The European Medicines Agency (EMA) released the updated version of the Explanatory note on general fees payable to the European Medicines Agency in July 2021.

The changes introduced in this version are mainly clarifications of:

  • The ‘change in the details of a parallel distributor’
  • The date of invoicing for inspections
  • which legal entity fees can be charged

It should be considered that this document is intended to be a guidance only. In fact, the EMA clarifies that, in case of discrepancies between the explanatory note and the provisions of the Council Regulation (EC) No 297/95, the latter document prevails.

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