CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data
The objective of this guidance is to provide recommended standards to construct a single Adverse Event Report electronic message to transmit GL42 contents to all member regions and Product Problem Reports to FDA for veterinary medicinal products.
Guidance Issuing Office Drug Administration Docket Number Adverse Event Report Product Problem Reports Regulatory Authorities
Source: fda.gov