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Showing 8291–8300 of 33489 articles for “Art. 815-3”
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may give formal notice to any operator of a medical device subject to the quality control provided for i…
The decisions taken by the approved bodies under the procedures referred to in sub-sections 4, 5 and 6 of section 6 of this chapter are valid for five years. They may be renewed for five-year periods…
Manufacturers who place in vitro diagnostic medical devices on the French market and who do not have their registered office on the territory of a Member State of the European Union or a party to the…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé is notified of any changes to the information contained in the declaration.
Failure by the manufacturer, importer or distributor of a raw material for pharmaceutical use to communicate to the Agence nationale de sécurité du médicament et des produits de santé any changes to t…
Secondary accounting officers may be appointed by order of the ministers responsible for the budget and health, on the proposal of the agency's general manager and after consulting the accounting offi…
A manufacturer, importer or distributor who has registered a reagent is liable to a fine of the fifth class for failing to forward to the Agence nationale de sécurité du médicament et des produits de…
The information gathered in the course of the inspection mission is the subject of a report sent by the inspector in charge of the mission to the Director General of the Agency. The form and content o…
Legal entities declared criminally liable, under the conditions set out in article 121-2 of the French Penal Code, for the offences defined in article R. 5441-1 are liable, in addition to a fine in ac…
Legal entities declared to be criminally liable, under the conditions set out inarticle 121-2 of the French Penal Code, for the offences defined in article R. 5442-1 are liable, in addition to a fine…
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