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Showing 2081–2090 of 57921 articles for “Art. L 54-10-2”
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…
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…
The creation, organisation and funding of veterinary pharmacovigilance centres, as well as the conditions under which they carry out the tasks entrusted to them by the Agence nationale de sécurité san…
For the application of the second paragraph of article L. 1441-4, the seats are allocated in proportion to the number of member companies and employees obtained in application of articles R. 1441-8 an…
I. - The banking and payment services intermediaries referred to in 2° and 3° of the I of article R. 519-4 and their agents referred to in 4° of the same I, carrying out an intermediation activity in…
…a serious or unexpected adverse reaction which may be attributed to the use of a veterinary medicinal product, whether or not he has prescribed it, or a medicinal product for human use administered to…
A company operating a veterinary medicinal product must: 1° Keep detailed records of all suspected adverse reactions which have occurred inside or outside the European Union; 2° To record any suspecte…
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…
The procedures and standard form for the declarations and the periodic pharmacovigilance update report mentioned in articles R. 5141-103 to R. 5141-105-1 are laid down by decision of the Director Gene…
Without prejudice to the conditions laid down when the marketing authorisation is granted pursuant to the provisions of the fourth paragraph of Article L. 5141-5, the company operating the veterinary…
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