PHARMACOVIGILANCE OF VETERINARY MEDICINAL PRODUCTS

Electronic Standards for Transfer of Data

VICH GL35

June 22, 2010

Introduction

The objective of this guideline is to provide standards to construct a single electronic

message to transmit GL42 contents to all regions.

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 definition of the pharmacovigilance information has

been established within GL24, GL30 and GL42, this guideline defines the electronic

standards for transfer of data.

In order to allow for electronic exchange of this information between stakeholders,

further specification of the field descriptors and their relationships, including agreement

on format of the electronic message is essential.

Scope of Electronic Standards for Information Exchange

The scope of electronic standards for exchange of veterinary pharmacovigilance data

between VICH RA and MAH includes but is not limited to:

- Recommendation to ensure secure transmission

- Definition of the electronic message structure

- Relationships (cardinality) between the data elements

- Establishment of additional vocabularies for electronic transmission and

implementation of GL24, GL30, and GL42

- Business and schema validation rules and field descriptors specification for the

data defined in GL24, GL30, GL35 and GL42

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 allow for an

automated and secure way including all aspects of confidentiality, authentication,

integrity and non-repudiation of all transactions in pharmacovigilance. MAHs will need

to adhere to the RAs gateway specifications.
Definition of the Electronic Message Structure

For the basis of describing the messaging structure, the VICH Pharmacovigilance

Working Group recommends the adoption a single standard, i.e., the International

Standard ISO 27953-1. The message format is XML.

The US FDA CVM technical document entitled “Electronic Submission of Animal

Adverse Events - HL7 ICSR - Electronic Transmission Implementation Specifications

[Step By Step] (herein known as the Step By Step Document) is available on the US FDA

CVM website. This document will serve as the core document from which VICH will

develop its own specific VICH Step By Step Document in line with ISO 27953-1 for

implementation. The unique adverse event processing system of each MAH and RA will

need to be compliant with the VICH Step By Step Document (to be developed).

The purpose of this VICH Step By Step Document is to provide directions to assist users,

reporters, and technical staff in completing a well formed electronic message for animal

veterinary medicinal products adverse event reports (AER). The GL42 document has

established a standard set of definitions to describe the data elements that need to be

submitted for compliant adverse event reports. This document provides a translation and

mapping of GL42 compliant adverse event 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 RAs through their

Electronic Submissions Gateway (ESG) and upon receipt they will be processed by the

RAs unique systems. In addition to the “payload” information, the electronic message

also contains “wrapper” information (also known as envelope information). Unique and

specific information will be included in the wrappers of the electronic message as

specified by the RAs. The purpose is so that the electronic message can be processed

appropriately according to each RA’s administrative needs. These unique and specific

data should be specified in each RA’s technical documents.

Relationships (Cardinality) Between the Data Elements

The relationships (cardinality) between the data elements are defined in GL42, the VICH

Step By Step Document, VICH Validation Procedure Document (see description below),

and Annex A. The draft data model diagrams are found in Annex A. Implementers

should review and study all 3 of these documents to carefully understand the relationships

between the data elements.

For repeatable fields, the RA should provide the maximum number of arrays that RA

electronic systems will accept.
Business and Schema Validation Rules, Field Descriptors

Specification for the Data Defined in GL42 and Wrapper

Information and Relationships (Cardinality)

The US FDA CVM technical document entitled “Electronic Submission of Animal

Adverse Events HL7 Individual Case Safety Report (ICSR) Electronic Transmission

Implementation Specifications (herein known as the Validation Procedures) is available

on the US FDA CVM website. This document will serve as the core document from

which VICH will develop its own specific VICH Validation Procedures for

implementation. The unique adverse event processing system of each MAH and RA will

need to be compliant with the VICH Validation Procedures Document (to be developed).

Field Descriptions

Presented in Annex B are the field lengths and data types for all the GL42 that

will serve as the basis for discussion in the implementation.
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 60 Open ended text

Street address 100 Open ended text

City 35 Open ended text

State/county USA State – 15

County - 80

Single Choice Code

List

Open ended text

Mail/zip code 15 Open ended text

Country (3 character country

codes ISO 3166)

15 single choice code list

Marketing Authorization Holder (MAH) (Sender) -- Section A.2

MAH Information A.2.1

Business name 60 Open ended text

Street address 100 Open ended text

City 35 Open ended text

State/county USA State – 15

County - 80

Single Choice Code

List

Open ended text

Mail/zip code 15 Open ended text

Country (3 character country

codes ISO 3166)

15 single choice code list

Person Acting on Behalf of

MAH

A.2.2

Title 50 Open ended text

First name 35 Open ended text

Last name 50 Open ended text

Telephone

18

Formatted numeric for

USA; open ended text

for non-USA

Fax

18

Formatted numeric for

USA; open ended text

for non-USA

e-mail 100 Open ended text

Person(s) Involved in AER (Reporter) – Section A.3

Primary Reporter Information A.3.1

First name 35 Open ended text

Last name 50 Open ended text

Telephone

18

Formatted numeric for

USA; open ended text
GL 42 Section Title

GL42 Section

Number

Field Length

(maximum

length –

characters)

Data Type

for non-USA

Fax

18

Formatted numeric for

USA; open ended text

for non-USA

e-mail 100 Open ended text

Business name 60 Open ended text

Street address 100 Open ended text

City 35 Open ended text

State/county USA State – 15

County - 80

Single Choice Code

List

Open ended text

Mail/zip code 15 Open ended text

Country (3 character country

codes ISO 3166)

15 Single choice code list

Primary Reporter Category A.3.1.1 15 (code)

80 (code

description/term)

Single choice code list

Other Reporter Information A.3.2

First name 35 Open ended text

Last name 50 Open ended text

Telephone

18

Formatted numeric for

USA; open ended text

for non-USA

Fax

18

Formatted numeric for

USA; open ended text

for non-USA

e-mail 100 Open ended text

Business name 60 Open ended text

Street address 100 Open ended text

City 35 Open ended text

State/county USA State – 15

County - 80

Single Choice Code

List

Open ended text

Mail/zip code 15 Open ended text

Country (3 character country

codes ISO 3166)

15 Single choice code list

Other Reporter Category A.3.2.1 15 (code)

80 (code

description/term)

Single choice code list

AER Information (Sender Investigation/Report Information) – Section A.4

Unique Adverse Event

Identification Number

A.4.1 60 Open ended text
GL 42 Section Title

GL42 Section

Number

Field Length

(maximum

length –

characters)

Data Type

Original Receive Date A.4.2 19 Date

Date of Current Submission A.4.3 19 Date

Type of Report – Section A.4.4

Type of Submission & Code

A.4.4.1

15 (code)

80 (code

description/term)

Single choice code list

Reason for Nullification Report A.4.4.2 200 Open ended text

Type of Information in Report &

Code A.4.4.3

15 (code)

80 (code

description/term)

Single choice code list

Description of Animal Data Information – 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 Health Status

Prior to VMP & Code

B.1.2.1

15 (code)

80 (code

description/term)

Single choice code list

Species (Type of Species) &

Code B.1.3

15 (code)

80 (code

description/term)

Single choice code list

Breed & Code B.1.4.1.1

Breed

(Purebreed)

and B.1.4.2,1

Breed

(Crossbred)

15 (code)

80 (code

description/term)

Multiple choice code

list

Gender & Code

B.1.5

15 (code)

80 (code

description/term)

Single choice code list

Reproductive Status & Code

B.1.6

15 (code)

80 (code

description/term)

Single choice code list

Female Physiological Status &

Code B.1.7

15 (code)

80 (code

description/term)

Single choice code list

Animal Weight – Section B.1.8

Weight Measured, Estimated or

Unknown & Code B.1.8.1

15 (code)

80 (code

description/term)

Single choice code list

Minimum Weight

B.1.8.2 12

Numeric

(nnnnnnnnn.nn)

Minimum Weight Unit kg

Maximum Weight

B.1.8.3 12

Numeric

(nnnnnnnnn.nn)

Maximum Weight Unit kg
GL 42 Section Title

GL42 Section

Number

Field Length

(maximum

length –

characters)

Data Type

Animal Age – Section B.1.9

Age Measured, Estimated or

Unknown & Code B.1.9.1

15 (code)

80 (code

description/term)

Single choice code list

Minimum Age

B.1.9.2 12

Numeric

(nnnnnnnnn.nn)

Minimum Age Units (code) B.1.9.2.1 15 Single choice code list

Maximum Age

B.1.9.3 12

Numeric

(nnnnnnnnn.nn)

Maximum Age Units (code) B.1.9.3.1 15 Single choice code list

VMP Data and Usage – Section B.2

Registered Name or Brand Name B.2.1 200 Open ended text

Product Code (Product NDC

Number or Unique ID)

B.2.1.1 20 Open ended text

Registration Identifier B.2.1.2 35 Open ended text

Anatomical Therapeutic

Chemical Vet (ATCvet) Code

B.2.1.3 10 Open ended text

Company or MAH B.2.1.4 60 Open ended text

MAH Assessment B.2.1.5 250 Open ended text

RA Assessment B.2.1.6 Not Applicable Not Applicable

Explanation Relating to

Assessment

B.2.1.6.1 Not Applicable Not Applicable

Route of Exposure & Dosage Information – Section B.2.1.7 & Section B.2.2

Route of Exposure (Route of

Administration)

B.2.1.7

15 (code)

80 (code

description/term)

Single choice code list

Dose Per Administration B.2.1.7.1

Numeric Value for Dose B.2.1.7.1.1 12 Numeric

(nnnnnnn.nnnn)

Units of Value for Dose B.2.1.7.1.1.1 15 (code)

80 (code

description/term)

single choice code list

Interval of Administration B.2.1.7.1.2

Numeric Value for Interval

of Administration

B.2.1.7.1.2.1 12

Integer

Units of Value for the

Interval of

Administration

B.2.1.7.1.2.1.1 15 (code)

80 (code

description/term)

Single choice code list

Date of First Exposure B.2.1.7.1.2.2 19 Date

Date of Last Exposure B.2.1.7.1.2.3 19 Date

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)
GL 42 Section Title

GL42 Section

Number

Field Length

(maximum

length –

characters)

Data Type

Units for Numeric Value

for Strength (Numerator)

B.2.2.1.1.1 15 (code)

80 (code

description/term)

Single choice code list

Numeric Value for Strength

(Denominator)

B.2.2.1.2 12 Numeric

(nnnnnnn.nnnn)

Units for Numeric Value

for Strength (Denominator)

B.2.2.1.2.1 15 (code)

80 (code

description/term)

Single choice code list

Active Ingredient Code B.2.2.1.2 15 Single choice code list

Dosage Form & Code B.2.2.2 15 (code)

80 (code

description/term)

Single choice code list

Manufacturing/Product Defect Information – Section B.2.3 & B.2.3.6

Lot Number(s) B.2.3 35 Open ended text

Expiration Date B.2.3.1 19 Date

Administration – Section B.2.4

Who Administered the VMP &

Code

B.2.4 15 (code)

80 (code

description/term)

Single choice code list

Label Usage – Section B.2.5

Use According to Label B.2.5 5 Boolean

Explanation for Off-Label Use

& Code

B.2.5.1 12 Integer

Adverse Event Data – Section B.3

Narrative of AE B.3.1 20,000 Open ended text

Adverse Clinical Manifestations

(AER Term Name(s) & Code(s)) B.3.2

15 (code)

250 (code

description/term)

Multiple choice 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)

Single choice code list

Date of Onset of AE (AE Start

Date)

B.3.3 19 Date

Length of Time between

Exposure to VMP & Onset of

AE

B.3.4

15 (code)

80 (code

description/term)

Single choice code list

Duration of AE B.3.5

Duration (Time) B.3.5.1

12

Numeric

(nnnnnnn.nnnn)

Duration Time Units B.3.5.1.1 15 (code)

80 (code

description/term)

Single choice code list

Serious AER Reported B.3.6 5 Boolean

Treatment of AE B.3.7 5 Boolean
GL 42 Section Title

GL42 Section

Number

Field Length

(maximum

length –

characters)

Data Type

Outcome to Date B.3.8 12 Integer

Previous Exposure to the VMP B.3.9 5 Boolean

Previous AE to VMP B.3.10 5 Boolean

Dechallenge - Rechallenge Information – Section B.4

Did AE Abate After Stopping

the VMP?

B.4.1 5 Boolean

Did AE Reappear After Reintroduction of the VMP?

B.4.2 5 Boolean

Veterinary Assessment of AE – Section B.5

Attending Veterinarian’s

Assessment of AE B.5.1

15 (code)

80 (code

description/term)

Single choice code list

Supplemental Documents -- Section B.7

Attached Document Filename B.7.1 256 Open ended text

Attached Document Type

B.7.1.1

15 (code)

80 (code

description/term)

Single choice code list