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Showing 6721–6730 of 26171 articles for “Art. 4 B”
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…
…roduct where it appears, in particular following evaluation of the data referred to in article R. 5141-90, that the medicinal product no longer meets the conditions referred to in article L. 5141-6. I…
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…
…cision 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 decision may…
…en it appears : 1° Either, in particular following evaluation of the data mentioned in article R. 5141-90, that the medicinal product no longer satisfies the conditions mentioned in article L. 5141-6;…
…Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may prohibit the supply of certain batches of authorised veterinary medicinal products that are the subject o…
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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