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Guidance for Industry 
 
Pharmacovigilance of Veterinary Medicinal Products:  
Management of Periodic Summary Update Reports 
(PSUs) 
VICH GL29 
 
 
DRAFT GUIDANCE 
 
 
 
This document is being distributed for comment purposes only 
 
 
 
This draft guidance is intended to describe the reporting system for identification of possible 
adverse events following the use of marketed veterinary medicinal products (VMPs).  
 
Comments and suggestions regarding this document should be submitted to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 
20852. Submit electronic comments to http://www.regulations.gov.  All comments should be identified 
with the Docket No. 01D-0501.  
 
For further information regarding this document, contact Margarita Brown, Center for Veterinary 
Medicine, (HFV-240), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-
276-9048, e-mail: margarita.brown@fda.hhs.gov. 
.  
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
December 6, 2001 
   
Contains Non-Binding Recommendations 
DraftNot for Implementation 
 
VICH GL29 (PHARMACOVIGILANCE: PSU) 
June 2001 
For consultation at Step 4 - Draft 1 
 
 
 
 
 
P  
HARMACOVIGILANCE OF
V M P :  
  ETERINARY  EDICINAL  RODUCTS   
M P  
ANAGEMENT OF  ERIODIC 
S U R (PSU ) 
UMMARY  PDATE  EPORTS  S
 
 
 
 
Recommended for Consultation 
at Step 4 of the VICH Process 
on 28 June 2001 
by the VICH Steering Committee 
 
 
 
THIS GUIDANCE HAS BEEN DEVELOPED BY THE APPROPRIATE VICH EXPERT WORKING GROUP AND IS 
SUBJECT TO CONSULTATION BY THE PARTIES, IN ACCORDANCE WITH THE VICH PROCESS. AT STEP 7 OF 
THE PROCESS THE FINAL DRAFT WILL BE RECOMMENDED FOR ADOPTION TO THE REGULATORY BODIES OF 
THE EUROPEAN UNION, JAPAN AND USA. 
 
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Contains Non-Binding Recommendations 
DraftNot for Implementation 
 
 
Pharmacovigilance of Veterinary Medicinal Products:  Management of Periodic 
Summary Update Reports (PSUs) 
 
This draft guidance represents the agency's current thinking and does not create or confer any 
rights for or on any person and does not operate to bind FDA or the public. An alternative method 
may be used as long as it satisfies the requirements of applicable statutes and regulations. 
 
 
 
INTRODUCTION: 
The VICH Guidance GL24, Pharmacovigilance of Veterinary Medicinal Products: Management of 
Adverse Event Reports (AERs), defines the Periodic Summary Update (PSU). 
 
Based on this definition, using the terminologies as defined in the GL24 document, this document will 
give guidance related to the scope, timing and contents of the PSU. 
SCOPE: 
The scope of pharmacovigilance in this VICH document is defined as the management of the 
detection and investigation of the clinical effects of marketed veterinary medicinal products (VMPs) 
mainly concerned with the safety and efficacy in animals and the safety in people exposed to these 
products.  While pharmacovigilance in its broadest sense may entail a wide range of activities, this 
document deals with the spontaneous reporting system for the identification of possible adverse 
events following the use of marketed VMPs. 
DEFINITIONS: 
See VICH GL 24 (guidance may be found on the Internet from the CVM homepage at 
http://www.fda.gov/AnimalVeterinary/default.htm) 
TIMING OF REPORTING: 
Each VMP should have as an International Birth Date (IBD), the date of the first marketing 
authorization for the product granted in any country in the VICH region.  For administrative 
convenience, if desired by the Marketing Authorization Holder (MAH), the IBD can be designated as 
the last day of the same month.  The IBD should be the basis for harmonizing MAH periodic reporting 
dates.  To maximize harmonization until regional requirements are made synchronous with the IBD, 
the Regulatory Authority (RA) in each country where a subsequent registration occurs should discuss 
with the MAH on an individual product basis the implementation of harmonization of periodic 
reporting dates with the IBD.   
 
At the present time, the regions cannot agree on a mechanism to harmonize the frequency of 
Periodic Summary Update reports.  As a result, the frequency of report submission to RA is subject 
to regional regulatory requirements.   
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Contains Non-Binding Recommendations 
DraftNot for Implementation 
 
CONTENTS:  
1. Sender of the PSU and VMP identification 
1.1  Name and address of the MAH responsible for the VMP detailed in this PSU. 
1.2  Name and registration number of the VMP used in the country/region for which the PSU is 
prepared.  As the name of the same VMP may be different in the various regions, the other 
names should be mentioned as well. 
1.3  Time period covered by PSU (start date and end date). 
1.4  The PSU should contain AERs from the same VMP.  The same VMP is defined as the same 
active ingredients in the same concentrations in the same formulation originating from the same 
MAH, being responsible for pharmacovigilance of this/these VMP(s). 
2.  Individual AERs  
Within the respective time period covered, all reports of AEs occurring inside a region should be 
submitted in the form of a line listing or as an entire report depending on regional requirements.  All 
other AERs should be submitted as part of a global line listing.  The PSU reported as a line listing 
should include the following elements: 
 
2.1   AER identification number (VICH GL 24 A.4.1)  
2.2  Date of first exposure (VICH GL 24 B.2.11) 
2.3  Use according to label (VICH GL 24 B.2.14) 
2.4  Date of onset of AE  (VICH GL 24 B.3.1) 
2.5  Species (VICH GL 24 B.1.3) 
2.6  Number of animals exposed (VICH GL 24 B.1.1) 
2.7  Minimum Age (VICH GL 24 B.1.9.a)  
2.8  Maximum Age (VICH GL 24 B.1.9.b) 
2.9  Age Units (VICH GL 24 B.1.9.c) 
2.10 Number of animals affected (VICH GL 24 B.1.2) 
2.11 Died (VICH GL 24 B.3.8.4) 
2.12 Registered or Brand name (VICH GL 24 B.2.1) for each VMP associated with the AER 
2.13 Adverse clinical manifestations (VICH GL 24 B.3.5) 
2.14 MAH assessment (VICH GL 24 B.5.2) 
2.15 Type of submission (VICH GL 24 A.4.5) 
2.16 MAH Comment (free text) 
2.17 Country/region where the AE occurred (VICH GL 24 A.3.1 country of attending veterinarian) 
3.  Safety and Efficacy Citations 
A brief statement assessing the impact of the scientific articles in a bibliographic listing of published 
scientific articles that pertain to the safety or efficacy of the VMP should be included. 
4. Sales Volume 
The PSU should address the relationship of sales volume of the VMP related to the number of AERs.  
These volumes should be presented in such a form as to enable an incidence-calculation (number of 
AEs per country or region in relation to the sales volume in that country or region).  If the VMP is 
labelled for use in more than one species and the use in one species is unknown or the VMP is 
provided in a multiple use container, theoretical calculations are sometimes of value but should be 
treated as arbitrary. 
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Contains Non-Binding Recommendations 
DraftNot for Implementation 
 
5.  Approved label texts or approved VMP documentation 
The approved label text or approved product documentation of the region/country should accompany 
the PSU. 
6.  Actions taken for safety reasons 
An update should be presented if any significant RA-initiated or MAH-initiated actions have been 
taken, or are pending for safety reasons during the report period anywhere in the world.  The format 
should be a brief narrative stating the reasons for significant regulatory or MAH action, with 
documentation appended when appropriate. 
7. Narrative review of AERs and an Overall Safety Evaluation 
The PSU should include a brief narrative based on the MAH analysis of the AERs presented. This 
narrative, or separately to the PSU, should include a concise critical analysis and opinion on the 
risk/benefit profile of the VMP written by a suitably qualified expert for pharmacovigilance.  The PSU 
should include comment on any new important information on the following:  
 
a. evidence of previously unidentified toxicity or safety concerns 
b. increased frequency of known toxicity or expected AEs 
c. drug interactions 
d. overdose and its treatment 
e. AEs associated with off-label use 
f. human AEs associated with the use of the VMP 
 
The evaluation should indicate in particular whether the safety data remain in line with the cumulative 
experiences to date and the approved label texts and should specify any future action recommended 
and the reasons for those recommendations. 
 
 
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