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

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

#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) (P HARMACOVIGILANCE : ESTD)
March 2023
Revision 1 at Step 9
For Implementation at Step 7
P HARMACOVIGILANCE OF
V ETERINARY 	M EDICINAL
P RODUCTS :
E LECTRONIC 	S TANDARDS FOR
T RANSFER OF 	D ATA
(R EVISION 	1)
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.

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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

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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, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s 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.

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- 	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.

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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 sender’s 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 organization’s 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.

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Section B.8.1.2.1 Batch Sender – Root
This is the submitting organization’s 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 organization’s 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.

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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
sender’s 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 organization’s 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 organization’s 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.

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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.

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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.

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Annex A. Data Model

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Annex B. Field Length and Data Type by GL42 Data Elements
GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
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
State – 15
County – 80
Code List
Open ended text
Mail/zip code 	A.1.5 	35 	Open ended text
Country (3-character country
codes ISO 3166)
A.1.6 	15 	Code List
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
State – 15
County – 80
Code List
Open ended text
Mail/zip code 	A.2.1.5 	35 	Open ended text
Country (3-character country
codes ISO 3166)
A.2.1.6 	15 	Code List
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)
80 (code
description/
term)
Code List

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GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
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
State – 15
County – 80
Code List
Open ended text
Mail/zip code 	A.3.1.11 	35 	Open ended text
Country (3-character country
codes ISO 3166)
A.3.1.12 	15 	Code List
Other Reporter 	A.3.2
Other Reporter Category 	A.3.2.1 	15 (code)
80 (code
description/
term)
Code List
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
State – 15
County – 80
Code List
Open ended text
Mail/zip code 	A.3.2.11 	35 	Open ended text
Country (3-character country
codes ISO 3166)
A.3.2.12 	15 	Code List
AER Information (Sender Investigation/Report Information) – Section A.4
Unique Adverse Event Report
Identification Number
A.4.1 	60 	Open ended text

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GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
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)
80 (code
description/
term)
Code List
Reason for Nullification Report 	A.4.4.2 	200 	Open ended text
Type of Information in Report 	A.4.4.3 	15 (code)
80 (code
description/
term)
Code List
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
Assessment of Animal Health
Status Prior to VMP
B.1.2.1 	15 (code)
80 (code
description/
term)
Code List
Species 	B.1.3 	15 (code)
160 (code
description/
term)
Code List
Breed 	B.1.4.1.1
Breed
(Purebred) and
B.1.4.2.1
Breed
(Crossbred)
15 (code)
250 (code
description/
term)
Code List
Gender 	B.1.5 	15 (code)
80 (code
description/
term)
Code List
Reproductive Status 	B.1.6 	15 (code)
80 (code
description/
term)
Code List

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GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
Female Physiological Status 	B.1.7 	15 (code)
80 (code
description/
term)
Code List
Weight – Section B.1.8
Measured, Estimated, Unknown
Weights
B.1.8.1 	15 (code)
80 (code
description/
term)
Code List
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
Age
B.1.9.1 	15 (code)
80 (code
description/
term)
Code List
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
Vet (ATCvet) Code
B.2.1.3 	10 	Open ended text
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 can’t exceed 3 decimals or total of 12 characters (which includes the decimal
point).
2 The decimal point is floating but can’t exceed 2 decimals or total of 12 characters (which includes the decimal
point).

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GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
RA Assessment 	B.2.1.6
RA Assessment Term 	B.2.1.6.1 	15 (code)
80 (code
description/
term)
Code List
Explanation Relating to
Assessment
B.2.1.6.1.1 	4000 	Open ended text
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
Information - Did AE Abate After
Stopping the VMP?
B.4.1 	5 	Boolean/Null Flavor
B.4 Dechallenge-Rechallenge
Information - Did AE Reappear
After Re-introduction of the VMP?
B.4.2 	5 	Boolean/Null Flavor
Route of Exposure & Dosage Information – Section B.2.1.7 & Section B.2.2
Route of Exposure 	B.2.1.7 	15 (code)
80 (code
description/
term)
Code List
Dose Per Administration 	B.2.1.7.1
Numeric Value for Dose
(Numerator)
B.2.1.7.1.1 	12 	Numeric
(nnnnnnn.nnnn) 3
Units of Value for Dose
(Numerator)
B.2.1.7.1.1.1 	15 (code)
80 (code
description/
term)
Code List
Numeric Value for Dose
(Denominator)
B.2.1.7.1.2 	12 	Numeric
(nnnnnnn.nnnn) 3
Units of Value for Dose
(Denominator)
B.2.1.7.1.2.1 	15 (code)
80 (code
description/
term)
Code List
Interval of Administration 	B.2.1.7.1.3
Numeric Value for Interval
of Administration
B.2.1.7.1.3.1 	12 	Integer
3 The decimal point is floating but can’t exceed 4 decimals or total of 12 characters (which includes the decimal
point).

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GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
Units of Value for the
Interval of
Administration
B.2.1.7.1.3.1.1 	15 (code)
80 (code
description/t
erm)
Code List
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
(Numerator)
B.2.2.1.1 	12 	Numeric
(nnnnnnn.nnnn) 3
Units for Numeric Value
for Strength (Numerator)
B.2.2.1.1.1 	15 (code)
80 (code
description/
term)
Code List
Numeric Value for Strength
(Denominator)
B.2.2.1.2 	12 	Numeric
(nnnnnnn.nnnn) 3
Units for Numeric Value
for Strength
(Denominator)
B.2.2.1.2.1 	15 (code)
80 (code
description/
term)
Code List
Active Ingredient Code 	B.2.2.1.3 	15 	Code List
Dosage Form 	B.2.2.2 	15 (code)
80 (code
description/
term)
Code List
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)
80 (code
description/
term)
Code List
Use According to Label 	B.2.5 	5 	Boolean/Null Flavor
Explanation for Off-Label Use 	B.2.5.1

Contains Nonbinding Recommendations
22
GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
Was the target species Off-
Label?
B.2.5.1.1 	5 	Yes/No Information 4
Was the route of administration
Off-Label?
B.2.5.1.2 	5 	Yes/No Information 4
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-
Label?
B.2.5.1.5 	5 	Yes/No Information 4
Was the indication Off-Label? 	B.2.5.1.6 	5 	Yes/No Information 4
Was the storage condition Off-
Label?
B.2.5.1.7 	5 	Yes/No Information 4
Was the product expired? 	B.2.5.1.8 	5 	Yes/No Information 4
Was there any other Off-Label
issue?
B.2.5.1.9 	5 	Yes/No Information 4
Manufacturing/Product Defect Information – Section B.2.6
Manufacturing Site Identifier
Number
B.2.6.1 	50 	Open ended text
Manufacturer’s 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)
80 (code
description/
term)
Code list
Number of Items Returned 	B.2.6.4 	12 	Integer
Returned Item Units 	B.2.6.4.1 	15 (code)
80 (code
description/
term)
Code list
ORA District Field Office 	B.2.6.5 	15 (code)
80 (code
description/
term)
Code list
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.

Contains Nonbinding Recommendations
23
GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
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)
250 (code
description/
term)
Code List
Number of Animal 	B.3.2.1 	12 	Integer
Accuracy of the Number of
Animals
B.3.2.1.1 	15 (code)
80 (code
description/
term)
Code List
Date of Onset of AE/PP found date 	B.3.3 	19 	Date (YYYY,
YYYYMM, or
YYYYMMDD)
Length of Time between Exposure
to VMP & Onset of AE
B.3.4 	15 (code)
80 (code
description/
term)
Code List
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)
80 (code
description/
term)
Code List
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 Veterinarian’s
Assessment of AE
B.5.1 	15 (code)
80 (code
description/
term)
Code List

Contains Nonbinding Recommendations
24
GL 42 Section Title
GL42
Section
Number
Field
Length
(maximum
length –
characters)
Data Type
Report Number(s) of Linked Report(s) – Section B.6
Unique Adverse Event Report
Identification Number
B.6.1 	60 	Open ended text
Explanation for Linkage 	B.6.1.1 	15 (code)
80 (code
description/
term)
Code List
Supplemental Documents -- Section B.7
Attached Document Filename 	B.7.1 	255 	Open ended text
Attached Document Type 	B.7.1.1 	15 (code)
80 (code
description/
term)
Code List

Contains Nonbinding Recommendations
25
Annex C. Field Length and Data Type for GL35 HL7 Wrapper Data Elements
GL35 Section Title GL35 Section
Number
Field
Length
(maximum
length –
characters)
Data Type
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 –
Extension B.8.1.1.2 	100 	Open ended text
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
Date of Batch Creation 	B.8.1.4 	19
YYYYMMDDHHM
MSS+/-ZZZZ
**NOTE: HHMMSS
represents hours,
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

Contains Nonbinding Recommendations
26
GL35 Section Title GL35 Section
Number
Field
Length
(maximum
length –
characters)
Data Type
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
Date of Message Creation 	B.8.2.4 	19
YYYYMMDDHHM
MSS+/-ZZZZ
**NOTE: HHMMSS
represents hours,
minutes, and seconds,
and +/-ZZZZ
represents GMT
offset
Report Identifier 	B.8.2.5 	7 	Open ended text
Domestic vs Foreign Report
Category B.8.2.6
15 (code)
80 (code
description/
term)
Code List
Profile Identifier 	B.8.2.7 	60 	Open ended text