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Showing 10731–10740 of 36632 articles for “Art. al. 5”
…ament et des produits de santé.The application must include the information specified in Article R. 5121-21 and must be accompanied by a dossier comprising :1° A copy of the marketing authorisation, c…
…management system as conditions of the marketing authorisation, in accordance with 1° of Article R. 5121-36-1.
…renewal and modification of early access, summaries of the summary reports mentioned in Article R. 5121-70-1 and any annexes thereto under the conditions mentioned in the present section, and informa…
1° In the interests of patients or for any other public health reason and, where appropriate, at the request of the Minister for Health, the Director General of the Agence nationale de sécurité du méd…
When a change in the classification mentioned in 1° of Article R. 5121-36 is authorised, on the basis of preclinical and clinical studies considered to be significant during the scientific evaluation…
When a new indication is authorised by the Agence nationale de sécurité du médicament et des produits de santé, on the basis of preclinical and clinical studies considered significant during the scien…
For the application of 1° of Article R. 5121-26, where reference is made to published scientific literature, experts must justify the use of this bibliographical documentation and demonstrate that it…
…r which an application for early access authorisation has been submitted as mentioned in article R. 5121-68, the Haute Autorité de santé will inform the applicant of its reasoned decision within three…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé will arrange for the Agency's inspectors to take samples of proprietary medicinal products to ensure tha…
…horisation, to classify the medicinal product in the categories mentioned in 1° to 3° of Article R. 5121-36.
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