EMA’s PRIME draft toolbox: Consultation ends July 2021

Action required: Consultation for the EMA PRIority MEdicine (PRIME) draft toolbox guidance closes 31st July 2021. What is PRIME about? The European Medicines Agency (EMA) launched the PRIority MEdicines (PRIME) scheme in March 2016. The scheme was launched to provide early and enhanced scientific and regulatory support for medicines that target an unmet medical need. …

EMA’s Union Product Database user research

Union Product Database: EMA’s Veterinary Medicines Division released user research. In January 2021, the EMA released some interesting findings about how stakeholders might want to make use of the Union Product Database (UPD). What is the UPD? According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain …

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 …

EMA provides latest on Article 57

Action required before end of January 2021. Since 1 February 2020, when the United Kingdom withdrew from the European Union (EU), the UK has become a ‘third country’ as far as the EU is concerned. A withdrawal agreement has provided direction for the transition period, ending 31 December 2020 (European Commission, Notice to Stakeholders, 13 …

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 …