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Showing 6791–6800 of 47092 articles for “Art. L. 311-4”
The application for authorisation shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by registered letter with acknowledgement of receipt…
Manufacturers, importers and distributors of reagents, as well as users, and in particular medical biology analysis laboratories, shall transmit to the Agence nationale de sécurité du médicament et de…
Decisions to grant, automatically vary, refuse, renew or revoke marketing authorisations subject to the national procedure are taken in accordance with the procedures laid down in Article R. 5141-27 r…
The decision to suspend, revoke or vary the marketing authorisation must state the reasons on which it is based and indicate the appeal procedures and deadlines. Except in cases of urgency, the decisi…
Independently of decisions to suspend, modify or withdraw authorisations and as a precautionary measure, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'envi…
The procedures for submitting and examining applications for authorisation to open, for modification of initial authorisations and for transfer of authorisations to open, as provided for in articles R…
For the purposes of calculating the number of staff referred to in articles R. 5142-38 and R. 5142-39, account is taken of persons engaged in the following operations: 1° Manufacturing and import oper…
A veterinary pharmaceutical establishment which manufactures medicinal products mentioned in 1° of article R. 5142-1 has a documentation system comprising specifications, manufacturing formulae, proce…
When a pharmacist or assistant veterinarian recruited in application of article R. 5142-37 is absent or replaces the pharmacist or veterinarian in charge for a period of more than one month, he is rep…
The establishments referred to in article R. 5142-1 shall take all necessary measures to ensure that veterinary medicinal products are transported and delivered under conditions which guarantee their…
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