EMEA Fee Structure Proposals

Although the European Parliament does not meet until this week (January 16-21) for its plenary session, where it will discuss the Council of Ministers of the European Commission's proposed structure of fees for drug approval applications to the European Medicines Evaluation Agency (Marketletter January 9), it is understood that the main features of this fee structure are as follows:

Centralized Procedure ECU Standard fee: This fee will be incr- 140,000 eased by 20,000 Ecu for each additio- nal dosage form and/or pharmaceutical form of the same medicine introduced at the same time as the first application request, with a ceiling of 200,000 Ecu. Reduced fee: for applications not sus- 70,000 tained by a full dossier. This fee will be increased by 10,000 Ecu for each additional dosage and/or pharmaceuti- cal form of the same medicine introd- uced at the same time as the first appli- cation request, with a ceiling of 100,000 Ecu. Additional fee for applications in 40,000 stages: This fee applies for each add- itional application concerning an exis- ting Community marketing authoriza- tion for different strengths, schedules of dosage, routes and forms of admin- istration, where an applicant chooses to submit the application after intro- ducing the first application. Administrative variations of Type I 5,000 (minor variations) Type II variations 40,000 Five-yearly renewals 40,000 Inspections 10,000 Transfer fees: 5,000 Decentralized Procedure Arbitration: 30,000 Ecu = $1.23560

The setting of the arbitration fee at 30,000 Ecu (which is 10,000 Ecu less than the original proposal) is seen as an important feature of the proposed fee structure.