Although still under development, the UPD Public Portal offers a first glimpse of what will come: better access to medicinal product information for the public. Let’s have a look at what is on offer. The homepage mainly gives access to the substance and medicine index as well as the search functionality. As expected, under the …
Tag Archives: Union Product Database
Union Product Database – EMA’s Agile Approach?
With the pressure mounting to implement the New Veterinary Regulations (NVR) which came into force 28th January 2022, releases of the Union Product Database (UPD) to be implemented under the NVR are getting more frequent. In true software development fashion, is the EMA using the Agile approach to get solutions out more frequently and much …
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New Veterinary Regulations – Volume of Sales
Only days to go – The New Veterinary Regulation is coming into force on 28th January 2022. Time is running out for Marketing Authorisation Holders (MAHs), regulators and solution providers. The New Veterinary Regulation (NVR) is coming into force on 28/January/2022. Part of the NVR is the requirement for MAHs to provide information about the …
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Digital Transformation for the benefit of the equine world
Digital transformation (DX) is the adaptation of digital technology, the transformation of services and business processes to replace manual or outdated non-digital processes. However, DX is much more than the integration of digital technology. DX might even move technology and processes to the edge of what is currently possible, the last mile where technologies meets, …
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New EMA’s Union Product Database production release
The EMA released version 01.02 of the Union Product Database on 16th March 2021. As part of the New Veterinary Regulations (NVR) implementation, the EMA is developing a Union Product Database (UPD) to allow the management of veterinary medicinal products in the EU. The UPD has been welcomed by many and will certainly improve the …
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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 …
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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 …
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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 …
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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 …
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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 …
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