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Showing 10761–10770 of 36632 articles for “Art. al. 5”
In order to obtain a marketing authorisation for a medicinal product which is not covered by the marketing authorisation procedure issued by the European Commission pursuant to Regulation (EC) No 726/…
…istics, the package leaflet, any conditions set in application of the third paragraph of article L. 5121-9, article R. 5121-36-1 and article R. 5121-37-3, together with their implementation period ; 1…
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…
…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…
…santé an application for authorisation to market the genetically modified organism underArticle L. 533-5 of the Environment Code. The provisions of article R. 533-49 of the same code are applicable t…
…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…
In order to be able to continuously assess the criteria mentioned in I of Article L. 5121-12, the Haute Autorité de santé and, where applicable, the Agence nationale de sécurité du médicament et des p…
…the first working day following its decision. However, when the conditions laid down in article R. 5121-157 for the implementation of the European Union emergency pharmacovigilance procedure are met,…
Each year, the Director General of the Agence nationale de sécurité du médicament et des produits de santé sends the coordination group referred to in Article 27 of Directive 2001/83/EC of the Europea…
…nce as the reference State, the application is examined under the conditions set out in Articles R. 5121-34 and R. 5121-35. The Director General of the Agency sends the States concerned and the applic…
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