New EMA veterinary product information template

Action required: The EMA invites comments for the new product information template by 14/May/2021. The EMA just released a new product information template for public consultation. Besides smaller adjustments, the template mainly addresses changes required in line with the New Veterinary Regulations (NVR) that is coming into effect January 2022. Although no firm date for …

EMA’s Union Product Database implementation guide updated (again!)

Action required: Union Product Database implementation guide is available for consultation until 21/March/2021. Today, I shall look at three of the many changes proposed. The first important update. Under the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). In previous blogs we looked …

UPDated – EMA updated Union Product Database implementation guide

According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). In July 2020 the EMA published the UPD access policy (EMA/198149/2020), which outlines who gets access to which data stored in the UPD. It outlines how all parties can meet their obligations …

UP-to-Date – EMA’s Union Product Database implementation guide

What is the UPD? According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain a Union Product Database (UPD). With that in mind, implementation acts are required laying out electronic exchange mechanism and data format, database functionality and interface/API as well as detailed specifications of the data …

uNcoVeR the EU’s New Veterinary Regulations

Uncovering the New Veterinary Regulations (NVR) EU 2019/6 for Regulatory Information Management (RIM) is not quite straight forward. The NVR will become applicable from 28th January 2022, bringing additional burden but also benefits to the veterinary industry. It contains new measures for increasing the availability and safety of veterinary medicines and is one of the …