European Medicines Agency clarifies rules on fees

News 12/09/2012

The European Medicines Agency has revised the PDF icon 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 PDF icon explanatory note on fees payable to the Agency .

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