Article R5121-195
The registers or records provided for in articles R. 5121-185 to R. 5121-193 are kept for a period of forty years. Where necessary for the purposes of pharmacovigilance, the regional pharmacovigilance…
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Showing 2261–2270 of 5368 articles for “Art. 13 juill. 2010”
The registers or records provided for in articles R. 5121-185 to R. 5121-193 are kept for a period of forty years. Where necessary for the purposes of pharmacovigilance, the regional pharmacovigilance…
When the in-house pharmacy dispenses a blood-derived medicinal product directly to a patient, the information referred to in article R. 5121-187 is transcribed onto a special register marked and initi…
…for in this paragraph take the place of the transcriptions and recordings mentioned in article R. 5132-10.
When a healthcare professional administers a blood-derived medicinal product outside healthcare establishments or the establishments and organisations mentioned in article R. 5121-192, he/she affixes…
In blood transfusion establishments and in any organisation other than pharmacies, health establishments and health cooperation groups authorised to dispense blood-derived medicinal products, these me…
Pharmacovigilance of blood-derived medicinal products involves monitoring, known as traceability, from the time they are manufactured until they are administered to patients. The purpose of this monit…
In healthcare establishments and other establishments with an in-house pharmacy, blood-derived medicinal products are dispensed by the in-house pharmacy on the basis of a medical prescription.The in-h…
…lood-derived medicinal product must immediately transcribe the information mentioned in article R. 5132-10, the patient's date of birth and the information appearing on the detachable label of the out…
A pharmaceutical establishment manufacturing, operating, importing, exporting or wholesaling blood-derived medicinal products must, when disposing of these medicinal products, record :1° The name, str…
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…
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