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Showing 9201–9210 of 56461 articles for “Art. Cass. 1ère civ. 17-1-2006 n° 04-13.789”
Following the establishment of a new Community herbal monograph or the revision of an existing monograph, the registration holder shall submit a request for amendment of the registration dossier to th…
Where a Community herbal monograph has been established or where the herbal medicinal product consists of herbal substances, preparations or combinations thereof included in the list drawn up by the C…
If, after a traditional herbal medicinal product has been registered, the proprietor considers, on the basis of new data available to him, that, given its characteristics, the medicinal product is now…
When a herbal substance, a herbal preparation or a combination of substances is withdrawn from the list drawn up by the Commission of the European Communities, any registration of traditional herbal m…
Persons who have access to the information referred to in article R. 513-10-12 are bound by professional secrecy under the conditions set out inarticle 226-13 of the French Criminal Code.
The parallel import authorisation is issued for a period of five years. It specifies the differences mentioned in article R. 5141-123-8 with the speciality that has obtained marketing authorisation in…
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,…
For veterinary medicinal products with a parallel import authorisation as provided for in Article R. 5141-123-12, customs officers check the corresponding parallel import authorisation number on the p…
When the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail notifies the holder of the parallel import authorisation for a proprietary v…
The holder of a parallel import authorisation for a proprietary veterinary medicinal product shall immediately inform the marketing authorisation holder in the country of origin of any serious adverse…
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