Article R8115-10
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…
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Showing 2311–2320 of 33133 articles for “Art. Cass. com. 10-5-1994”
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…
The medicinal products and products referred to in article R. 5126-108 are held in one or more premises, cupboards or other locked storage devices, or with a locking system that ensures the same secur…
I. - Authorisation is issued to a natural person for all or part of a strain of micro-organism or a type of toxin and for one or more of the operations mentioned in the first paragraph of Article R. 5…
Persons manufacturing or marketing the substances, plants, medicinal products and other products mentioned in article R. 5132-98 shall, at their request, provide the Director General of the Agence nat…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé provides all relevant information to the European Medicines Agency, as well as to the International Narc…
The drug dependence and addictovigilance assessment and information centres carry out their vigilance missions relating to health products under the conditions defined in article R. 1413-61-4.
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…
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