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Showing 8291–8300 of 18177 articles for “Art. 5 oct. 2017”
Cases are heard in open court. However, the Chairman may, on his own initiative or at the request of one of the parties, after having obtained the opinion of the rapporteur where appropriate, prohibit…
…ot exceeding one year, or withdraw a marketing authorisation on the grounds mentioned in Article L. 5121-9. However, where the authorisation is suspended, either as a precautionary measure pending the…
…benefit balance of the medicinal product or product as defined in the first paragraph of Article L. 5121-9. It shall forward the results of all studies, in particular safety and efficacy studies, and…
…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…
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.
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…
…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…
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 order that companies exploiting certain immunological medicinal products mentioned in article L. 5121-1 submit to the National Agency for the Safety of Medicines and Health Products a copy of all c…
…by it; 4° Appoint rapporteurs to ensure that applications comply with the provisions of this Code; 5° Requiring the applicant to complete its dossier, in particular with regard to reports on analytic…
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