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Showing 3091–3100 of 64426 articles for “Art. s. L 623-10 and L 623-21”
…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…
I.-For the nuclear activities referred to in Article L. 1333-10, the person responsible for the nuclear activity and, where applicable, the head of the establishment when a different person is involve…
Notwithstanding Article R. 8115-2, when the Regional Director for Business, Competition, Consumer Affairs, Labour and Employment decides to impose an administrative fine on the basis of Articles L. 47…
I. - The provisions of section 1 of chapter V of this title are applicable to the territorial public health establishment of Saint-Pierre-et-Miquelon with the exception of articles R. 6145-21 and R. 6…
The crematorium is subject to a compliance inspection by an inspection body accredited for these activities by the French Committee for Accreditation (COFRAC) or by any other accreditation body that i…
The thresholds provided for in the first paragraph of Article L. 22-10-36, assessed on the closing date of the financial year, are set at 20 million euros for the balance sheet total, 40 million euros…
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