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Showing 3821–3830 of 10142 articles for “Art. CJEU – Ingmar – 9 Nov. 2000 – C-381/98”
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
I.-The period of traditional medical use provided for in 4° of Article L. 5121-14-1 is thirty years, including at least fifteen years in a Member State of the European Community or in another State pa…
Where the application for registration concerns a product which has been the subject of a Community herbal monograph established by the Committee for Herbal Medicinal Products of the European Medicine…
…ase basis, specific measures to limit it are envisaged; 8° Description of the manufacturing method; 9° Therapeutic indications, contra-indications and adverse reactions; 10° Explanation of the precaut…
…or which has been brought to their attention or any other information mentioned in article R. 5141-90 which has been brought to their attention. The same applies to any member of a healthcare profess…
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 holder of an authorisation referred to in Article L. 5141-12 must report to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail,…
The company exploiting a veterinary medicinal product may not communicate to the public information on this veterinary medicinal product relating to pharmacovigilance without transmitting it, beforeha…
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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