Inflation Drives Up Cost of EU Inspections
This article was originally published in The Gold Sheet
Executive Summary
Effective immediately, the European Commission March 27 increased the rate it charges for inspections to 18,200 Euros, or nearly $28,600 at the current exchange rate. Applicants for EU marketing authorization must pay the fee to the scientific committee that requested the inspection - either the one for human drugs or the one for veterinary drugs. The committees request pre-approval inspections and also can request post-authorization inspections. For inspections of facilities outside the European Community, the applicant also must pay travel expenses