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  • Technical guide for the elaboration of monographs for immunological human medicinal products, 2008
    Technical Guide for the elaboration of monographs on vaccines and other immunological human medicinal products
  • Report - EDQM Annual Report 2007 - June 2008
    The activities of the European Directorate for the Quality of Medicines & HealthCare are described in terms of its 5 main areas of responsibility. The European Pharmacopoeia, including publication and communications activities and international relations European Pharmacopoeia Department Communications and Public Relations Provision of reference substances and preparations Preparation and dispatching of samples Biological Standardisation Programme The Procedure for Certification of Suitability The European network of Official Medicines Control Laboratories (OMCLs) Blood Transfusion Organ Transplantation
  • Resolution - Certification of suitability to the monographs of the European Pharmacopoeia (revised version) - February 2007
    RESOLUTION AP-CSP (07) 1 (adopted by the Public Health Committee (Partial Agreement) (CD-P-SP) on 21/02/2007) - The Public Health Committee (Partial Agreement) (CD-P-SP) consisting, for the purposes of the Convention on the Elaboration of a European Pharmacopoeia, of delegations appointed by the Parties to the said Convention, namely the delegations of Austria, Belgium, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, “the Former Yugoslav Republic of Macedonia”, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Montenegro, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey, United Kingdom and the European Union,
  • Rapport - EDQM Rapport annuel 2006 - juin 2007
    Comme chaque année, la publication du rapport annuel est l’occasion de nous tourner vers les 12 mois écoulés pour tirer le bilan de nos activités et réfléchir aux événements et réalisations de l’année.
  • Report - EDQM Annual Report 2006 - June 2007
    The activities of European Directorate for the Quality of Medicines are described in terms of its 3 main areas of responsibility: 1. the European Pharmacopoeia, including publication and communications activities, and international relations 1.1. European Pharmacopoeia Department 1.2. Communications and Public Relations 1.3. Provision of reference substances and preparations 1.4. Preparation and dispatching of samples 1.5. Biological Standardisation Programme 2. the procedure for Certifi cation of Suitability, 3. the European network of Official Medicines Control Laboratories (OMCLs). In 2006, pharmacopoeia authorities and licensing authorities all over the world showed growing interest in the work of the European Pharmacopoeia, Certification of Suitability and the network of Official Medicines Control Laboratories.
  • Recommendation N°2006 15 of the committee of ministers to member states on the background functions and responsibilities of a national transplant organisation
    Recommendation Rec(2006)15 of the Committee of Ministers to member states on the background, functions and responsibilities of a National Transplant Organisation (NTO) (Adopted by the Committee of Ministers on 8 November 2006 at the 979th meeting of the Ministers’ Deputies)
  • Rapport - EDQM Rapport annuel 2005 - juin 2006
    Comme chaque année, la publication du rapport annuel est l’occasion de nous tourner vers les 12 mois écoulés pour tirer le bilan de nos activités et réfléchir aux événements et réalisations de l’année.
  • Report - EDQM Annual Report 2005 - June 2006
    The activities of the European Directorate for the Quality of Medicines are described in terms of its 3 main areas of responsibility: 1. the European Pharmacopoeia, including publication and communications activities, and international relations, 2. the procedure for Certification of Suitability of monographs of the Pharmacopoeia, 3. the European network of Official Medicines Control Laboratories (OMCLs). In 2005, pharmacopoeia authorities and licensing authorities all over the world showed growing interest in the work of the European Pharmacopoeia, the Certification of Suitability, and the network of Official Medicines Control Laboratories.
  • Directive 2005/62/CE sur les normes et spécifications communautaires relatives à un système de qualité dans les établissements de transfusion sanguine
    DIRECTIVE 2005/62/CE DE LA COMMISSION du 30 septembre 2005 portant application de la directive 2002/98/CE du Parlement européen et du Conseil concernant les normes et spécifications communautaires relatives à un système de qualité dans les établissements de transfusion sanguine
  • Rapport - EDQM Rapport annuel 2004 - juin 2005
    Comme chaque année, la publication du rapport annuel est l’occasion de nous tourner vers les 12 mois écoulés pour tirer le bilan de nos activités et réfléchir aux événements et réalisations de l’année.