Calculation of dose factor to be submitted to the Union Product Database (UPD) - Scientific guideline

The guideline has been developed to provide specific guidance on the considerations and calculations related to the dose factor which alongside de submission of the yearly sales data will allow to calculate and publish the yearly reported incidences of adverse reactions for each veterinary medicinal product.

Keywords: Calculation of dose factor, UPD, veterinary medicinal products, EVV, incidence, adverse events reporting, annual volume of sales data

Current version

Guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD)

Adopted Consultation dates: 13/10/2023 to 13/11/2023 Reference Number: EMA/CVMP/PhVWPV/399363/2023 Legal effective date: 15/12/2023

Document history

Draft guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD)

Draft Consultation dates: 13/10/2023 to 13/11/2023 Reference Number: EMA/CVMP/PhVWPV/399363/2023

Overview of comments received on Guideline on the calculation of dose factor to be submitted to the Union Product Database (UPD) (EMA/CVMP/PhVWPV/399363/2023)

Reference Number: EMA/CVMP/PhVWPV/470818/2023