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Showing 3211–3220 of 61596 articles for “Art. R 812-1 et seq.”
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…
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 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 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…
The application for marketing authorisation is accompanied by a draft summary of product characteristics, the presentation and content of which are laid down in accordance with Article 14 of Directive…
By way of derogation from the first paragraph of Article R. 5141-16, for the veterinary medicinal products mentioned in this Article, the dossier attached to the marketing authorisation application is…
The application for marketing authorisation for a veterinary medicinal product contains the following information: 1° The name or corporate name and address of the future holder of the marketing autho…
The dossiers provided in support of the authorisation of the veterinary medicinal products mentioned in articles R. 5141-16 and R. 5141-18 are considered to include all the data necessary and sufficie…
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