Regulation on veterinary medical products.

This Regulation sets forth the principles and procedures of manufacture, import, export, use, packaging, labeling, presentation, transport, storage, prescriptive and non-prescriptive sales, permit, supply and control of veterinary medical products. The provisions of this Regulation shall apply to veterinary medicinal products intended to be placed on the market inter alia in the form of medicinal products, ready-made veterinary medicinal products or pre-mixes for medicated feeedingstuffs. The products to be used in edible animals shall be in compliance with the legislation regarding residue limits in foods of animal origin, except for products that are required to be used for animal health in the country when deemed appropriate by the Ministry. In case of withdrawal of a particular product, it is mandatory for the responsible company to inform the public and take the necessary measures to prevent the use of the faulty product. Recall notices must be made in writing and contain specific information. This Regulation has been drafted in line with the Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, as amended, and Commission Directive 91/412/EEC laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.