#214 
 
Pharmacovigilance of Veterinary 
Medicinal Products Electronic 
Standards for Transfer of Data 
 
VICH GL35 
 
Guidance for Industry 
 
This version of the guidance replaces the version made available December 2014.  The 
document has been revised to update information and harmonize with the March 2023 revision 
of VICH GL35 to the extent consistent with FDA regulations. 
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, Rm. 1061, Rockville, MD 
20852.  All written comments should be identified with the Docket No. FDA-2011-D-0588. 
 
For further information regarding this document, contact the Division of Pharmacovigilance and 
Surveillance (HFV-240), Office of Surveillance and Compliance, Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl, 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, 7500 Standish Place, 
Rockville, MD 20855, and may be viewed on the Internet at https://www.fda.gov/animal-
veterinary, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or 
http://www.regulations.gov. 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Veterinary Medicine 
January 2024  
 
VICH GL35 (R1) (PHARMACOVIGILANCE: ESTD) 
March 2023 
Revision 1 at Step 9 
For Implementation at Step 7 
 
 
 
 
 
 
 
P  
HARMACOVIGILANCE OF
V M  
  ETERINARY  EDICINAL 
P : 
RODUCTS
E S  
LECTRONIC  TANDARDS FOR
T D  
  RANSFER OF  ATA
(R 1) 
EVISION 
 
 
 
 
 
Revision at Step 9  
 
Adopted at Step 7 of the VICH Process by the VICH Steering Committee 
in March 2023  
for implementation by March 2024 
 
 
This Guideline has been developed and revised by the appropriate VICH Expert Working Group 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.  Contains Nonbinding Recommendations 
 
Table of Contents 
 
I.  Introduction ....................................................................................................................... 1 
II.  Scope of Electronic Standards for Information Exchange ........................................... 1 
III.  Recommendations to Ensure Secure Transmission ....................................................... 2 
IV.  Definition of the Electronic Message Structure ............................................................. 2 
V.  Relationships (Cardinality) Between the Data Elements .............................................. 2 
VI.  Electronic Submission of Animal Adverse Events and Product Problems    
Electronic Transmission Implementation Specifications FDA Validation    
Procedure Document ........................................................................................................ 3 
VII.  Electronic Submission of Animal Adverse Events and Product Problems    
Electronic Transmission Implementation Specifications FDA Step By Step 
Document ........................................................................................................................... 3 
VIII.  Wrapper Data Elements ................................................................................................... 3 
Annex A.  Data Model .................................................................................................................. 8 
Annex B.  Field Length and Data Type by GL42 Data Elements........................................... 16 
Annex C.  Field Length and Data Type for GL35 HL7 Wrapper Data Elements ................ 25 
 
i 
  Contains Nonbinding Recommendations 
 
Pharmacovigilance of Veterinary Medicinal Products: Electronic 
Standards for Transfer of Data1 
 
Guidance for Industry 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on FDA 
or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
responsible for this guidance as listed on the title page. 
 
I.  Introduction 
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.  GL35 and associated documents described below, Electronic 
Submission of Animal Adverse Events Electronic Transmission Implementation Specifications 
VICH Validation Procedure Document (USFDACVM Regional Annex) and Electronic 
Submission of Animal Adverse Events Electronic Transmission Implementation Specifications 
VICH Step By Step Document (USFDACVM Regional Annex), should be used to develop the 
electronic system.2 
In general, FDAs guidance documents 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 of Electronic Standards for Information Exchange 
The scope of recommended electronic standards for exchange of veterinary pharmacovigilance 
data between VICH RAs and MAHs includes but is not limited to: 
-  Recommendation to ensure secure transmission 
 
1 This guidance, to the extent consistent with FDA regulations, harmonizes with the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) guideline 
document, Pharmacovigilance of Veterinary Medicinal Products Electronic Standards for Transfer of Data 
(Revision 1) (VICH GL35(R1)), but has some FDA-specific application. 
2 Contact CVMAESupport@fda.hhs.gov for these documents. 
 
1 
  Contains Nonbinding Recommendations 
 
-  Definition of the electronic message structure 
-  Relationships (cardinality) between the data elements 
-  Recommended additional vocabularies for electronic transmission and implementation of 
GL42 
-  Business and schema validation rules and field descriptors specification for the data 
defined in GL35 and GL42. 
III.  Recommendations to Ensure Secure Transmission 
Regional exchange of pharmacovigilance information preferably occurs through a Gateway that 
follows the ICH M2 Gateway recommendation for the Electronic Standards for the Transfer of 
Regulatory Information (ESTRI-Gateway) in order to provide for an automated and secure way 
of transmission including all aspects of confidentiality, authentication, integrity and non-
repudiation of all transactions in pharmacovigilance.  MAHs should adhere to the RAs gateway 
specifications. 
IV.  Definition of the Electronic Message Structure 
The message format is XML. 
 
The technical document entitled Electronic Submission of Animal Adverse Events - Electronic 
Transmission Implementation Specifications VICH Step By Step Document (USFDACVM 
Regional Annex) (herein known as the FDA Step By Step Document) was developed to be in 
line with ISO 27953-1.  The adverse event processing system of each MAH and RA should be 
compliant with GL35 and the FDA Step By Step Document including the Regional Annexes. 
The purpose of the FDA Step By Step Document is to provide directions to assist users, 
reporters, and technical staff in completing a well-formed electronic message for AER and PPR 
for veterinary medicinal products.  The GL42 document has recommended a standard set of 
definitions to describe the data elements that should be submitted for compliant AERs and PPRs.  
The FDA Step By Step Document provides a translation and mapping of GL42 compliant 
adverse event and product problem elements into an electronic message.  The GL42 data 
elements comprise the payload of the message. 
These submissions are intended to be sent electronically to the receivers through their Electronic 
Submissions Gateway (ESG), and upon receipt they will be processed by the receiver unique 
systems.  In addition to the payload information, the electronic message also contains 
wrapper information (also known as envelope information). 
The structure of the wrapper is specified in GL35 and the FDA Step By Step Document.  It 
contains the data elements recommended in GL35 and the XML structure as set forth in the FDA 
Step By Step Document. 
V.  Relationships (Cardinality) Between the Data Elements 
The recommended relationships (cardinality) between the data elements are set forth in GL35.  
The data model diagrams are found in Annex A to GL35. 
 
2 
  Contains Nonbinding Recommendations 
 
VI.  Electronic Submission of Animal Adverse Events and Product Problems Electronic 
Transmission Implementation Specifications FDA Validation Procedure Document 
The technical document entitled Electronic Submission of Animal Adverse Events - Electronic 
Transmission Implementation Specifications VICH Validation Procedure Document 
(USFDACVM Regional Annex) (herein known as the FDA Validation Procedure Document) 
describes the schema and business validation rules that will be performed on the AER and PPR 
message.  The purpose of the FDA Validation Procedure Document is to provide directions to 
assist users, reporters, and technical staff in the successful validation of the electronic message 
for AER and PPR for veterinary medicinal products. 
VII.  Electronic Submission of Animal Adverse Events and Product Problems Electronic 
Transmission Implementation Specifications FDA Step By Step Document 
The FDA Step By Step Document describes the mapping of the data elements listed in GL42 and 
GL35 into the AER and PPR XML message that is ISO 27953-1 schema compliant. 
VIII.  Wrapper Data Elements 
The following are the data elements to be included in the batch and transmission wrappers of the 
message.  
Section B.8.1 Batch Wrapper 
The batch wrapper is established in line with ISO 27953-1 specification. 
Section B.8.1.1 Batch Number/Identifier 
The Batch Number/Identifier information identifies the collection of reports in this batch as a 
complete submission message.  The concatenation of Batch Number/Identifier Root and 
Extension uniquely identifies each batch of reports.  It is the senders responsibility to define and 
assign this identifier, as each batch submission should have a unique identifier.  A Batch 
Number/Identifier should be supplied even if only one AER or PPR is within the batch. 
Section B.8.1.1.1 Batch Number/Identifier  Root 
This is the submitting organizations unique sender identifier.  This data element identifies the 
sender of the AER or PPR message, e.g., the MAH unique ID or RA unique ID. 
Section B.8.1.1.2 Batch Number/Identifier  Extension 
The Batch Number/Identifier Extension is a unique tracking number within the sender system 
assigned to a specific batch file transmitted by the sender.  The form and format of this element 
is up to the creator of the batch. 
Section B.8.1.2 Batch Sender 
This information identifies the sender who is responsible for any technical communications 
between receiver and sender regarding the batch transmission of the AER or PPR message. 
 
3 
  Contains Nonbinding Recommendations 
 
Section B.8.1.2.1 Batch Sender  Root 
This is the submitting organizations unique sender identifier.  This data element identifies the 
sender of the AER or PPR message, e.g., the MAH unique ID or RA unique ID. 
Section B.8.1.2.2 Batch Sender  Extension 
The Batch Sender Extension is the organization name. 
Section B.8.1.2.3 Batch Sender  Title 
The Batch Sender Title is a field that contains the title of the sender who is responsible for any 
corresponding communications regarding the transmission batch. 
Section B.8.1.2.4 Batch Sender  Last name 
The Batch Sender Last name is a field that contains the last name of the sender who is 
responsible for any corresponding communications regarding the transmission batch. 
Section B.8.1.2.5 Batch Sender  First name 
The Batch Sender First name is a field that contains the first name of the sender who is 
responsible for any corresponding communications regarding the transmission batch. 
Section B.8.1.2.6 Batch Sender  Telephone 
The Batch Sender Telephone is a field that contains the telephone number of the sender who is 
responsible for any corresponding communications regarding the transmission batch. 
Section B.8.1.2.7 Batch Sender  Fax 
The Batch Sender Fax is a field that contains the fax number of the sender who is responsible 
for any corresponding communications regarding the transmission batch. 
Section B.8.1.2.8 Batch Sender  e-mail 
The Batch Sender e-mail is a field that contains the e-mail address of the sender (or an equally 
functional group e-mail address) who is responsible for any corresponding communications 
regarding the transmission batch. 
Section B.8.1.3 Batch Receiver 
The Batch Receiver information identifies the receiver of the batch message. 
Section B.8.1.3.1 Batch Receiver  Root 
This is the submitting organizations unique receiver identifier.  This data element identifies 
the receiver of the AER or PPR message, e.g., the MAH unique ID or RA unique ID. 
 
4 
  Contains Nonbinding Recommendations 
 
Section B.8.1.3.2 Batch Receiver  Extension 
The Batch Receiver Extension is a field that contains the organization name. 
Section B.8.1.4 Date of Batch Creation 
The Date of Batch Creation indicates the date the batch report is created. 
Section B.8.1.5 VICH AER Version Number 
The VICH AER Version Number indicates the AER Message Version and Release Number on 
which this batch is based. 
Section B.8.2 Transmission Wrapper 
Section B.8.2.1 Message Number 
The Message Number information identifies the message.  The concatenation of Message 
Number Root and Extension uniquely identifies each message.  The message creator should 
ensure that this uniquely assigned identifier will never be used in another message.  It is the 
senders responsibility to define and assign this number, as each message should have a unique 
number. 
Section B.8.2.1.1 Message Number  Root 
The Message Number Root is the submitting organizations unique sender identifier.  This 
data element identifies the sender of the AER or PPR message, e.g., the MAH unique ID or RA 
unique ID. 
Section B.8.2.1.2 Message Number  Extension 
The Message Number  Extension is a field that contains the uniquely assigned message 
identifier for the specified message (this is not the Unique Adverse Event Report Identification 
Number).  Each submitted message should have a unique identifier assigned regardless of the 
Type of Submission.  This field format is up to the creator of the message. 
Section B.8.2.2 Message Sender) 
Section B.8.2.2.1 Message Sender  Root 
This is the submitting organizations unique sender identifier.  This data element identifies the 
sender of the AER or PPR message, e.g., the MAH unique ID or RA unique ID. 
Section B.8.2.2.2 Message Sender  Extension 
The Message Sender Extension is a field that contains the organization name of the message 
sender who is defined as the Pharmacovigilance Contact Person in charge of the AER or PPR 
message. 
 
5 
  Contains Nonbinding Recommendations 
 
Section B.8.2.2.3 Message Sender  Title 
The Message Sender Title is a field that contains the title of the message sender who is defined 
as the Pharmacovigilance Contact Person in charge of the AER or PPR message. 
Section B.8.2.2.4 Message Sender  Last name 
The Message Sender Last name is a field that contains the last name of the message sender 
who is defined as the Pharmacovigilance Contact Person in charge of the AER or PPR message. 
Section B.8.2.2.5 Message Sender  First name 
The Message Sender First name is a field that contains the first name of the message sender 
who is defined as the Pharmacovigilance Contact Person in charge of the AER or PPR message. 
Section B.8.2.2.6 Message Sender  Telephone 
The Message Sender Telephone is a field that contains the telephone number of the message 
sender who is defined as the Pharmacovigilance Contact Person in charge of the AER or PPR 
message. 
Section B.8.2.2.7 Message Sender  Fax 
The Message Sender Fax is a field that contains the fax number of the message sender who is 
defined as the Pharmacovigilance Contact Person in charge of the AER or PPR message. 
Section B.8.2.2.8 Message Sender  e-mail 
The Message Sender e-mail is a field that contains the e-mail address of the message sender 
(or an equally functional group e-mail address) who is defined as the Pharmacovigilance Contact 
Person in charge of the AER or PPR message. 
Section B.8.2.3 Message Receiver 
Section B.8.2.3.1 Message Receiver  Root 
The Message Receiver Root is a field that contains the receiver of the AER or PPR message, 
e.g., the MAH unique ID or RA unique ID. 
Section B.8.2.4 Date of Message Creation 
This is the date on which the message inside the batch was created.  This date can be the same as 
the date of batch creation. 
Section B.8.2.5 Report Identifier 
This field is used for the sender to identify additional information that may be used to process the 
information into their IT systems. 
 
6 
  Contains Nonbinding Recommendations 
 
Section B.8.2.6 Domestic vs Foreign Report Category 
The Domestic vs Foreign Report Category indicates if the specified AER or PPR is a domestic 
or foreign report relative to the receiver. 
Section B.8.2.7 Profile Identifier 
The Profile Identifier (Profile ID) Code contains details about the type of report contained in 
this message payload.  When creating this message, the value for this field should be from the 
Profile Identifier Vocabulary list. 
Field Descriptions 
Presented in Annex C are the field lengths and data types for all the wrapper data elements that 
will serve as the basis for the message. 
Corrigendum 
Annex A and B (Sections B.2, B.3, and B.4) have been updated to be consistent with the 
Electronic Transmission Implementation Specification VICH Step By Step Document (Version 
1.0.2  November 05, 2014).  The VICH Step By Step Document links B.3.9 Previous Exposure 
to the VMP, B.3.10 Previous AE to the VMP, B.4.1 Did AE Abate After Stopping the VMP, and 
B.4.2 Did the AE Reappear After Stopping the VMP to Section B.2 VMPs Data and Usage, i.e., 
to the product information. 
Please note that the number system was not updated to reflect the number system of B.2.  The 
working group determined that if the number system was updated then substantial updates would 
be necessary for GL42 and the Step By Step Document, as well as RA specific documents.    
 
7 
  Contains Nonbinding Recommendations 
 
Annex A.  Data Model 
 
 
 
8  Contains Nonbinding Recommendations 
 
 
 
9  Contains Nonbinding Recommendations 
 
 
 
10  Contains Nonbinding Recommendations 
 
 
 
11  Contains Nonbinding Recommendations 
 
 
 
12  Contains Nonbinding Recommendations 
 
 
 
13  Contains Nonbinding Recommendations 
 
 
 
14  Contains Nonbinding Recommendations 
 
 
15  Contains Nonbinding Recommendations 
 
Annex B.  Field Length and Data Type by GL42 Data Elements 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
Administrative and Identification Information  Section A 
Regulatory Authority (RA)  A.1     
RA name  A.1.1  100  Open ended text 
Street address  A.1.2  100  Open ended text 
City  A.1.3  50  Open ended text 
State/county  A.1.4  USA  Code List 
State  15  Open ended text 
County  80 
Mail/zip code  A.1.5  35  Open ended text 
Country (3-character country  A.1.6  15  Code List 
codes ISO 3166) 
Marketing Authorization Holder (MAH) (Sender)  Section A.2 
MAH Information  A.2.1     
  Business name  A.2.1.1  100  Open ended text 
  Street address  A.2.1.2  100  Open ended text 
  City  A.2.1.3  50  Open ended text 
  State/county  A.2.1.4  USA  Code List 
State  15  Open ended text 
County  80 
  Mail/zip code  A.2.1.5  35  Open ended text 
  Country (3-character country  A.2.1.6  15  Code List 
  codes ISO 3166) 
Person Acting on Behalf of MAH  A.2.2     
  Title  A.2.2.1  50  Open ended text 
  First name  A.2.2.2  50  Open ended text 
  Last name  A.2.2.3  50  Open ended text 
  Telephone Number  A.2.2.4  20  Open ended text 
  Fax Number  A.2.2.5  20  Open ended text 
  e-mail address  A.2.2.6  100  Open ended text 
Person(s) Involved in AER (Reporter)  Section A.3 
Primary Reporter  A.3.1     
  Primary Reporter Category  A.3.1.1  15 (code)  Code List 
80 (code 
description/ 
term) 
 
16  Contains Nonbinding Recommendations 
 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
  Last name  A.3.1.2  50  Open ended text 
  First name  A.3.1.3  50  Open ended text 
  Telephone Number  A.3.1.4  20  Open ended text 
  Fax Number  A.3.1.5  20  Open ended text 
  e-mail address  A.3.1.6  100  Open ended text 
  Business name  A.3.1.7  100  Open ended text 
  Street address  A.3.1.8  100  Open ended text 
  City  A.3.1.9  50  Open ended text 
  State/county  A.3.1.10  USA  Code List 
State  15  Open ended text 
County  80 
  Mail/zip code  A.3.1.11  35  Open ended text 
  Country (3-character country  A.3.1.12  15  Code List 
  codes ISO 3166) 
Other Reporter  A.3.2     
Other Reporter Category  A.3.2.1  15 (code)  Code List 
80 (code 
description/ 
term) 
Last name  A.3.2.2  50  Open ended text 
First name  A.3.2.3  50  Open ended text 
Telephone Number  A.3.2.4  20  Open ended text 
Fax Number  A.3.2.5  20  Open ended text 
e-mail address  A.3.2.6  100  Open ended text 
Business name  A.3.2.7  100  Open ended text 
Street address  A.3.2.8  100  Open ended text 
City  A.3.2.9  50  Open ended text 
State/county  A.3.2.10  USA  Code List 
State  15  Open ended text 
County  80 
Mail/zip code  A.3.2.11  35  Open ended text 
Country (3-character country  A.3.2.12  15  Code List 
codes ISO 3166) 
AER Information (Sender Investigation/Report Information)  Section A.4 
Unique Adverse Event Report  A.4.1  60  Open ended text 
Identification Number 
 
17  Contains Nonbinding Recommendations 
 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
Original Receive Date  A.4.2  19  Date 
(YYYYMMDD) 
Date of Current Submission  A.4.3  19  Date 
(YYYYMMDD) 
Type of Report  Section A.4.4 
Type of Submission  A.4.4.1  15 (code)  Code List 
80 (code 
description/ 
term) 
Reason for Nullification Report  A.4.4.2  200  Open ended text 
Type of Information in Report  A.4.4.3  15 (code)  Code List 
80 (code 
description/ 
term) 
Description of the AE  Section B 
Animal Data  Section B.1 
Number of Animals Treated  B.1.1  12  Integer 
Number of Animals Affected  B.1.2  12  Integer 
Attending Veterinarian's  B.1.2.1  15 (code)  Code List 
Assessment of Animal Health  80 (code 
Status Prior to VMP  description/ 
term) 
Species  B.1.3  15 (code)  Code List 
160 (code 
description/ 
term) 
Breed  B.1.4.1.1  15 (code)  Code List 
Breed  250 (code 
(Purebred) and  description/ 
B.1.4.2.1  term) 
Breed 
(Crossbred) 
Gender  B.1.5  15 (code)  Code List 
80 (code 
description/ 
term) 
Reproductive Status  B.1.6  15 (code)  Code List 
80 (code 
description/ 
term) 
 
18  Contains Nonbinding Recommendations 
 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
Female Physiological Status  B.1.7  15 (code)  Code List 
80 (code 
description/ 
term) 
Weight  Section B.1.8 
Measured, Estimated, Unknown  B.1.8.1  15 (code)  Code List 
Weights  80 (code 
description/ 
term) 
Minimum Weight in Kilograms  B.1.8.2  12  Numeric 
(nnnnnnnn.nnn) 1 
Minimum Weight Unit  B.1.8.2.1  kg   
Maximum Weight in Kilograms  B.1.8.3  12  Numeric 
(nnnnnnnn.nnn) 1 
Maximum Weight Unit  B.1.8.3.1  kg   
Age  Section B.1.9 
Measured, Estimated, Unknown  B.1.9.1  15 (code)  Code List 
Age  80 (code 
description/ 
term) 
Minimum Age  B.1.9.2  12  Numeric 
(nnnnnnnnn.nn) 2 
Minimum Age Units  B.1.9.2.1  15  Code List 
Maximum Age  B.1.9.3  12  Numeric 
(nnnnnnnnn.nn) 2 
Maximum Age Units  B.1.9.3.1  15  Code List 
VMP Data and Usage  Section B.2 
Registered or Brand Name  B.2.1  200  Open ended text 
Product Code  B.2.1.1  50  Open ended text 
Registration Identifier  B.2.1.2  50  Open ended text 
Anatomical Therapeutic Chemical  B.2.1.3  10  Open ended text 
Vet (ATCvet) Code 
Company or MAH  B.2.1.4  100  Open ended text 
MAH Assessment  B.2.1.5  4000  Open ended text 
 
1 The decimal point is floating but cant exceed 3 decimals or total of 12 characters (which includes the decimal 
point). 
2 The decimal point is floating but cant exceed 2 decimals or total of 12 characters (which includes the decimal 
point). 
 
19  Contains Nonbinding Recommendations 
 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
RA Assessment  B.2.1.6     
RA Assessment Term  B.2.1.6.1  15 (code)  Code List 
80 (code 
description/ 
term) 
Explanation Relating to  B.2.1.6.1.1  4000  Open ended text 
Assessment 
Previous Exposure to the VMP  B.3.9  5  Boolean/Null Flavor 
Previous AE to VMP  B.3.10  5  Boolean/Null Flavor 
B.4 Dechallenge-Rechallenge  B.4.1  5  Boolean/Null Flavor 
Information - Did AE Abate After 
Stopping the VMP? 
B.4 Dechallenge-Rechallenge  B.4.2  5  Boolean/Null Flavor 
Information - Did AE Reappear 
After Re-introduction of the VMP? 
Route of Exposure & Dosage Information  Section B.2.1.7 & Section B.2.2 
Route of Exposure  B.2.1.7  15 (code)  Code List 
80 (code 
description/ 
term) 
Dose Per Administration  B.2.1.7.1     
Numeric Value for Dose  B.2.1.7.1.1  12  Numeric 
(Numerator)  (nnnnnnn.nnnn) 3 
Units of Value for Dose  B.2.1.7.1.1.1  15 (code)  Code List 
(Numerator)  80 (code 
description/ 
term) 
Numeric Value for Dose  B.2.1.7.1.2  12  Numeric 
(Denominator)  (nnnnnnn.nnnn) 3 
Units of Value for Dose  B.2.1.7.1.2.1  15 (code)  Code List 
(Denominator)  80 (code 
description/ 
term) 
Interval of Administration  B.2.1.7.1.3     
Numeric Value for Interval  B.2.1.7.1.3.1  12  Integer 
of Administration 
 
3 The decimal point is floating but cant exceed 4 decimals or total of 12 characters (which includes the decimal 
point). 
 
20  Contains Nonbinding Recommendations 
 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
Units of Value for the  B.2.1.7.1.3.1.1  15 (code)  Code List 
Interval of  80 (code 
Administration  description/t
erm) 
Date of First Exposure  B.2.1.7.1.3.2  19  Date (YYYY, 
YYYYMM, or 
YYYYMMDD) 
Date of Last Exposure  B.2.1.7.1.3.3  19  Date (YYYY, 
YYYYMM, or 
YYYYMMDD) 
Active Ingredient(s)  B.2.2     
Active Ingredient(s)  B.2.2.1  200  Open ended text 
Numeric Value for Strength  B.2.2.1.1  12  Numeric 
(Numerator)  (nnnnnnn.nnnn) 3 
Units for Numeric Value  B.2.2.1.1.1  15 (code)  Code List 
for Strength (Numerator)  80 (code 
description/ 
term) 
Numeric Value for Strength  B.2.2.1.2  12  Numeric 
(Denominator)  (nnnnnnn.nnnn) 3 
Units for Numeric Value  B.2.2.1.2.1  15 (code)  Code List 
for Strength  80 (code 
(Denominator)  description/ 
term) 
Active Ingredient Code  B.2.2.1.3  15  Code List 
Dosage Form  B.2.2.2  15 (code)  Code List 
80 (code 
description/ 
term) 
Lot Number(s)  B.2.3  35  Open ended text 
Expiration Date  B.2.3.1  19  Date (YYYY, 
YYYYMM, or 
YYYYMMDD) 
Who Administered the VMP  B.2.4  15 (code)  Code List 
80 (code 
description/ 
term) 
Use According to Label  B.2.5  5  Boolean/Null Flavor 
Explanation for Off-Label Use  B.2.5.1     
 
21  Contains Nonbinding Recommendations 
 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
Was the target species Off- B.2.5.1.1  5  Yes/No Information 4 
Label? 
Was the route of administration  B.2.5.1.2  5  Yes/No Information 4 
Off-Label? 
Was the animal overdosed?  B.2.5.1.3  5  Yes/No Information 4 
Was the animal underdosed?  B.2.5.1.4  5  Yes/No Information 4 
Was the treatment regimen Off- B.2.5.1.5  5  Yes/No Information 4 
Label? 
Was the indication Off-Label?  B.2.5.1.6  5  Yes/No Information 4 
Was the storage condition Off- B.2.5.1.7  5  Yes/No Information 4 
Label? 
Was the product expired?  B.2.5.1.8  5  Yes/No Information 4 
Was there any other Off-Label  B.2.5.1.9  5  Yes/No Information 4 
issue? 
Manufacturing/Product Defect Information  Section B.2.6 
Manufacturing Site Identifier  B.2.6.1  50  Open ended text 
Number 
Manufacturers Identifier Type  B.2.6.1.1  50  OID for DUNS or 
FEI Number 
Manufacturing Date  B.2.6.2  19  Date 
(YYYYMMDD) 
Number of Defective Items  B.2.6.3  12  Integer 
Defective Item Unit  B.2.6.3.1  15 (code)  Code list 
80 (code 
description/ 
term) 
Number of Items Returned  B.2.6.4  12  Integer 
Returned Item Units  B.2.6.4.1  15 (code)  Code list 
80 (code 
description/ 
term) 
ORA District Field Office  B.2.6.5  15 (code)  Code list 
80 (code 
description/ 
term) 
 
4 Yes will be presented True in the message using a Boolean snippet.  No Information will be presented in 
the message using a null Flavor snippet. 
 
22  Contains Nonbinding Recommendations 
 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
Adverse Event Data  Section B.3 
Narrative of AE  B.3.1  20,000  Open ended text 
Adverse Clinical Manifestations  B.3.2  15 (code)  Code List 
250 (code 
description/ 
term) 
Number of Animal  B.3.2.1  12  Integer 
Accuracy of the Number of  B.3.2.1.1  15 (code)  Code List 
Animals  80 (code 
description/ 
term) 
Date of Onset of AE/PP found date  B.3.3  19  Date (YYYY, 
YYYYMM, or 
YYYYMMDD) 
Length of Time between Exposure  B.3.4  15 (code)  Code List 
to VMP & Onset of AE  80 (code 
description/ 
term) 
Duration of AE  B.3.5     
Duration  B.3.5.1  12  Numeric 
(nnnnnnn.nnnn) 3 
Duration Time Units  B.3.5.1.1  15 (code)  Code List 
80 (code 
description/ 
term) 
Serious AER  B.3.6  5  Boolean 
Treatment of AE   B.3.7  5  Boolean/Null Flavor 
Outcome to Date  B.3.8     
Ongoing  B.3.8.1  12  Integer 
Recovered/Normal  B.3.8.2  12  Integer 
Recovered with Sequela  B.3.8.3  12  Integer 
Died  B.3.8.4  12  Integer 
Euthanized  B.3.8.5  12  Integer 
Unknown  B.3.8.6  12  Integer 
Veterinary Assessment of AE  Section B.5 
Attending Veterinarians  B.5.1  15 (code)  Code List 
Assessment of AE  80 (code 
description/ 
term) 
 
23  Contains Nonbinding Recommendations 
 
Field 
GL42  Length 
GL 42 Section Title  Section  (maximum  Data Type 
Number  length  
characters) 
Report Number(s) of Linked Report(s)  Section B.6 
Unique Adverse Event Report  B.6.1  60  Open ended text  
Identification Number 
  Explanation for Linkage  B.6.1.1  15 (code)  Code List 
80 (code 
description/ 
term) 
Supplemental Documents -- Section B.7 
Attached Document Filename  B.7.1  255  Open ended text 
Attached Document Type  B.7.1.1  15 (code)  Code List 
80 (code 
description/ 
term) 
   
 
24  Contains Nonbinding Recommendations 
 
Annex C.  Field Length and Data Type for GL35 HL7 Wrapper Data Elements 
Field 
Length 
GL35 Section 
GL35 Section Title  (maximum  Data Type 
Number 
length  
characters) 
HL7 ICSR Wrapper Data Elements -- Section B.8 
Batch Wrapper  B.8.1     
Batch Number/Identifier  B.8.1.1     
Batch Number/Identifier  Root  B.8.1.1.1  60  Open ended text 
Batch Number/Identifier  
B.8.1.1.2  100  Open ended text 
Extension 
Batch Sender   B.8.1.2     
Batch Sender  Root  B.8.1.2.1  60  Open ended text 
Batch Sender  Extension  B.8.1.2.2  100  Open ended text 
Batch Sender  Title  B.8.1.2.3  50   Open ended text 
Batch Sender  Last name  B.8.1.2.4  50   Open ended text 
Batch Sender  First name  B.8.1.2.5  50   Open ended text 
Batch Sender  Telephone  B.8.1.2.6  20   Open ended text 
Batch Sender  Fax  B.8.1.2.7  20   Open ended text 
Batch Sender  e-mail  B.8.1.2.8  100   Open ended text 
Batch Receiver  B.8.1.3     
Batch Receiver  Root  B.8.1.3.1  60   Open ended text 
Batch Receiver  Extension  B.8.1.3.2  100   Open ended text 
YYYYMMDDHHM
MSS+/-ZZZZ 
**NOTE:  HHMMSS 
represents hours, 
Date of Batch Creation  B.8.1.4  19  
minutes, and seconds, 
and +/-ZZZZ 
represents GMT 
offset  
VICH AER Version Number  B.8.1.5  15   Open ended text 
Transmission Wrapper  B.8.2     
Message Number   B.8.2.1     
Message Number  Root  B.8.2.1.1  60  Open ended text 
Message Number  Extension  B.8.2.1.2  100   Open ended text 
Message Sender  B.8.2.2     
Message Sender  Root  B.8.2.2.1  60  Open ended text 
Message Sender  Extension  B.8.2.2.2  100   Open ended text 
Message Sender  Title  B.8.2.2.3  50  Open ended text 
 
25  Contains Nonbinding Recommendations 
 
Field 
Length 
GL35 Section 
GL35 Section Title  (maximum  Data Type 
Number 
length  
characters) 
Message Sender  Last name  B.8.2.2.4  50   Open ended text 
Message Sender  First name  B.8.2.2.5  50   Open ended text 
Message Sender  Telephone  B.8.2.2.6  20   Open ended text 
Message Sender  Fax  B.8.2.2.7  20   Open ended text 
Message Sender  e-mail  B.8.2.2.8  100   Open ended text 
Message Receiver  B.8.2.3     
Message Receiver  Root  B.8.2.3.1  60   Open ended text 
YYYYMMDDHHM
MSS+/-ZZZZ 
**NOTE:  HHMMSS 
represents hours, 
Date of Message Creation  B.8.2.4  19 
minutes, and seconds, 
and +/-ZZZZ 
represents GMT 
offset  
Report Identifier  B.8.2.5  7  Open ended text 
15 (code) 
Domestic vs Foreign Report  80 (code 
B.8.2.6  Code List 
Category  description/ 
term) 
Profile Identifier  B.8.2.7  60   Open ended text 
 
 
26