The new EU Pharmacovigilance legislation constitutes one of the biggest changes in European Drug law since 1995, according to the European Medicines Agency (EMA). Significant changes are introduced into Pharmacovigilance and Regulatory Affairs business practice to enhance patient safety and to increase efficiency and transparency with regard to Pharmacovigilance.
As one of the consequences, Marketing Authorisation Holders (MAH) have been obliged to provide detailed structured data using the XML standard for all human medicinal products authorised in EU/EEA to the Extended Eudravigilance Medicinal Product Dictionary (xEVMPD) by July 02, 2012 the latest.
The new standard that needs to be followed is the Extended EudraVigilance Product Report Message – xEVPRM. The specification has been published in a revised format in March 2012 and 2013. The latest update was published End of January 2014 and includes now also the procedures required for maintenance of data.
Data required include detailed information on administrative, product-related and substance-related data. In addition, the current version of the product information (SPC) must be provided.
Exalon is fully trained EVMPD 2.0 user since 2005 and xEVMPD user since 2012. We support your daily xEVMPD business by:
- Registration of medicinal product data in XEVMPD
- Hosting of xEVPRM data
- xEVMPDifecycle management
- xEVMPD consulting and training
- Data analysis and data migration
- Publishing of Product Information
Download xEVMPD Flyer