Veterinary pharmacovigilance: important change relating to the submission of reports of adverse events
As a marketing authorisation holder you are obliged to submit reports of adverse events to the medicinal product authorities. There are detailed instructions on what has to be reported and how exactly this should be done. The database in which you enter these reports is called Eudravigilance Veterinary (EVVet). Below you can read about an important change relating to the submission of reports of adverse events in EVVet.
From now on reports must be submitted with a VICH-compliant Unique Adverse Event Report Identification Number
The EMA is launching an improved pharmacovigilance system for veterinary medicinal products on 28 January 2022. EVVet will then also be amended in line with the Veterinary Medicinal Products Regulation and will then comply with the reporting requirements developed by the Veterinary International Conference on Harmonization (VICH).
The EMA recommends that VICH-compliant Worldwide Case Numbers are used as soon as possible, before the Veterinary Medicinal Products Regulation comes into effect. These codes identify reports of adverse events. As a result reports submitted before 28 January 2022 can be easily linked to the corresponding reports submitted after that date.
How does that actually work?
In the VICH format the Unique Adverse Event Report Identification Number of the report (which is currently still referred to as the Worldwide Case Number) will be constructed in the following way:
'3 character country code'–'8 character MAH or RA code'–'unique number'
(see VICH GL 42)
An example of a VICH-compliant Unique Adverse Event Report Identification Number is: NLD-NLDCBGBD-20211234.
- The 3 character country code must be in accordance with ISO 3166.
- If, as a marketing authorisation holder, you already have an 8 character MAH code for submitting reports in other regions, you will be able to use this code in the EU in the future as well.
- If you do not yet have an 8 character MAH code, you can create one yourself by referring to the EU VICH adverse event report implementation guide.
- The unique number can be made up of letters and numbers.
You can find more information about the VICH reporting requirements for pharmacovigilance in VICH Guideline 35, VICH Guideline 42 and the VICH 'step-by-step' document. These documents can be found on the VICH website. You can also find information in the EU VICH adverse event report implementation guide on the EMA website.
Stay up to date
During the coming months the Veterinary Medicinal Products Unit will be organising various online information meetings to answer your questions about the Veterinary Medicinal Products Regulation. Please register for (one of) the information meetings! (in Dutch)