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The new pharmaceutical regulations for veterinary medicinal products introduced in the course of the EU harmonization also have an impact on pharmacotherapy of honey bee colonies in Germany. In particular, the requirement to use veterinary medicinal products in accordance with the terms of the marke...

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Autor principal: Emmerich, Ilka Ute
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Georg Thieme Verlag KG 2022
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9546638/
https://www.ncbi.nlm.nih.gov/pubmed/36067761
http://dx.doi.org/10.1055/a-1871-8971
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author Emmerich, Ilka Ute
author_facet Emmerich, Ilka Ute
author_sort Emmerich, Ilka Ute
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description The new pharmaceutical regulations for veterinary medicinal products introduced in the course of the EU harmonization also have an impact on pharmacotherapy of honey bee colonies in Germany. In particular, the requirement to use veterinary medicinal products in accordance with the terms of the marketing authorization not only restricts the veterinarians’ freedom of therapy, but also marks the end of off-label use of approved varroacides in honey bees not subject to pharmacy requirements by beekeepers. A deviation from the terms of the marketing authorization is only possible in the case of a so-called therapeutic emergency in the reclassification, irrespective of the sales demarcation/limitation. If such a situation exists, however, veterinary medicinal products for honey bees from other member states of the European Union may already be used in the first reclassification level, even if veterinary medicinal products with the same active ingredient are available in Germany. For this reason, the article discusses not only the impact of the required adherence to the marketing authorization, but also additional treatment options for honey bees in consequence to the harmonisation of the internal market.
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spelling pubmed-95466382022-10-08 Emmerich, Ilka Ute Tierarztl Prax Ausg G Grosstiere Nutztiere The new pharmaceutical regulations for veterinary medicinal products introduced in the course of the EU harmonization also have an impact on pharmacotherapy of honey bee colonies in Germany. In particular, the requirement to use veterinary medicinal products in accordance with the terms of the marketing authorization not only restricts the veterinarians’ freedom of therapy, but also marks the end of off-label use of approved varroacides in honey bees not subject to pharmacy requirements by beekeepers. A deviation from the terms of the marketing authorization is only possible in the case of a so-called therapeutic emergency in the reclassification, irrespective of the sales demarcation/limitation. If such a situation exists, however, veterinary medicinal products for honey bees from other member states of the European Union may already be used in the first reclassification level, even if veterinary medicinal products with the same active ingredient are available in Germany. For this reason, the article discusses not only the impact of the required adherence to the marketing authorization, but also additional treatment options for honey bees in consequence to the harmonisation of the internal market. Georg Thieme Verlag KG 2022-09-06 /pmc/articles/PMC9546638/ /pubmed/36067761 http://dx.doi.org/10.1055/a-1871-8971 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/) https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited.
spellingShingle Emmerich, Ilka Ute
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9546638/
https://www.ncbi.nlm.nih.gov/pubmed/36067761
http://dx.doi.org/10.1055/a-1871-8971