Article R5121-157
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, in…
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Showing 3601–3610 of 9503 articles for “Art. CJEU – C-593/21 – 13 Oct. 2022”
I.-The Director General of the Agence nationale de sécurité du médicament et des produits de santé, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, in…
In health establishments and health cooperation groups authorised under article L. 6133-7 to carry out the tasks of these establishments which do not have an in-house pharmacy which hold blood-derived…
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…
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