CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data January 2024

GUIDANCE DOCUMENT

• Docket Number: FDA-2011-D-0588
• Issued by: Center for Veterinary Medicine

The objective of this guidance is to provide recommended standards to construct a single Adverse Event Report (AER) electronic message to transmit GL42 contents to all member regions and Product Problem Reports (PPR) to FDA for veterinary medicinal products.

The need to transfer and disseminate information quickly, accurately and easily between Regulatory Authorities (RA) and Marketing Authorization Holders (MAH) on a worldwide scope is especially pertinent to the notification and assimilation of information for pharmacovigilance. Whereas the recommended definition of the pharmacovigilance information has been set forth within GL42, this GL35 guidance defines the recommended electronic standards for transfer of data.

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