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Showing 5531–5540 of 12814 articles for “Art. T. confl. 13-10-2014 n° 3963”
…1 or article L. 5124-9-1, which is responsible for preparing and distributing this medicinal product. When the medicinal product has not been administered to the patient, the healthcare professional…
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, to the administration of the individually prepared advanced therapy medicinal product to a patient. This traceability also applies to the research referred to in Article L. 1121-1. This traceabilit…
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…
…ts components used for the manufacture of each punctually prepared advanced therapy medicinal product. This data concerns : 1° Identification of the sampling establishment; 2° The sampling department;…
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…
When a person authorised to prescribe, dispense or administer medicinal products becomes aware of an adverse reaction which may be due to a blood-derived medicinal product, he/she shall report it imme…
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