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Showing 6101–6110 of 24245 articles for “Art. 1843-4”
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…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may also suspend, for a period not exceeding one year, or revoke a marketing auth…
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…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may automatically vary a marketing authorisation for a veterinary medicinal produ…
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 experimenters, investigators, experts and persons called upon to collaborate in the trials are bound by professional secrecy under the conditions and penalties laid down inarticle 226-13 of the Fr…
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…
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