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Showing 4821–4830 of 58927 articles for “Art. Cass. 3e Civ. 1-6-2010 n° 09-65.482”
The Agence nationale de sécurité du médicament et des produits de santé shall transmit to the European Medicines Agency, for recording in the Community database, the certificates of good manufacturing…
Where the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail considers that the application or the accompanying dossier is incomplete, h…
After registration has been granted, the manufacturing methods and control techniques set out in the dossier provided for in Article R. 5141-64 are modified in line with scientific and technical progr…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail shall register the homeopathic veterinary medicinal products referred to in Artic…
The registration includes the registration number and the data mentioned in Article R. 5141-63 as approved by the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l…
Amendments concerning the data mentioned in the application and dossier provided for in articles R. 5141-63 and R. 5141-64 are submitted for approval to the Director General of the Agence nationale de…
Authorised bodies shall inform the Director General of the Agence nationale de sécurité du médicament et des produits de santé of all certificates issued, modified, supplemented, suspended, withdrawn…
If a system or kit does not meet the conditions set out in Article R. 5211-67, and in particular if it contains devices not bearing the CE marking or if the compatibility of the assembled devices is n…
The approved body may require the manufacturer to provide any information and to carry out any test or assessment necessary for it to carry out the verifications for which it is responsible.
Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have be…
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