Emmerich Ilka Ute
Institut für Pharmakologie, Pharmazie und Toxikologie, Veterinärmedizinische Fakultät der Universität Leipzig.
Tierarztl Prax Ausg G Grosstiere Nutztiere. 2022 Aug;50(4):265-278. doi: 10.1055/a-1871-8971. Epub 2022 Sep 6.
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.
欧盟协调过程中出台的兽药新法规也对德国蜂群的药物治疗产生了影响。特别是，按照上市许可条款使用兽药的要求不仅限制了兽医的治疗自由，也标志着养蜂人在不受药房要求限制的蜜蜂中使用已批准杀螨剂的非标签使用的终结。只有在重新分类中出现所谓的治疗紧急情况时，才可能偏离上市许可条款，而不论销售划分/限制如何。然而，如果存在这种情况，即使德国有相同活性成分的兽药，来自欧盟其他成员国的蜜蜂用兽药也可在首次重新分类级别使用。因此，本文不仅讨论了遵守上市许可要求的影响，还讨论了内部市场协调后蜜蜂的其他治疗选择。
