Scientific Opinion Paper

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Auflistung Scientific Opinion Paper nach Themengebiet "Gesundheit"

Gerade angezeigt 1 - 3 von 3
  • Vorschaubild
    Veröffentlichung
    Improving environmental protection in EU pharmaceutical legislation
    (Umweltbundesamt, 2022) Gildemeister, Daniela; Buck, Annika; Hein, Arne; Rönnefahrt, Ines; Ebert, Ina; Debiak, Malgorzata
    In preparation of the revision of Directive 2001/83/ EC and Regulation (EC) No 726/2004, the German Environment Agency (UBA) proposes legal changes to reduce pharmaceutical residues in the environment. The proposals are based on UBA's experiences as competent authority for the environmental risk assessment (ERA) of pharmaceuticals. Our overall aim is to ensure a comprehensive risk management system without compromising availability of medicines for patients. In this context we consider the recent EU strategy on pharmaceuticals and initiatives in connection with EU`s Green Deal particularly the Zero Pollution Ambition and the one substance one assessment approach. Quelle: www.umweltbundesamt.de
  • Vorschaubild
    Veröffentlichung
    Monographs of Environmental Data for Active Substances in Veterinary Pharmaceuticals
    (Umweltbundesamt, 2023) Rönnefahrt, Ines; Schmitz, Susanne; Ebert, Ina; Deutschland. Umweltbundesamt
    This scientific opinion paper outlines existing problems related to data gaps, non-harmonized assessments, insufficient post-market control, and data transparency of pharmaceuticals, and identifies possible solutions through the introduction of a monograph system for active pharmaceutical substances. From UBA's point of view, monographs are the crucial bridge between risk assessment, risk communication and risk management and this across different regulatory areas. The current revision of the general pharmaceutical legislation of the EU offers the opportunity to establish a monograph system for active substances for both veterinary medicinal products and medicinal products for human use. Quelle: www.umweltbundesamt.de
  • Vorschaubild
    Veröffentlichung
    The Zero Pollution Action Plan as a chance for a cross-regulatory approach to pollution prevention and reduction
    (Umweltbundesamt, 2021) Conrad, André; Hildebrandt, Sophia; Klauk, Anja; Langner, Marcel; Schubert, Tim; Schulte, Christoph; Schwan, Johannes; Suhr, Michael; Tietjen, Lars; Vierke, Lena; Deutschland. Umweltbundesamt
    To further prevent and reduce the pollution of air, water, and soil and to safeguard human health and well-being, the European regulatory framework needs to be improved to include a cross-regulatory approach. This scientific opinion paper presents such an approach for the systemic protection of air, water, soil and human health- the Zero Pollution Ambition Cycle developed by the German Environment Agency (UBA)- The implementation of the measures announced by the European Commission within the EU Action Plan 'Towards Zero Pollution for Air, Water and Soil' published in May 2021 is an excellent opportunity for the different stakeholders for further developing and applying this integrated approach. Source: www.umweltbundesamt.de