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 […]
About Dr. Jeanette Haney
This author has yet to write their bio.Meanwhile lets just say that we are proud Dr. Jeanette Haney contributed a whooping 13 entries.
Entries by Dr. Jeanette Haney
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) […]