Regulatory review of the environmental risk assessment of veterinary medicinal products in the European Union, with particular focus on the centralised authorisation procedure
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DOI: 10.1186/s12302-020-00374-x
Abstract: In the EU, the requirement for a two-tier-based environmental risk assessment for a veterinary medicinal product applies for marketing authorisations submitted since 1993. This article outlines the framework for conducting environmental risk assessments and provides… read more here.
Keywords: risk; environmental risk; risk assessment; assessment veterinary ... See more keywords
[Vigilance for veterinary medicinal products: Reports of adverse reactions in the year 2016].
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DOI: 10.17236/sat00132
Abstract: INTRODUCTION A total of 253 reports of adverse reactions to veterinary medicinal products were received during the year 2016 representing a decrease of 13% compared to the previous year (292 reports). The majority of the… read more here.
Keywords: medicinal products; year; reports adverse; adverse reactions ... See more keywords
Development of a Database for Study Data in Registration Applications for Veterinary Medicinal Products
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DOI: 10.18849/ve.v2i1.49
Abstract: Objective: In the present study, the feasibility of a systematic record of clinical study data from marketing authorisation applications for veterinary medicinal products (VMP) and benefits of the selected approach were investigated. Background: Drug registration… read more here.
Keywords: study data; medicinal products; study; veterinary medicinal ... See more keywords
International regulatory considerations pertaining to the development of stem cell-based veterinary medicinal products
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DOI: 10.4142/jvs.2021.22.e6
Abstract: Stem cell-based products (SCPs) are an emerging field of veterinary medicine that focuses on the regeneration, repair, or replacement of damaged tissues or organs. However, there are some issues in applying the traditional regulatory guideline… read more here.
Keywords: cell based; stem cell; medicinal products; veterinary medicinal ... See more keywords