EMEA: Rules for the implementation of Regulation (EC) No 297/95 as amended on fees payable to the European Medicines Agency and other measures


The rules apply to:

  • Scientific advice and protocol assistance
  • Scientific services
  • Extension of marketing authorisations
  • Type II variations
  • Annual fee
  • Administration services
  • Inspections
  • Scale of fees payable to national competent authorities

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