This source outlines the Good Manufacturing Practice (GMP) guidelines for the production of biological active substances and medicinal products for human and veterinary use within the European Union. It provides guidance supplementary to existing GMP rules, focusing on the specific complexities of manufacturing biologicals, such as controlling inherent variability, preventing contamination, and ensuring traceability, particularly concerning materials derived from human and animal sources. The document is organized into general guidance covering personnel, premises, equipment, animals, documentation, production, and quality control, and specific guidance for selected product types including animal-sourced products, vaccines, and recombinant products. This comprehensive annex helps ensure the quality, safety, and efficacy of biological medicinal products.