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Showing 8871–8880 of 66662 articles for “Art. 1251 and 1251-1”
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…
…tion 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. 5139-1 carried…
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,…
…ter, "establishment" means any place or site where one or more operations involving micro-organisms and toxins or products containing them are carried out.
…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 products containing them is…
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…
…h the rules of good practice laid down under the conditions referred to in 3° of Article R. 5139-20 and designed to guarantee biological safety and security. The following definitions apply 1° Biologi…
…required to examine the application ; 2° Scientific documentation demonstrating the quality, safety and efficacy of the veterinary medicinal product, in particular test or trial reports relating to ph…
…to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification as regards maximum residue limits in foodstuffs of animal origin, the appli…
…e state of scientific knowledge at the time of submission of the dossier, presented in summary form and concluding with an analysis of the relationship between the benefits and the risks associated wi…
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