Registration with the Eudravigilance Post Authorisation Module (EVPM) Portal is now a mandatory requirement for all EU marketing authorisation holders. Red Line Pharmacovigilance is experienced in the use of Eudravigilance and our staff are fully compliant with Eudravigilance User Training requirements. The portal has a two facilities required by European marketing authorisation holders:
- Electronic Reporting of Suspect Adverse Reactions (E2B):
With effect from 20th November, 2005, the electronic reporting of suspected serious adverse reactions has become mandatory. Eudravigilance is a data processing network and management system for the reporting of suspected adverse reactions in the European Economic Area (EEA). Eudravigilance has become one of the main pillars of the European Risk Management Strategy and is a tool for the European Medicines Agency (EMA) and other regulatory authorities to monitor the safety of medicinal products and manage or minimise potential risks. The new regulations now require a 15 day deadline for the reporting of all serious adverse reactions and a 90 deadline for all non-serious adverse reactions. Failure to comply with this regulation constitutes a critical breach of pharmacovigilance regulations during any Pharmacovigilance inspection.
- Extended Eudravigilance Medicinal Product Dictionary (XEVMPD):
In December 2010, new pharmacovigilance legislation was adopted in the EU resulting in the need for marketing authorisation holders, human and veterinary, to update the Eudravigilance Medicinal Product Dictionary (EVMPD) with up to date information on all company product licences. Marketing authorisation holders are required to submit information on an ongoing basis, pertaining to new licence acquisitions, updates, approved variations or corrections to existing product information and details of product nullifications or the withdrawal of licences from the EU market. The new regulations now require a 15 day deadline for the submission of information to the XEVMPD. Failure to comply with this regulation constitutes a critical breach of pharmacovigilance regulations during any Pharmacovigilance inspection.
If you wish to discuss your Eudravigilance requirements and what we can do for you please click here.