Zdrowie i gospodarka · 21/04/2004
International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Draft Guidance for Industry on Environmental Impact Assessments for Veterinary Medicinal Products-Phase II; Request for Comments; Availability
The Food and Drug Administration (FDA) is announcing the availability for comments of a draft guidance document for industry ([numsign]166) entitled "Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)--Phase II" (VICH GL38). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document provides recommendations for internationally harmonized test methods used to generate environmental fate and toxicity data.