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Showing 4041–4050 of 52210 articles for “Art. al. 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…
…type of toxin and for one or more of the operations mentioned in the first paragraph of Article R. 5139-1 carried out within a specific establishment. Authorisation may not be issued to a legal entity…
…e de sécurité du médicament et des produits de santé under the conditions mentioned in Articles R. 5139-3 to R. 5139-7 . Failure to submit a new application for authorisation will result in the immedi…
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.
…isition 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 subject to an authorisation issued by the Director General of…
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…
…nce with 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°…
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…
…active substance or substances do not yet appear, for the species or species in question, in Table 1 of the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically act…
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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