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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Georg Thieme Verlag KG
2022
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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 |
collection | PubMed |
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. |
format | Online Article Text |
id | pubmed-9546638 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Georg Thieme Verlag KG |
record_format | MEDLINE/PubMed |
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 |