This Decision establishes unified rules for regulating veterinary diagnostic products within the customs territory of the Eurasian Economic Union (EAEU). It defines the rights and obligations of manufacturers, registration holders, authorized representatives, and competent authorities, and sets common requirements for the circulation of veterinary diagnostic tools that do not directly interact with animals. The objective is to harmonize regulatory approaches across EAEU member states, ensure product quality and safety, and prevent the circulation of falsified, counterfeit, or substandard diagnostic products. The rules introduce a comprehensive registration and conformity assessment framework. Veterinary diagnostic products may circulate in the EAEU only if they are registered under the established procedures and manufactured at compliant facilities. Applicants must submit a technical dossier containing detailed information on the product, its composition, manufacturing process, quality controls, and intended use. Registration decisions are based on expert evaluation, laboratory testing, and inspection results. The document also sets requirements for manufacturing, storage, transportation, documentation, personnel qualifications, and post-registration monitoring. In addition, the regulation establishes common EAEU information systems and registers for veterinary diagnostic products, manufacturers, and regulatory decisions, facilitating transparency and cooperation among member states. It contains procedures for registration renewal, amendments, suspension or cancellation of registrations, market surveillance, and appeals. The rules also include detailed annexes covering technical dossier requirements, labelling standards, testing methodologies, and inspection procedures. Transitional provisions allow nationally registered products to remain valid until the end of 2028, supporting a gradual transition to the unified EAEU regulatory framework.
2022-09-23