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Showing 2641–2650 of 42843 articles for “Art. R 134-4”
The procedures for applying sections 1 to 3 of this chapter to the establishments mentioned in articles L. 5126-1 and L. 5126-11 shall be laid down, where appropriate, after obtaining the opinion of t…
The order for professional use of medicinal products intended for human medicine mentioned in this section must indicate legibly : 1° The name, title, registration number, address and signature of the…
Preparations containing either one or more substances included in lists I and II defined in article L. 5132-6, or one or more narcotic or psychotropic substances, in doses or concentrations too low to…
The application for authorisation shall be sent to the Director General of the Agence nationale de sécurité du médicament et des produits de santé by registered letter with acknowledgement of receipt…
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 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…
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…
Each batch of veterinary medicinal products benefiting from a marketing authorisation referred to in article L. 5141-5 or a registration referred to in article L. 5141-9 is subject to control of the f…
Veterinary pharmaceutical establishments operate in accordance with the good practices mentioned in article L. 5142-3 which are applicable to them. In particular, they have : 1° Premises fitted out, a…
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