866 resultados para Package inserts of medicines


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This special collection combines the latest publications written by our experts on Europe's investment future. In chronological order, this package follows the developments of how European investment has been dealt with, and what would be needed to make for a more ambitious plan.

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This paper anticipates the 2012 revision of the European Insolvency Regulation, which is the sole Union legislation on the subject of cross border insolvency proceedings. The paper first describes the historical background of the Regulation. The salient point of the historical discussion is that the Regulation is the product of forty years of negotiation and arises from a historical context that is no longer applicable to current economic realities, i.e. it provides for liquidation, not reorganization, it doesn’t deal with cross border groups of companies, and it lacks an effective mechanism for transparency and creditor participation. The paper then reviews the unique hybrid jurisdictional system of concurrent universal and territorial proceedings that the Regulation imposes. It looks at this scheme from a practical viewpoint, i.e. what issues arise with concurrent proceedings in two states, involving the same assets, the same creditors, and the same company. The paper then focuses on a significant issue raised by the European Court of Justice in the Eurofoods case, i.e. the need to comply with fundamental due process principles that, while not articulated in the Regulation, lie at the core of Union law. Specifically, the paper considers the ramifications of the Court’s holding that “a Member State may refuse to recognize insolvency proceedings opened in another Member State where the decision to open the proceedings was taken in flagrant breach of the fundamental right to be heard.” In response to the Court’s direction, this paper proposes a package of due process rights, consisting principally of an accessible, efficient and useful insolvency database, the infrastructure of which already exists, but the content and use of which has not yet been developed. As part of a cohesive three part due process package, the paper also proposes the formation of cross border creditors' committees and the establishment of a European Insolvency Administrator. Finally, on the institutional level, this paper proposes that the revision of the Regulation and the development of the insolvency database not only need to be coordinated, but need to be conceptualized, managed and undertaken, not as the separate efforts of diverse institutions, but as a single, unified endeavor.

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Cette recherche se propose de réfléchir sur la place des groupes d’intérêts dans le système politique de l’UE en partant de l’exemple de la filière lait. Dans un système généralement pluraliste, la PAC fait en effet figure de cas particulier puisqu’elle a fonctionné à partir des années 1960 sur une logique de co-gestion de la politique des marchés entre la Commission et la principale fédération agricole européenne, le Comité des Organisations Professionnelles agricoles (COPA) associé depuis 1962 au Comité Général de la Coopération agricole de l'Union européenne (COGECA). Néanmoins, du fait du processus de réforme de la PAC engagé depuis 1992, il paraît nécessaire d’analyser si la logique de co-gestion est remise en cause. Cette recherche conclue qu’il existe bien un rapport néo-corporatiste dans le secteur laitier, dans le sens où un acteur en particulier, le syndicat COPA-COGECA est parvenu à influencer de manière déterminante la procédure en obtenant de renforcer le pouvoir de négociation des producteurs sans revenir sur les réformes récentes de la PAC.

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On 19 May 2015, the European Commission published a very comprehensive, ambitious and innovative Better Regulation package, which contains new guidelines on various phases of the policy cycle and various documents setting out the rules and functioning of entirely new consultation platforms and a new body in charge of regulatory scrutiny. This Special Report presents some initial impressions on the content of this remarkable set of new documents, which will shape the way in which EU policies will be prepared, shaped, monitored and evaluated in the years to come.

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Back in July 2015, we acknowledged the priorities established by the Luxembourg presidency, topped by ambitious cross-sectoral dossier of Better Regulation and the Interinstitutional Agreement negociations. We investigated these issues through the lens of their “A Union for the Citizens” pledge. With four months left, this promise to EU citizens still has much to deliver if it is to meet expectations. This paper is a mid-term look at the advances made with these dossiers.

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National Highway Traffic Safety Administration, Washington, D.C.