#143 
 
Guidance for Industry 
 
Pharmacovigilance of Veterinary Medicinal Products: 
Controlled List of Terms 
 
VICH GL30 
 
Submit comments on this guidance at any time.  Submit  electronic comments on the guidance to 
http://www.regulations.gov.   Submit written comments to the Division  of Dockets Management 
(HFA-305), Food and Drug Administration,  5630 Fishers Lane, Room 1061, Rockville,  MD  
20852.  All written comments should be identified  with the Docket No.  FDA-2002-D-0268 
(formerly Docket No. 2002D-0005). 
 
For further information  regarding this document, contact the Division of Veterinary Product 
Safety (HFV-240), Office of Surveillance and Compliance, Center for Veterinary Medicine, Food 
and Drug Administration,  7519 Standish Place, Rockville, MD 20855, Email:   
CVMAESupport@fda.hhs.gov. 
 
Additional  copies of this guidance document may be requested from the Communications  Staff 
(HFV-12), Center for Veterinary Medicine, Food and Drug Administration,  7519 Standish Place, 
Rockville,  MD  20855, and may be viewed on the Internet at 
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/u
cm123602.htm  or http://www.regulations.gov 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
October 2014 
    Contains Non-Binding Recommendations 
 
VICH GL30 (PHARMACOVIGILANCE:   LIST OF TERMS) 
June 2010 
For Implementation at Step 7 
 
 
 
 
 
PHARMACOVIGILANCE OF 
VETERINARY MEDICINAL PRODUCTS: 
CONTROLLED LIST OF TERMS 
 
 
 
 
Recommended for Implementation 
at Step 7 of the VICH Process 
by the VICH Steering Committee 
in June 2010 
for implementation  by December 2015 
 
 
 
 
 
 
 
 
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 is recommended for adoption to the regulatory bodies of the European 
Union, Japan and USA. 
 
   
2  Contains Non-Binding Recommendations 
PHARMACOVIGILANCE  OF VETERINARY  MEDICINAL  PRODUCTS: 
1
Controlled Lists of Terms  
 
This guidance represents the Food and Drug Administrations (FDA or Agency) current thinking 
on this topic. It does not create or confer any rights for or on any person and does not operate to 
bind FDA or the public. You can use an alternative approach if the approach satisfies the 
requirements of the applicable statutes and regulations. If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing this guidance using the contact 
information on the title page of this guidance. 
 
 
 
I.  INTRODUCTION 
 
To assess the safety and efficacy of veterinary medicinal  products, the use of controlled lists of 
terms is important in order to assure consistency, as well as to provide for comparison between 
products and across product classes. The data fields that warrant controlled  lists of terms have 
been identified  in FDAs Guidance for Industry (GFI) #188, Data Elements for Submission  of 
Veterinary Adverse Event Reports to the Center for Veterinary Medicine [(CVM)] (FDACVM 
GFI#188) available on the FDA website at  
http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/Guidancef
orIndustry/UCM213153.pdf. 
 
Regulatory authorities (RA) and industry have partnered in the development  of the lists and of an 
appropriate maintenance procedure (through the ad-hoc Controlled  Lists of Terms 
Implementation  Task Force from June 2008 to February 2009).  The lists have been developed 
by making use of existing  lists from RA and industry. 
 
The controlled  lists of terms provide a level of discrimination  appropriate to record, search and 
categorize for trending. The lists have recommended groupings  of terms of a manageable size 
but with sufficient detail to provide for uniform input and analysis.  The controlled lists are 
accessible via the FDA website at 
http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm212682.htm.   For the 
data fields that use controlled lists of terms, user systems can, to facilitate reporting or inputting, 
use a subset of terms listed in this guidance that are considered relevant to the region and to the 
products involved.   However, when receiving reports electronically  that are compliant  with the 
relevant VICH guidances, all systems should be capable of importing  and storing the full report, 
including  all terms and codes, without loss of information. 
   
                                              
1 This title harmonizes this guidance, to the extent consistent with FDA regulations, with the International 
Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products 
(VICH) guidance document, Pharmacovigilance of Veterinary Medicinal Products Controlled Lists of Terms 
(VICH GL30), but identifies it as having some FDA-specific applications. 
 
3  Contains Non-Binding Recommendations 
FDAs guidance documents, including  this guidance, do not establish legally  enforceable 
responsibilities.  Instead, guidances describe the Agencys current thinking  on a topic and should 
be viewed only as recommendations,  unless specific regulatory or statutory requirements are 
cited. The use of the word should in Agency guidances means that something is suggested or 
recommended, but not required. 
 
II.  SCOPE 
 
This document provides guidance on the controlled  lists of terms critical to completing  the 
controlled  data fields as identified  in FDACVM GFI#188.  This document includes also an 
appropriate maintenance procedure to keep the lists of terms up to date. 
 
III.  SPECIFICATIONS 
 
III.1.  List of Terms (see Annex A) 
 
The lists should be updated in line with the maintenance procedure described in section III.2. 
 
The controlled  lists of terms as referred to in the data elements in FDACVM GFI#188 should be 
used for submission  of adverse event reports.  The lists include: 
 
a.  Reporter Categories (FDACVM GFI#188 A.3.1.1 and A.3.2.1) 
 
b.  RA Identifier Codes (FDACVM GFI#188 A.4.1) 
 
c.  Type of Submission (FDACVM GFI#188 A.4.4.1) 
 
d.  Type of Information in Report (FDACVM GFI#188 A.4.4.3) 
 
e.  Attending Veterinarians Health Status Assessment (FDACVM GFI#188 B.1.2.1) 
 
f.  Species (FDACVM GFI#188 B.1.3) 
 
The species list contains the predominant  species or general collection  of species terms 
that are being observed in adverse event reports by regulators and industry.  The list 
accommodates data entry of commonly  known terms and therefore does not follow 
taxonomy. 
 
g.  Breeds (FDACVM GFI#188 B.1.4) 
 
The breed list contains commonly  reported subspecies/breeds for the species identified  in 
the Species list but also includes the special circumstances of: 
 
  other: to provide for submission  data for breeds that have not yet been included 
(e.g., other rodent (other)). 
4  Contains Non-Binding Recommendations 
  unspecified:  to provide for identification  of breed if the general breed could be 
identified  but not the specific one (e.g., Pointing  dog  German (unspecified) if it 
was not identified  whether it was a shorthair or wire haired German pointing  dog). 
  mixed:   to provide for the submission  of cases that include a mix of different breeds 
for which it was not possible and/or not useful to identify  the specific breeds of the 
group, e.g., Mixed (cattle). 
 
h.  Gender (FDACVM GFI#188 B.1.5) 
 
i.  Reproductive Status (FDACVM GFI#188 B.1.6) 
 
j.  Female Physiological Status (FDACVM GFI#188 B.1.7) 
 
k.  Precision Categories (FDACVM GFI#188 B.1.8.1 and B.1.9.1) 
 
l.  RA Assessment (FDACVM GFI#188 B.2.1.6) 
 
m. Route of Exposure (FDACVM GFI#188 B.2.1.7) 
 
The VICH list that has been developed by the Controlled  Lists of Terms Implementation 
Task Force is a comprehensive list that includes routes of exposure specific to veterinary 
medicinal  products.  At this stage however, in an interim phase, it is agreed to use a less 
detailed list that is in operation by the FDA. 
 
This interim phase should end when the relevant International Route of Exposure list 
becomes available.  This list is being developed in the frame of ISO prEN 11239 Health 
informatics  Identification of Medicinal Products  Data elements and structures to 
uniquely identify pharmaceutical dose forms, units of presentation and routes of 
administration.  When the relevant ISO list contains the specific veterinary routes of 
exposure that are included  in the VICH Route of Exposure list, the Maintenance 
Committee (see III.2.2) should verify and decide whether to replace the interim FDA list 
with the relevant ISO list. 
 
n.  Units of Presentation (FDACVM GFI#188 B.2.1.7.1.1.1, B.2.1.7.1.2.1 and B.2.2.1.2.1) 
 
o.  Units of Measurement (FDACVM GFI#188 B.1.9.2.1, B.1.9.3.1, B.2.1.7.1.1.1, 
B.2.1.7.1.2.1, B.2.1.7.1.3.1.1, B.2.2.1.1.1, B.2.2.1.2.1  and B.3.5.1.1) 
 
p.  Dosage Forms (FDACVM GFI#188 B.2.2.2) 
 
The VICH list that has been developed by the Controlled  Lists of Terms Implementation 
Task Force is a comprehensive list that includes dosage forms specific to veterinary 
medicinal  products.  At this stage however, in an interim phase, it is agreed to use a less 
detailed list that is in operation by the FDA. 
 
5  Contains Non-Binding Recommendations 
This interim phase should end when the relevant International Dosage Forms list 
becomes available. This list is being developed in the frame of ISO prEN 11239 Health 
informatics  Identification of Medicinal Products  Data elements and structures to 
uniquely identify pharmaceutical dose forms, units of presentation and routes of 
administration.  When the relevant ISO list contains the specific veterinary dosage 
forms that are included in the VICH Dosage Forms list, the Maintenance Committee (see 
III.2.2) should verify and decide whether to replace the interim  FDA list with the relevant 
ISO list. 
 
q.  Administrators of the VMP (FDACVM GFI#188 B.2.4) 
 
r.  Off-Label Use Coding System (FDACVM GFI#188 B.2.5.1) 
 
The explanation  for off-label use and its corresponding  codes can be obtained by 
sequentially  answering 9 questions about the species, route of administration,  overdose, 
underdose, treatment regimen, indications,  storage conditions,  expiration and any other. 
 
s.  VeDDRA Terms (FDACVM GFI#188 B.3.2) 
 
The Veterinary Dictionary for Drug Regulatory Activities (VeDDRA) is the clinical 
dictionary  to describe adverse clinical  manifestations (FDACVM GFI#188 B.3.2 Adverse 
Clinical  Manifestations).  The list, as well as the full explanation  and Guidance Notes on 
the Use of VeDDRA Terminology  for Reporting Adverse Events in Animals, can be 
downloaded from the European Medicines Agency (EMA) Website: 
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/docum
ent_listing_000173.jsp&mid=WC0b01ac058002dea6. 
 
t.  Exposure and Onset Time (FDACVM GFI#188 B.3.4) 
 
u.  Attending Veterinarians Causality Assessment (FDACVM GFI#188 B.5.1.) 
 
v.  Document Types (FDACVM GFI#188 B.7.1.1) 
 
w. Dose Denominator Qualifiers (FDACVM GFI#188 B.2.1.7.1.2.1) 
 
x.  Accuracy of No. of Animals (FDACVM GFI#188 B.3.2.1.1) 
 
Lists Specific to FDACVM June 2013 Revision 
 
aa. Attached Document Name (FDACVM GFI#188 B.7.1) 
 
bb. ICSR Observation Locator Codes (FDACVM GFI#188 NA) 
 
cc. Explanation for Linkage (FDACVM GFI#188 B.6.1.1) 
 
6  Contains Non-Binding Recommendations 
A.36  ISO 3-Character Country Codes (FDACVM GFI#188 A.1, A.2.1, A.3.1, 
A.3.2, A.4.1, and B.2.1.2) 
 
A.20  ATCvet Code  Information Only (FDACVM GFI#188  B.2.1.3) 
 
A.35  US States & Territory Codes (US Only) (FDACVM GFI#188  A.1, A.2.1, 
A.3.1, and A.3.2) 
 
A.5  Domestic and Foreign Report Categories (US Only) (FDACVM GFI#188 
B.8.2.6) 
 
A.26  Profile Identifier Code Vocabulary (US Only) (FDACVM GFI#188 B.8.2.7) 
 
A.34  Report Identifier (US Only) (FDACVM GFI#188 B.8.2.5) 
 
A.29  List of Package Types (US Only) (FDACVM GFI#188 B.2.6.3.1 and B.2.6.4.1) 
 
A.42  National Drug Codes System (US Only) (FDACVM GFI#188 B.2.1.1) 
 
A.38  Substance Registration System Active Ingredient Codes (US Only) 
(FDACVM GFI#188 B.2.2.1.3) 
 
A.28  ORA District Field Offices (US Only) (FDACVM GFI#188 B.2.6.5) 
 
A.43  FDA CVM Internal Product Problem/Medication Error Terms (US Only) 
(FDACVM GFI#188 B.3.2) 
 
A.44  FDA CVM Internal Adverse Event Terms (US Only) (FDACVM GFI#188 
B.3.2) 
 
A.18  List of Manufacturer Site Identifiers (US Only) (FDACVM GFI#188 
B.2.6.1.1) 
 
III.2.  Maintenance 
 
III.2.1. General Requirements 
 
The  lists  should  be  periodically  reviewed.      Revisions  of  the  lists  do  not  require  the 
revision  of  the  guidance  titled  Pharmacovigilance  of  Veterinary  Medicinal  Products: 
Electronic  Standards  for  Transfer  of  Data  (GFI#214),  FDACVM  GFI#188,  or  this 
guidance. 
   
7  Contains Non-Binding Recommendations 
The procedure for the yearly maintenance of VeDDRA is published on the EMA Website 
(http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/docu
ment_listing_000173.jsp&mid=WC0b01ac058002dea6).    The  representatives  of  all 
VICH regions are formally invited to participate in the yearly meeting for the revision of 
VeDDRA. 
 
FDACVM-specific lists may be revised independently  by FDA CVM as needed. 
 
III.2.2 Maintenance Committee 
 
The maintenance of the Controlled List of Terms should take place annually in a meeting.   
In general, this meeting should take place by teleconference, web-conference and/or e-
mail exchange.  Face-to-face meetings can be considered if warranted. Ad-hoc meetings 
can be considered if urgent matters arise. The preparatory work should take place for 
each individual list by the lead regions (see Annex B).  Implementation of the changes to 
the lists should be done within realistic time frames. 
 
The  meeting  members  should  discuss  and  conclude  by  consensus  on the proposals to 
revise the lists. 
 
Revisions should be maintained consistent at least with the following  principles, 
 
  revisions should be made only when justified  by rational scientific need, 
 
  revisions should be made with strict version control and backward compatibility,  and 
 
  revisions should be consistent with technical requirements. 
 
The revised lists should replace the Annexed Lists of this guidance and should be 
submitted for publication  on the FDA CVM Website within 30 days of finalization. 
 
FDACVM-specific lists may be revised independently  by FDA CVM as needed. 
 
ANNEX A - Standard Lists 
 
As these lists are subject to yearly change, we direct you to the FDA CVM website for the most 
current versions of the lists. 
http://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm212682.htm. 
 
8  Contains Non-Binding Recommendations 
ANNEX B - GL30  CONTROLLED LISTS OF TERMS MAINTENANCE 
WORKSHARING  LEAD REGIONS 
 
LIST  GFI #188 REFERENCE  LEAD REGION 
a.  Reporter Categories  A.3.1.1 and A.3.2.1  USA (FDA/CVM) 
b.  RA Identifier Codes  A.4.1  USA (FDA/CVM) 
c.  Type of Submission  A.4.4.1  USA (FDA/CVM) 
d.  Type of Information in Report  A.4.4.3  USA (FDA/CVM) 
e.  Attending Veterinarians Health  B.1.2.1  USA (FDA/CVM) 
  Status Assessment 
f.  Species  B.1.3  EU (EMA) 
g.  Breeds  B.1.4  EU (EMA) 
h.  Gender  B.1.5  USA (FDA/CVM) 
i.  Reproductive Status  B.1.6  USA (FDA/CVM) 
j.  Female Physiological  Status  B.1.7  USA (FDA/CVM) 
k.  Precision Categories  B.1.8.1 and B.1.9.1  USA (FDA/CVM) 
l.  RA Assessment  B.2.1.6  USA (FDA/CVM) 
m.  Route of Exposure  B.2.1.7  USA (FDA/CVM)  
n.  Units of Presentation  B.2.1.7.1.1.1 ,  USA (FDA/CVM) 
B.2.1.7.1.2.1 and  
B.2.2.1.2.1  
o.  Units of Measurement  B.1.9.2.1, B.1.9.3.1,  USA (FDA/CVM) 
B.2.1.7.1.1.1, 
B.2.1.7.1.2.1, 
B.2.1.7.1.3.1.1, 
B.2.2.1.1.1, 
B.2.2.1.2.1 and 
B.3.5.1.1 
p.  Dosage Forms  B.2.2.2  CANADA - 
Veterinary Drugs 
Directorate 
q.  Administrators  of the VMP  B.2.4  USA (FDA/CVM) 
r.  Off-Label Use Coding System  B.2.5.1  JAPAN (JMAFF) 
s.  VeDDRA Terms  B.3.2  EU (EMA) 
t.  Exposure and Onset Time  B.3.4  USA (FDA/CVM) 
u.  Attending Veterinarians Causality  B.5.1  USA (FDA/CVM) 
  Assessment 
v.  Document Types  B.7.1.1  USA (FDA/CVM) 
w.  Dose Denominator Qualifiers  B.2.1.7.1.2.1  USA (FDA/CVM) 
x.  Accuracy of No. of Animals  B.3.2.1.1  USA (FDA/CVM) 
   
   
9  Contains Non-Binding Recommendations 
Lists Specific to FDA CVM GFI#188 June 2013 Revision 
 
LIST  GFI #188 REFERENCE  LEAD REGION 
aa.  Attached Document Name  B.7.1  USA (FDA/CVM) 
bb.  ICSR Observation Locator Codes  NA  USA (FDA/CVM) 
cc.  Explanation  for Linkage  B.6.1.1  USA (FDA/CVM) 
A.36  ISO 3-Character Country Codes  A.1, A.2.1, A.3.1,  USA (FDA/CVM) 
A.3.2, A.4.1, and 
B.2.1.2 
A.20  ATCvet Code  Information Only  B.2.1.3  USA (FDA/CVM) 
A.35  US States & Territory Codes  A.1, A.2.1, A.3.1, and  USA (FDA/CVM) 
  (US Only)  A.3.2 
A.5  Domestic and Foreign Report  B.8.2.6  USA (FDA/CVM) 
  Categories (US Only) 
A.26  Profile Identifier Code Vocabulary  B.8.2.7  USA (FDA/CVM) 
  (US Only) 
A.34  Report Identifier (US Only)  B.8.2.5  USA (FDA/CVM) 
A.29  List of Package Types (US Only)  B.2.6.3.1 and  USA (FDA/CVM) 
B.2.6.4.1 
A.42  National Drug Codes System  B.2.1.1  USA (FDA/CVM) 
  (US Only) 
A.38  Substance Registration System  B.2.2.1.3  USA (FDA/CVM) 
  Active Ingredient Codes (US Only) 
A.28  ORA District Field Offices  B.2.6.5  USA (FDA/CVM)  
  (US Only) 
A.43  FDA CVM Internal Product  B.3.2  USA (FDA/CVM) 
  Problem/Medication  Error Terms 
  (US Only) 
A.44  FDA CVM Internal Adverse Event  B.3.2  USA (FDA/CVM) 
  Terms (US Only) 
A.18  List of Manufacturer Site Identifiers  B.2.6.1.1  USA (FDA/CVM) 
  (US Only) 
 
10