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Showing 9831–9840 of 33489 articles for “Art. 815-3”
When the pharmacist or veterinary surgeon responsible for an establishment engaged in the manufacture, import or use of veterinary medicinal products, other than those subject to clinical trials, beco…
Assistant pharmacists or veterinary surgeons entrusted with the release of batches must have at least six months' professional experience under the conditions set out in article R. 5142-16 before taki…
The manufacturer is required to update the risk analysis and management system referred to in Article R. 5211-23-2 by analysing all elements relating to the medical devices he manufactures and taking…
The bodies responsible for implementing the assessment procedures provided for in this Title shall be authorised for this purpose by a decision of the Director General of the Agence nationale de sécur…
The certificate is issued by the person responsible for transferring the second-hand medical device to the transferee.
The resale of a second-hand medical device is understood to mean any transfer of a medical device which is neither new nor refurbished within the meaning of 2° of article R. 5211-4. The second-hand re…
The certificate drawn up by the person responsible for the second-hand resale certifies that the second-hand in vitro diagnostic medical device has been serviced as part of the accreditation referred…
By way of derogation from the provisions of article R. 5212-35-4, where the second-hand medical device being transferred has never been put into service, the file is composed solely of the following e…
The Agence nationale de sécurité du médicament et des produits de santé (French National Agency for the Safety of Medicines and Health Products) carries out inspections on file or on site at least onc…
In all cases where the Agency's inspectors identify an infringement likely to result in criminal proceedings, the Agency's Director General will forward the report(s) referred to in Article L. 5411-2…
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