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Showing 7341–7350 of 55286 articles for “Art. s. 389 et 389-1”
…accordance with the provisions of Decree No. 2017-1416 of 28 September 2017 on electronic signatures.The decision to refuse, suspend or withdraw an authorisation may also be sent under these conditio…
…ssued to a legal entity. It is not transferable. Authorisations are valid for a maximum of five years. II - The application for renewal of the authorisation is sent by the holder to the Director Gener…
…r authorisation addressed to the Director General of the Agence nationale de sécurité du médicament et des produits de santé under the conditions mentioned in Articles R. 5139-3 to R. 5139-7 . Failure…
For the purposes of this chapter, "establishment" means any place or site where one or more operations involving micro-organisms and toxins or products containing them are carried out.
…o an authorisation issued by the Director General of the Agence nationale de sécurité du médicament et des produits de santé, without prejudice to the provisions of Title III of Book V of the Environm…
…n 1° of Article R. 5139-3 up to date and sends it to the Agence nationale de sécurité du médicament et des produits de santé by 15 February each year at the latest. Any change to this list during the…
…nder the conditions referred to in 3° of Article R. 5139-20 and designed to guarantee biological safety and security. The following definitions apply 1° Biological safety: all measures and practices a…
The application for marketing authorisation is accompanied by a dossier containing : 1° The administrative information required to examine the application ; 2° Scientific documentation demonstrating t…
The application for marketing authorisation for a veterinary medicinal product shall be sent to the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement…
…sion of the dossier, presented in summary form and concluding with an analysis of the relationship between the benefits and the risks associated with the use of the veterinary medicinal product. Each…
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