Regulation of the Minister of Agriculture no. 16 of 2021 concerning on-site review and supervision of animal drugs.

This Ministerial Regulation, implementing provisions of articles 193, 206 paragraph(3), and 222 of the Government Regulation no. 26 of 2021 on the implementation of the agricultural sector, and provisions of article 362 of the Government Regulation no. 5 of 2021 concerning implementation of risk-based business licensing, concerns on-field studies on veterinary medicine and animal drugs supply and distribution control. This Regulation defines the following relevant terms: veterinary medicine; production and distribution of veterinary medicine; business licensing; importing animal medicines; good practices and manufacturing methods for veterinary medicines; on-field studies; hormones; antibiotics; animal feed; therapeutic feed; veterinary drugs supervisor; feed quality inspectors. Matters covered by this Regulation include: certification of good manufacturing practices, and other requirements concerning field studies for importation and distribution of veterinary medicines; analysis of the results of the implementation of the field studies; issuance of importation permit; routine and incidental supervision and control on drugs and veterinary activity; quality testing on veterinary medicines; control on production and use of antibiotics for therapy; supervision of veterinary medicine business licensing; imposition of administrative sanctions; monitoring the use of certain hormones and antibiotics for therapy and animal reproduction; controls on feed mixed with antibiotics.