The Commission presents a communication aiming to update the financial statement accompanying Regulation (EC) n° 297/95 in order to reflect the actual staffing needs of the European Medicines Agency.

The European Medicines Agency was set up by Regulation (EC) No 726/2004 of the European Parliament and of the Council. This Regulation establishes that the revenue of the Agency shall consist of a contribution from the European Union, and the fees paid by the undertaking for obtaining and maintaining a Community marketing authorisation and for other services provided by the Agency.

Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency sets out the different types of fees payable for services provided, including the possibility for waivers and reductions of certain fees. The corresponding financial statements (if applicable) for Regulation (EC) No 297/95 and its amendments in 19984, 20035 and 2005 did not provide for the human resources required to handle fee-related applications.

The Budgetary Authority agreed to additional staff for fee-related activities in 2010. For 2011 and 2012 no additional fee-financed staffing was provided; the additional posts agreed for 2012 correspond to the implementation of the new pharmacovigilance activities only.

In the draft budget for 2013, the Commission agreed on an increase of the Agency’s establishment plan with 21 additional posts, to be financed by fees from the industry . With this Communication, the Commission presents the factors that justify this increase, these being:

· the fee-related activities of EMA have developed substantially since 2010, entailing an expansion of workload for the Agency, yet with no corresponding increase in staff;

· at the same time, the fee-related income of the Agency, based on recovery orders/invoices sent, increased from EUR 171,9 million in 2010 to EUR 179,8 million in 2011 and is estimated to increase further to EUR 200.8 million in 2013. This corresponds to a 5.9% increase for the period 2010-12 and a 16.8% increase over the period 2010-13, which translates into the corresponding increase in workload.

These recent developments in fee-related activities are of a long-term nature and the Agency requires 21 additional temporary agents as of 2013. The initial financial statement should therefore be revised to adapt to the reality of the agency's staffing needs. The extra staff will be funded by the fee income generated through these activities and is therefore neutral for the EU budget.

The Commission emphasises that the current fee-financed increase in staffing is not linked to the implementation of the new pharmacovigilance legislation , applicable as of July 2012.

OBJECTIVE : Council Regulation (EC) No 297/95 lays down the structure and the amount of fees paid by undertakings for the examination and revision of Community authorizations to market medicinal products and other services provided by the European Agency for the Evaluation of Medicinal Products. SUBSTANCE : Undertakings have to pay a basic Community fee of ECU 140,000 for medicinal products for human use, and ECU 70,000 for veterinary medicinal products, with a view to obtaining an authorization to market the said products as required by the centralized procedure. The Regulation also provides for a number of other fees as follows: - a reduced fee for applications which do not have to be supported by a full dossier (ECU 70,000 for products for human use; ECU 35,000 for veterinary products); - an extension fee when the applicant wishes to extend the applications made for the same medicinal product (ECU 40,000 for products intended for human use; ECU 20,000 for veterinary products); -a variation fee for minor administrative modifications of type I, which is fixed at ECU 5,000, and a variation fee for complex modifications of type II, which is fixed at ECU 40,000 for medicinal products for human use and at ECU 20,000 for veterinary products; - a renewal fee which is charged for the obligatory five-yearly renewal of the Community marketing authorization (ECU 10,000 for products for human use; ECU 5,000 for veterinary products); - a flat-rate fee of ECU 10,000 for inspections which are undertaken subsequent to the issuing of a marketing authorization, at the request of, or in the interest of, its holder; - a fee which is charged for the Agency's arbitration services in the event of disagreement between Member States as to the authorization of a medicinal product in accordance with the decentralized procedure (ECU 30,000 for medicinal products for human use; ECU 15,000 for veterinary products). In exceptional circumstances, and for imperative reasons of public or animal health, waivers and fee reductions may be granted on a case by case basis. The Agency shall indicate in its annual estimate intended for the establishment of the preliminary draft budget of the Commission the estimates concerning revenues obtained from fees for the following financial year. Date of entry into force of the Regulation: 16.02.1995.