Institute of Pharmacology and Toxicology, Department for Biomedical Sciences, University of Veterinary Medicine Vienna, Veterinärplatz 1, A-1210 Vienna, Austria.
Vaccine. 2013 Aug 12;31(36):3651-5. doi: 10.1016/j.vaccine.2013.05.099. Epub 2013 Jun 10.
In veterinary medicine, herd-specific vaccines are primarily used in farm animals if traditional vaccines are either unavailable or do not perform as expected. As autogenous products, these vaccines are exempt from Directive 2001/82/EC, and therefore the production and use of herd-specific vaccines are regulated differently in each member state of the European Union (EU). This study is an overview of the diverse legal statuses of herd-specific vaccines among European countries. The study was conducted by analyzing legal documents, tailored questionnaires answered by subject-related authorities from sixteen European countries, and related literature. These analyses revealed that tremendous heterogeneity exists with respect to the legal requirements for the production and use of herd-specific vaccines among the countries that were examined. In particular, certain countries have detailed and precise regulations for these vaccines, whereas the legislation regarding these vaccines is vague or even nonexistent in other nations. The implementation of standardized definitions, guidelines for vaccine use in the field, and regulations for vaccine production are essential prerequisites for achieving legal consistency across Europe. These measures would also help countries enact pertinent national legislation with less divergence regarding the production and use of herd-specific vaccines and ensure the existence of comparable safety and quality standards for these vaccines among European countries.
在兽医领域，如果传统疫苗无法获得或效果不理想，通常会在农场动物中使用针对特定畜群的疫苗。由于这些疫苗属于同源产品，因此不受 2001/82/EC 指令的约束，因此在欧盟的每个成员国中，针对特定畜群的疫苗的生产和使用的监管方式都有所不同。本研究对欧洲各国针对特定畜群的疫苗的不同法律地位进行了概述。通过分析法律文件、针对来自 16 个欧洲国家的与主题相关的主管部门的定制调查问卷以及相关文献，开展了这项研究。这些分析表明，在所研究的国家中，针对特定畜群的疫苗的生产和使用的法律要求存在巨大差异。具体而言，某些国家对这些疫苗有详细和精确的规定，而其他国家的相关立法则较为模糊，甚至不存在。制定标准化定义、针对现场疫苗使用的指南以及疫苗生产法规是实现全欧洲法律一致性的必要前提。这些措施还有助于各国制定相关的国家立法，减少针对特定畜群的疫苗生产和使用方面的分歧，并确保在欧洲各国之间为这些疫苗建立可比的安全和质量标准。
