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Showing 2711–2720 of 8285 articles for “Art. 9 juill. 2003”
Any substantial amendment to the trial must be the subject of a prior additional declaration by the sponsor sent by registered post with acknowledgement of receipt to the Director General of the Agenc…
The prior authorisation referred to in the second paragraph of article L. 5142-2 is required for the following substantial changes:-carrying out a new pharmaceutical activity within the meaning of art…
For the purposes of this Title, accessories to medical devices are treated as devices in their own right. Accessories are classified as such, independently of the devices with which they are used, wit…
If one or more of the bodies mentioned in article D. 5143-8, consulted with a view to setting up the Commission, have not formulated a proposal within one month of receiving the request from the Regio…
The financial penalties and daily fines provided for in Article L. 5145-5 are recovered by the accounting officer of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et…
In vitro diagnostic medical devices appearing on the list established by the order referred to in Article R. 5221-6, designed and manufactured in accordance with common technical specifications publis…
Any project to modify the elements mentioned in 1° and 2° of article R. 5213-5 is the subject of a new authorisation application submitted and examined under the same conditions as the initial authori…
The Chairman sets the agenda on a proposal from the Chief Executive. Items which the Minister for Health, the Chairman of the Board of Directors or at least one third of its members request to be incl…
Service providers and equipment distributors update their professional knowledge and keep abreast of developments in best practice, legislation and regulations.
Any project to modify the elements mentioned in 1° and 2° of article R. 5223-5 is the subject of a new application for authorisation submitted and examined under the same conditions as the initial app…
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