The legal foundation of the production and use of herd-specific vaccines in Europe.

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.