GMO Liability: Options for Insurers
In: Economic Loss Caused by Genetically Modified Organisms; Tort and Insurance Law, S. 577-581
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In: Economic Loss Caused by Genetically Modified Organisms; Tort and Insurance Law, S. 577-581
In: The Geneva papers on risk and insurance - issues and practice, Band 48, Heft 3, S. 549-551
ISSN: 1468-0440
In: Scientific opinion paper April 2023
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.
In: European Business Law Review, Band 27, Heft 1
SSRN
In: Environmental science and pollution research: ESPR, Band 23, Heft 15, S. 14791-14804
ISSN: 1614-7499
In: Scientific opinion paper October 2022
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.
In: Environmental sciences Europe: ESEU, Band 28, Heft 1
ISSN: 2190-4715