Article R5133-4
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…
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Showing 8991–9000 of 54180 articles for “Art. II-4°”
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…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may also suspend, for a period not exceeding one year, or revoke a marketing auth…
Decisions to grant, automatically vary, refuse, renew or revoke marketing authorisations subject to the national procedure are taken in accordance with the procedures laid down in Article R. 5141-27 r…
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…
The Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may automatically vary a marketing authorisation for a veterinary medicinal produ…
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…
The experimenters, investigators, experts and persons called upon to collaborate in the trials are bound by professional secrecy under the conditions and penalties laid down inarticle 226-13 of the Fr…
In an emergency, the Director General of the Agence nationale de sécurité sanitaire de l'alimentation, de l'environnement et du travail may suspend, for a maximum period of three months, the dissemina…
Placing on the market, whether free of charge or for a consideration, a tattoo product whose container or packaging does not bear one of the indications provided for in article R. 513-10-5 is punishab…
Repeated offences under articles R. 5438-1 and R. 5438-2 are punishable in accordance with articles 132-11 and 132-15 of the French Criminal Code.
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