Ministerial Ordinance on Standards for Non-Clinical Studies Concerning Safety of Veterinary Medicinal Products No. 74, 1997.

This Ministerial Ordinance on Standards for Non-Clinical Studies Concerning Safety of Veterinary Medicinal Products is established in accordance with the provisions in the Law on Securing Quality, Efficacy and Safety of Products including Pharmaceuticals and Medical Devices, Article 83, Paragraph 1. It establishes items relating to non-clinical tests (limited to those that are performed using test systems in test facilities for collecting and preparing data relating to acute toxicity, sub-acute toxicity, chronic toxicity, teratogenicity, as well as other toxicity, and residual effects (referring to properties that cause substances (including those substances that were formed through chemical changes) which are components of veterinary medicinal products to remain in the animals (including items produced such as milk and eggs) following the use of those products), from among the data prescribed in Regulations for Veterinary Medicinal Products (2004 Ordinance of the Ministry of Agriculture, Forestry and Fisheries No. 107.