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Showing 6071–6080 of 24828 articles for “Art. 4 juin 2009”
…ble for social security of the number of boxes of the medicinal products mentioned in article D. 5134-1 dispensed to minors and invoiced to the health insurance funds between 1 September of the previo…
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…
…ect to the national procedure are taken in accordance with the procedures laid down in Article R. 5141-27 relating to the examination of these applications.They may only be the subject of a contentiou…
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…
…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;…
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…
…de l'environnement et du travail and the inspectors and control officers mentioned in article L. 5146-1. The trials may not be the subject of any written or oral comment without the joint agreement o…
…initial authorisations and for transfer of authorisations to open, as provided for in articles R. 5142-5 to R. 5142-7, R. 5142-9, R. 5142-10, R. 5142-13 and R. 5142-14, as well as the content of the f…
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