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Showing 4201–4210 of 52277 articles for “Art. 1112-1”
The transmission of information referred to in Articles R. 5139-4, R. 5139-5, R. 5139-12 and R. 5139-14 may be carried out electronically after affixing an electronic signature in accordance with the…
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…
I. - Any change of establishment or use of premises intended to receive micro-organisms and toxins or products containing them, or any modification of the operations provided for in the authorisation,…
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.
Any production, manufacture, transport, import, export, possession, offer, transfer, acquisition or use of the micro-organisms and toxins on the list drawn up in application of article L. 5139-1 and p…
The authorisation holder keeps the list provided for in 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 y…
The establishment in which the operations for which authorisation has been granted are carried out operates in compliance with the rules of good practice laid down under the conditions referred to in…
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…
The expert reports provided for in article R. 5141-16 consist of a critical evaluation of the various trials carried out, taking into account the state of scientific knowledge at the time of submissio…
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