Zdrowie i gospodarka · 02/05/2006
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products; Data Elements for Submission of Adverse Event Reports (VICH GL42); Request for Comments; Availability
The Food and Drug Administration (FDA) is announcing the availability for comments of a draft guidance document for industry ( 182) entitled "Pharmacovigilance of Veterinary Medicinal Products; Data Elements for Submission of Adverse Event Reports" (VICH GL42). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The objective of this draft guidance document is to standardize the data for submission of adverse events relating to veterinary medicinal products.