Article R5141-10
Each trial gives rise to a report drawn up by the investigator who carried it out. This report is dated and signed and includes : 1° The identity of the investigator(s) or investigator(s), their quali…
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Showing 4991–5000 of 30455 articles for “Art. Cass. 1ère civ. avis 20-10-2022 n° 22-70.011 B”
Each trial gives rise to a report drawn up by the investigator who carried it out. This report is dated and signed and includes : 1° The identity of the investigator(s) or investigator(s), their quali…
A veterinarian who has observed, or to whom has been reported, a serious or unexpected adverse reaction which may be attributed to the use of a veterinary medicinal product, whether or not he has pres…
…he use of veterinary medicinal products, as well as any suspected transmission of infectious agents by veterinary medicinal products, of which he is aware or which has been brought to his attention an…
…principles of good veterinary pharmacovigilance practice to which veterinarians, pharmacists and members of the other health professions mentioned in 4° of article R. 5141-93 are subject are defined,…
Veterinary pharmacovigilance centres are responsible for : 1° Receiving reports sent, in application of article R. 5141-103, by veterinarians, pharmacists and any member of a health profession or any…
The declaration and reporting obligations laid down in this section apply without prejudice to those laid down for veterinary medicinal products authorised by the European Medicines Agency in Regulati…
…ic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director General of the Agence nationale de sécurité sanitaire de l'alimentation,…
A company operating veterinary medicinal products has at its disposal, on a permanent basis, the services of a person, pharmacist or veterinarian, responsible for veterinary pharmacovigilance residing…
…vigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail, a…
…neral of the Agence nationale de sécurité du médicament et des produits de santé or the Prefect had been informed in accordance with the procedure laid down in Articles R. 5142-6 or R. 5142-7, they wi…
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