Pełne sprawozdanie z obrad

Środa, 16 kwietnia 2014 r. - Strasburg

14.8. Europejska Agencja Leków (nadzór nad bezpieczeństwem farmakoterapii w odniesieniu do produktów leczniczych stosowanych u ludzi) (A7-0476/2013 - Linda McAvan) (głosowanie)

Report: Linda McAvan (A7-0476/2013)

Commission Declaration

In the light of the decision of the Council to significantly decrease the fee income of the European Medicines Agency (EMA) from the fee for pharmacovigilance referrals referred to in Article 6 of the legal proposal on ‘Fees payable to the European Medicines Agency (EMA) for the conduct of pharmacovigilance activities in respect of medicinal products for human use’ (COM(2013) 472 final of 26.6.2013), the EMA will not be able to cover its estimated costs foreseen in the financial statement that accompanied the legal proposal. Therefore, the Commission, in cooperation with the EMA, will re-examine the activities performed and services provided by the EMA in this context, including payments to the delegates of the relevant committees, in order to achieve the necessary cost savings and cater for this estimated lack of revenue.

The Commission notes that the above mentioned Council position is without prejudice to the future review of the EMA fees.