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Showing 4281–4290 of 27387 articles for “Art. Aut. conc. n° 14-DCC-167 du 13 Nov 2014”
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…
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…
For the purposes of this sub-section, army hospitals and the army blood transfusion centre are regarded as public health establishments and blood transfusion establishments respectively.
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