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GUIDANCE DOCUMENT

CVM GFI #117 (VICH GL24) Management of Adverse Event Reports (AER's) May 2006

Draft

Not for implementation. Contains non-binding recommendations.

Docket Number:
FDA-2000-D-0136
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

Pharmacovigilance of veterinary medicinal products (VMPs) can be defined as the detection and investigation of the effects of the use of these products, mainly aimed at safety and efficacy in animals and safety in people exposed to the products. This document will only deal with the spontaneous reporting system for identification of possible adverse events following the use of marketed VMPs.

Within all regions involved in the VICH process there are certain legal obligations for the pharmaceutical industry, the commercial party responsible for the products, with regard to adverse events reported to them. Those legal obligations relate to the acceptance of adverse event reports and the storage and submission of those reports to the authorities.

It is of importance for all parties, the Marketing Authorization Holders (MAHs), the Regulatory Authorities (RA) and the users of VMPs to develop harmonized and common systems, common definitions and standardized terminology within pharmacovigilance. Harmonization of those elements between the regions facilitates the reporting responsibilities for the MAHs, many with worldwide activities. At the same time harmonization of systems and requirements facilitates the inter-regional comparison of data and exchange of information, thereby increasing the general knowledge of a product`s general performance and safety profile.


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-2000-D-0136.

Questions?

Contact Point
Linda Walter-Grimm
Center for Veterinary Medicine
Office of Surveillance and Compliance
Food and Drug Administration
7519 Standish Place, HFV-241
Rockville, MD 20855