Entries by Dr. Jeanette Haney

The truth serum for PV systems in Germany Survey helps BfArM to plan PV inspection priorities Monday, 20th January 2020 14:43 MET: EU-QPPVs and Stufenplanbeauftragte of pharmaceutical companies holding Marketing Authorisations in Germany receive an email. Sent from BfArM and PEI. Subject: Questionnaire for risk-based PV inspections What had happened? BfArM (Federal Institute for Drugs […]

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) […]