Entries by Dr. Jeanette Haney

EudraVigilance fees

To finance the cost of pharmacovigilance activities of the European Medicines Agency (EMA), the Fee Regulation (EU) no. 658/2014 has been introduced. In her “Explanatory Note” published on March 11th 2015 the EMA defines different fees such as process-based and annual fees. This is based on “chargable units” for MAHs, which in future can be […]

XEVMPD – Frequently Asked Questions

Which medicinal products fall within the scope of Article 57 (2) and need to be reported in xEVMPD ? All medicine products authorized in the EU (national authorizations, MRP, DCP, CP) must be reported via an Extended EudraVigilance Product Report Message (xEVPRM). Registrations in EEA countries not belonging to the EU (Iceland, Liechtenstein and Norway) […]