All Marketing Authorisation Holders (MAHs) for any medicinal product authorised or registered within the EU and UK must submit information relating to the pharmacovigilance of their medicines; regardless of where the MAH is 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 throughout 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 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, and more. It is part of the ongoing MAH’s responsibility to ensure these details are updated through formal notifications.
The PV directive also requires the development and implantation of a compliant PV systems integrated into the GMP QMS and under the control and management of a QPPV (Qualified Person for Pharmacovigilance). Failure to comply with these mandatory safety requirements will result in product withdrawal and regulator action.
Need further information?
For many pharmaceutical and generic drug manufacturers who hold Mas, the requirements to complete xEVMPD present a problem in terms of knowledge as well as training in the use of the system, assigning the 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 can help you maintain the system in-line with changes to MAs including variations, renewals, change of suppliers and more. WBR provides a flexible resourcing model to ensure a cost effective and efficient solutions.
Woodley BioReg further offers full QPPV and PV services to its clients as part of our holistic service provider approach. WBR’s PV and QPPV services are fully compliant to EU requirements and include provision for:
- Case management (EVDAS, Translation, CIOMS, medical evaluation, data migration, etc.)
- Literature monitoring
- Documentation support and management (PV-QMS, SOPs, SDEA, PSURs, Core Safety Datasheets, etc.)
- Medical information
- Monthly reports, audits, and training