This Regulation lays down the measures on good distribution practice for active substances used as starting materials in veterinary medicinal products. This Regulation shall apply to importers and distributors of active substances used as starting materials in veterinary medicinal products, and to manufacturers who distribute active substances, which they manufactured, used as starting materials in veterinary medicinal products. More specifically, this Regulation sets out requirements for the development and maintenance of a quality system and for premises and equipment, and the responsibilities of all personnel involved in the distribution of active substances used as starting materials in veterinary medicinal products.
2021-08-02