to the regional pharmacovigilance centre. If he is otherwise awar…
Organisations or companies exploiting blood-derived medicinal products which have knowledge of adverse reactions likely to be due to these medicinal products inform the Director General of the Agence…
…ion grouping, to the regional pharmacovigilance centre, if it is located within this establishment, and to the correspondent mentioned in article R. 5121-181 in other cases; 2° When the medicinal prod…
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