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Showing 10771–10780 of 36632 articles for “Art. al. 5”
In the case of blood-derived medicinal products, the Agence nationale de sécurité du médicament et des produits de santé may, when examining the application for marketing authorisation, submit samples…
By way of derogation from 2° of Article R. 5121-25, for the medicinal products mentioned in this article, the dossier attached to the marketing authorisation application is compiled under the followin…
…The prescriber's request for compassionate access authorisation as provided for in II of Article L. 5121-12-1 is sent to the Agence nationale de sécurité du médicament et des produits de santé by elec…
…security and, for applications relating to a medicinal product mentioned in 1° of II of Article L. 5121-12, to the Agence nationale de sécurité du médicament et des produits de santé, with the except…
In order to obtain recognition in France of a marketing authorisation issued by another State, known as the reference State, which is a member of the European Community or a party to the Agreement on…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé or the applicant for marketing authorisation may refer the matter to the European Medicines Agency with…
…f the benefit/risk balance of the medicinal product as defined in the first paragraph of article L. 5121-9, as assessed by the Director General of the Agency, is no longer favourable. If no decision i…
The specific obligations which may be imposed pursuant to the third paragraph of Article L. 5121-9 and which must be mentioned in the risk management system are, in particular, the following: 1° The a…
The Director General of the Agence nationale de sécurité du médicament et des produits de santé may require samples and mock-ups to be submitted when the medicinal product is marketed.
…ring of the risk, its complications and its medico-social management, as provided for in Article L. 5121-8-1. The Director General of the Agency may request that these studies or this specific monitor…
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