Environmental Assessment for Human Medicines in the European Union
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CHMP Safety Working Party Environmental Risk Assessment Expert Group Per Spindler, DVM, MBA, MSc, BioLogue, University of Copenhagen, Copenhagen, Denmark Mark Montforts, PhD, National Institute of Public Health and the Environment, Bilthoven, The Netherlands Klaus Olejniczak, DVM, Federal Institute for Drugs and Medical Devices, Bonn, Germany Jan Koschorreck, Federal Environmental Agency, Berlin, Germany Jean-Marc Vidal, MD, European Medicines Agency, London, United Kingdom Anna-Karin Johansson, Medical Products Agency, Uppsala, Sweden Henry Stemplewski, Medicines and Healthcare Products Regulatory Agency, London, United Kingdom Virpi Virtanen, PhD, Finnish Environment Institute, Chemicals Division, Helsinki, Finland Ines Rönnefahrt, PhD, Federal Environmental Agency, Berlin, Germany Steen Kristensen, DVM, Danish Medicines Agency, Copenhagen, Denmark Jan-Willem van der Laan, PhD, National Institute of Public Health and the Environment, Bilthoven, The Netherlands Key Words Human pharmaceuticals; Human medicines; Environmental protection; Environmental risk assessment; Guideline; European Union Correspondence Address Per Spindler, DVM, MBA, MSc, BioLogue, University of Copenhagen, Blegdamsvej 3A, DK-2200 Copenhagen, Denmark (e-mail: [email protected]). This article does not necessarily represent the official view of relevant European authorities or institutions, and it is by no means an exhaustive account of the referenced regulatory guidelines. This article provides an overview of EU regulatory discussions and selected background information from the joint DIA/HESI/SAPS Conference on Environmental Assessment of Human Medicines held in Stockholm, Sweden, May 22–23, 2006.
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Environmental Assessment for Human Medicines in the European Union INTRODUCTION Environmental risk assessment (ERA) for human medicines came into force in the European Union in 1995. The legal basis was set out in Directive 93/39/EEC amending Art 4 (6) of Directive 65/65/EEC: “If applicable, reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and for the disposal of waste products, together with an indication of any potential risks presented by the medicinal product for the environment.” Therefore, regulators started to work on a guideline defining requirements on when and how to evaluate the potential environmental impact of new human medicines. At present, the legislation on medicinal products for human use set out in Directive 2001/83/EC, as amended. It confirms the requirement for an ERA, stating in Article 8 (3) under paragraph (ca), that an application for a new medicinal product shall be accompanied by an “evaluation of the potential environmental risks posed by the medicinal product. This impact shall be assessed and, on a case-by-case basis, specific arrangements to limit it shall be envisaged” and should also contain “reasons for any precautionary and safety measures to be taken for the storage of the medicinal product, its administration to patients and f
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