The European Medicines Agency has revised the rules on fees payable to the Agency. The revised rules, which came into force on 24 August 2012, now include clarification on:
- – the definitions of type-II quality variations, which now include references to non-clinical data for basic fees;
- – the mechanism for financial compensation for national competent authorities and inspectorates.
Further details are available in the explanatory note on fees payable to the Agency.