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Showing 8081–8090 of 17962 articles for “Art. 5 avr. 2011”
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…
When, on the occasion of the implementation of Article 20(4) of Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004, urgent action is essential to protect human…
…lication file. When the Director General of the Agency makes use of the option granted to him under 5° of Article R. 5121-34, these time limits are suspended until the additional information required…
…he marketing authorisation lapses is counted from : 1° the date of publication of Decree No. 2008-435 of 6 May 2008 for marketing authorisations issued up to that date, with the exception of those for…
…roprietary medicinal product and withdraw it from the market on the grounds mentioned in Article L. 5121-14-2. The decision must state the reasons on which it is based and, except in an emergency, may…
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