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Showing 2741–2750 of 8477 articles for “Art. 9 déc. 2009”
Exceptionally and where necessary, in order to ensure the availability of medicinal products, where a manufacturing establishment of an active substance intended for export and located in a third coun…
Apart from cases of transit through or through customs territory, it is prohibited to import or export psychotropic drugs without a special authorisation issued for each operation by the Director Gene…
Persons engaged in national and international trade are required to draw up an annual summary statement indicating for each psychotropic substance or medicinal product containing it: 1° The quantities…
…ts containing one or more psychotropic substances are subject to the provisions of articles R. 5132-91 to R. 5132-94.
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…
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