Registration with the Eudravigilance Post Authorisation Module (EVPM) Portal is now a mandatory requirement for all EU marketing authorisation holders and with the MHRA E-Submissions Portal for UK marketing authorisation holders.
Let us manage your registration with regulatory portals, such as Eudravigilance, and handle your reporting of company adverse events. We can also maintain your company product licences on the regulatory portals, such as the Article 57 Database or XEVMPD system.
Regulatory portals have two functional areas:
1. Electronic Reporting of Suspect Adverse Reactions (E2B):
The electronic reporting of suspected serious adverse reactions has become mandatory. Regulations 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.
2. Extended Eudravigilance Medicinal Product Dictionary (XEVMPD):
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 market. Regulations have stipulated deadlines for the submission of information to the these portals and failure to comply with this regulation constitutes a critical breach of pharmacovigilance regulations during any Pharmacovigilance inspection.