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Showing 6041–6050 of 26420 articles for “Art. Cass. 3e civ. 19-11-2014 n° 13-20.089”
Vigilance includes: 1° For user healthcare professionals mentioned in Article L. 5232-4, the reporting to the Agence française de sécurité sanitaire des produits de santé of any incident consisting of…
When informed of an incident, the Director General of the Agence française de sécurité sanitaire des produits de santé will arrange for it to be assessed. As part of this assessment, he will carry out…
The purpose of the vigilance exercised over the software mentioned in 18° of Article L. 5311-1 and the devices mentioned in 19° of the same article, used in medical biology laboratories, is to monitor…
The doctor, dental surgeon, midwife, pharmacist or nurse shall immediately report any adverse reaction suspected of being due to a medicinal product or to a product mentioned in article R. 5121-150 of…
I.-Subject to the provisions of II and III, the articles mentioned in the left-hand column of the table below shall apply in New Caledonia, in the wording indicated in the right-hand column of the sam…
I.-Subject to the provisions of II and III, the articles listed in the left-hand column of the table below shall apply in French Polynesia in the wording indicated in the right-hand column of the same…
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 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…
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…
I.-Any establishment or body referred to in Article L. 4211-9-1 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…
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