| Author (Corporate) | European Commission |
|---|---|
| Series Title | COM |
| Series Details | (2016) 223 final (21.4.16) |
| Publication Date | 21/04/2016 |
| Content Type | Policy-making, Report |
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Article 26 of Directive 2004/23/EC requires Member States to submit to the European Commission, before 7 April 2009 and every three years thereafter, a report on the activities carried out in relation to the provisions of the Directive, including an account of the measures taken in relation to inspection and control. The Commission is required to transmit these national reports to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. The Commission is also required to provide the European Parliament and the Council with an overview report on the implementation of the requirements of the Directive, in particular as regards inspections and monitoring. In addition, Member States also have to submit to the Commission reports on the application of the principle of voluntary and unpaid donation (VUD) every three years. On the basis of these national reports, the Commission is required to report to the European Parliament and the Council and to inform them of any necessary further measures in relation to VUD it intends to take at Union level. This report is based on the replies to questionnaires that the Commission sent to Member States in 2012 (verification of the completeness of transposition), 2013 (implementation survey), and 2014 (implementation of the VUD principle) and follows up on the Commission communication published in January 2010 as well as the two reports on the application of the principle of VUD for tissues and cells issued in 2006 and 2011. All Member States replied to the transposition questionnaire. The implementation survey was answered by all Member States except Greece, and also by two EEA countries, Liechtenstein and Norway. All Member States, and also Liechtenstein and Norway provided answers to the survey on the implementation of the VUD principle. The full analysis of the Member States’ replies to the 2013 implementation survey and the 2014 survey on the implementation of the VUD principle is included in the two staff working documents accompanying this report. Besides complying with the legal obligations, the current report sets out how Directive 2004/23/EC and its implementing Directives 2006/17/EC and 2006/86/EC (hereafter commonly referred to as the EU tissue and cell legislation) function in practice, against a backdrop of significant scientific and organisational developments (internationalisation, commercialisation) that have taken place in the tissue and cell sector over the past decade. Where appropriate data gathered through other channels and supporting the findings of the two surveys (e.g. exchanges with the national competent authorities during the bi-annual meetings with the Commission, mandatory annual reporting to the Commission of serious adverse reactions and events (SARE), alerts launched in the Rapid Alerts for Tissues and Cells (RATC) platform, Eurobarometer survey exploring the views of EU citizens on tissue and cell donation and the output of a number of relevant EU-funded projects and studies) were also taken into account. |
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| Source Link | http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2016:223:FIN |
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| Subject Categories | Health |
| Countries / Regions | Europe |
