Zdrowie i gospodarka · 23/11/2007

International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revision); Availability

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry ( 93) entitled "Impurities in New Veterinary Medicinal Products (Revision)" VICH GL11(R). This revised guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revised document is intended to assist in developing registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States. The revised guidance addresses only those impurities in new veterinary medicinal drug products classified as degradation products.