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 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. Procedures for maintenance submissions are still in development and under discussion between the EMA and industry stakeholders. 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 trained EVMPD 2.0 user since 2005 and supports your daily XEVMPD business by:
- Registration of medicinal product data in XEVMPD
- Hosting and management of XEVPRM data
- XEVPRM lifecycle management
- XEVMPD consulting and training
- Data analysis and data migration
- Publishing of Product Information
Download XEVMPD Flyer