Template for submission of comments for the Veterinary
Dictionary for Drug Regulatory Activities (VeDDRA)
standard list for EudraVigilance Veterinary (EVVet)
Comments from:
Name of organisation or individual
When completed, this form should be sent to the European Medicines Agency electronically, in Word or
Excel format (not PDF) via e-mail to: [email protected] by 1 March of each year.
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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
1. Proposals for combined VeDDRA list of clinical terms for reporting suspected adverse
reactions in animals and humans to veterinary medicinal products (EMA/CVMP/10418/2009)
Please include your proposals in the table below (either word or excel), where applicable indicating the appropriate line number and/or SOC/HLT/PT/LLT
terms and key codes.
Current
Current
VeDDRA line
no. (if
applicable)
Current
System
Current
Organ
SOC
Class
Key
Proposed
Proposed
SOC
SOC Key
(SOC)
Term
Current
Current
High
Current
Level
HLT
Term
Key
Proposed
Proposed
Preferred
Current
Proposed
Proposed
HLT Key
Term
PT Key
PT Term
PT Key
HLT
Term
(HLT)
(PT)
Low
Level
Term
Current
Current
Proposed
Proposed
LLT Key
LLT
LLT Key
Term
Type1
Proposed
Term
Type
Action2
1
(LLT)
Term
Please add more rows if needed. Please do not merge cells.
For excel version of above table, please open the following link:
VeDDRA_Proposals.x
ls
1
2
Term Type: A=animal; C=common; H=human.
Action: A=addition; D=deletion; M=modification.
Template for submission of comments for the Veterinary Dictionary for Drug
Regulatory Activities (VeDDRA) standard list for EudraVigilance Veterinary (EVVet)
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