1. Reason for Amendment
This guideline is being revised in accordance with relevant provisions under the Pharmaceutical Affairs Act, the Regulations on the Handling of Veterinary Medicinal Products, and the Regulations on the Evaluation of Safety and Efficacy of Veterinary Medicinal Products. The goal is to establish appropriate safety use standards for veterinary medicinal products used in food-producing animals by reviewing the correlation among dosage/administration, slaughter timing, and residue levels in the body. Furthermore, by reflecting international standards in this revision, it aims to contribute to the proper use of veterinary medicinal products and the safety management of livestock products.
2. Main Contents
A. Definition of Terms (Article 2)
- Revision of term definitions to clarify the scope of "residue testing," "withdrawal period," and "residue analytical method"
- Changes to analysis-related term definitions to align internationally with VICH guidelines
B. Test Methods (Article 3)
- Addition of language allowing details not specified in the Annex to follow international standards (VICH guidelines)
C. Residue Test Methods for Veterinary Medicinal Products, etc. (Annex)
- Addition of content related to honeybees and honey for residue testing of apicultural medicines (VICH GL56)
- Clarification of acceptance criteria and terms for analytical requirements (specificity, linearity, etc.) (VICH GL49)
- Clarification of the number of animals and sampling time points (VICH GL48)