Article R5221-34
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…
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Showing 9261–9270 of 51804 articles for “Art. L 225-3”
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.
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…
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…
Presenting medical devices that do not comply with the provisions of articles R. 5211-12 and R. 5211-17 at scientific or technical meetings, exhibitions or demonstrations without displaying a sign cle…
Repeated offences under articles R. 5431-1 and R. 5431-2 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.
Repeated offences under article R. 5437-1 are punishable in accordance with articles 132-11 and 132-15 of the French Penal Code.
The information contained in each advertisement shall be accurate, up-to-date, verifiable and sufficiently complete to enable, as appropriate, the general public to understand the intended use of the…
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