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News about GMP/cGMP

EMA: New fees for marketing authorisation applications

The European Medicines Agency (EMA) has changed its rules on fees payable to the Agency. The new fee rules came into operation on October, 7 2010.

 

The revised rules include new, reduced fees for the third and subsequent type-II variations in a grouping or worksharing application, and for additional strengths or potencies of the same pharmaceutical form in an application for an extension of marketing authorisation.
They also include amendments to the fees for grouped variations to plasma and vaccine antigen master files, and to annual fees.

Outcome:

The new fees can be found here:

EMA also published two additional documents related to the new fees:

Sources:

EMA/ Announcement

EMA/ Fees for medicinal products for human use

EMA/ Fees for medicinal products for veterinary use and maximum residue limits

EMA/ Explanatory note on fees payable to the European Medicines Agency

EMA/ Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures

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