The EMA will launch an improved EVVet system on 28 January 2022 to align it with the Veterinary Medicines Regulation (Regulation (EU) 2019/6) and associated requirements fo the Union Pharmacovigilance Database.

The system will use the pharmacovigilance reporting standards developed by the Veterinary International Conference on Harmonization (VICH), which will replace the data format described in the Data Elements Guideline (DEG) currently in use.

Since 30 November 2021, the BVL has been assigning case numbers (DEG: Unique Case Registration Number [UCRN]/ VICH: Unique Adverse Event Report Identification Number) in a new format for newly generated AE reports. This is in preparation for the changeover of the data format for AE reports from DEG to VICH and will enable the smooth assignment of follow-up reports received in EVVET from 28.01.2022 onwards to cases reported (to BVL) in December 2021 and January 2022.

All organisations in the EU that generate AE reports but are not using VICH compliant AE identifiers by now, are requested to adapt their case numbers to the new data format as soon as possible. This can be found in the VICH GL42 under point A.4.1 - According to this paragraph, the number is composed of the three-letters ISO code of the country of occurence of the AE, an eight-digit ID of the marketing authorisation holder or the authority and any free text, each separated by a hyphen.

Marketing authorisation holders who already have an eight-digit ID should use this. If no eight-digit ID exists so far, it should be generated using the own routing ID with the help of a CRC32 hash generator (tools are available online).

The EU VICH Implementation Guide (externer Link; PDF; 612 KB) recommends that marketing authorisation holders place their routing ID at the beginning of the free text.

Hypothetical example:

https://crccalc.com/ Source: https://crccalc.com/

For a marketing authorisation holder with the routing ID "EXAMPLE", the following case numbers would result for cases that occurred in Germany:

DEU-51A96585-EXAMPLExxxxx

According to the EVVET3 Business Rules (externer Link; XLS; 162 KB), the case number can be up to 60 characters long, and certain special characters are allowed in the free text (which may contain up to 47 characters).

As of 28 January 2022, cases with case numbers in DEG format will no longer be accepted by the EMA. Follow Ups to cases sent before this date are excepted by this rule as long as the two or three letters ISO code in the beginning of the case number corresponds to the land of occurence.

If you have any questions about case number generation, please contact us at 316@bvl.bund.de.

Year of issue 2021
Date 08.12.2021

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