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.

 

Posted on the EMA website on 12 Sep 2012