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Showing 2351–2360 of 57736 articles for “Art. s. 1133 and 13”
…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…
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.
In authorised establishments and in liaison with their directors, the medical managers of transplant activities and those of intensive care and continuous monitoring units draw up agreements defining…
The healthcare establishment has a paediatric continuous monitoring unit; this may specialise in organ transplants in accordance with the provisions of article R. 6123-38-7. The intensive care activit…
…s at least one paediatrician who can intervene within a timeframe compatible with safety requirements. The medical and nursing staff are experienced in caring for children and include at least one nur…
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