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Showing 171–180 of 27157 articles for “Art. Cass. com. 9-10-2007 n° 05-22.023”
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…
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…
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…
The Director General of the Regional Health Agency appoints the head of the observatory referred to in Article R. 1413-90, for a renewable term of five years. The observatory may comprise several unit…
In each region, an observatory for medicinal products, medical devices and therapeutic innovation is responsible for the following: 1° Supporting the drafting of the contracts mentioned in article L.…
I. - Documents relating to the application of loi n° 66-509 du 12 juillet 1966 relative à l'assurance maladie et à l'assurance maternité des travailleurs non salariés des professions non agricoles, ar…
The contract provided for in article L. 224-97 includes the following information: 1° The full name and address of the professional purchaser or, in the case of a legal entity, its company name and th…
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