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GUIDANCE DOCUMENT

CVM GFI #214 (VICH GL35) Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data December 2014

Final
Docket Number:
FDA-2011-D-0588
Issued by:
Guidance Issuing Office
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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-D-0588.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002