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Showing 3081–3090 of 43105 articles for “Art. R. 211-4”
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…
…n or oral comment without the joint agreement of the investigator or the investigator and the sponsor.
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…
…ese examinations and tests are carried out is agreed between the authorized body and the manufacturer. Where the type meets the essential requirements, the authorised body issues the applicant with an…
…heck the manufacturing processes. The decision of the authorised body is notified to the manufacturer. It contains the conclusions of the inspection and a reasoned assessment.In all cases, the approve…
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