Pharmacovigilance and the xEVMPD/QPPV
If you are a Marketing Authorisation Holder (MAH) for any medicinal product, authorised or registered within the EU, you need to submit information relating to the Pharmacovigilance of these medicines; regardless of where you are located.
xEVMPD (Extended EudraVigilance Medicinal Product Dictionary) allows the European Medicines Agency (EMA) to rapidly analyse this data to identify product issues, ensuring patient safety thorough the European region.
Why you need to comply with the PV directive
The xEVMPD is a comprehensive drug dictionary linking all products, variants, and synonyms for active substances that became mandatory on 2 July 2012 for all MA holders.
All submissions to the xEVMPD are done via the online portal. The initial medicinal information required includes details of the MA, therapeutic indications, API data, excipient data, SmPCs, posology, method of administration, etc. It is part of the ongoing MAH’s responsibility to ensure these details are updated through formal notifications.
How Woodley BioReg can help you
For many pharmaceutical and generic drug manufacturers who hold MAs the requirements to complete xEVMPD present a problem in terms of knowledge, and training in the use, of the system, resource to complete the activity, and collation of the information required.
Woodley BioReg has a specialist team of Pharmacovigilance experts, fully trained (and registered by the EMA) in the xEVMPD who can support your PV activities. We help you maintain the system in-line with changes to your MAs including variations, renewals, change of suppliers etc. We do this through our Flexible Resourcing Model to ensure a cost effective, efficient solution to help you better manage your in-house resource and budgets.
Woodley BioReg further offers full QPPV and PV services to its clients as part of its holistic service provider approach.
For more information are to discuss your requirements please contact us.
