European Medical Agency to increase fees upto 1.7 %

There would be an increase in fees upto 1.7 % from April 1^st 2018 as mentioned in the notification of Commission Regulation (EU) No 2018/471 (amending Council Regulation (EC) No 297/95), the fees however would be implemented for all activities carried out by the agency except pharmacovigilance. Apart from Pharmacovigilance the agency has also exempted fees ofMicro Small or Medium Sized Enterprise, Orphan Medicinal Products, Medicinal Products for Paediatric Use, Advanced Therapy Medicinal Productsetc… Detailed information on has been provided on an explanatory note.

The agency every year revises its fees as per the statistical data from EUROSTAT (European Union’s statistical office), the current revision is made in accordance with the inflation rate for 2017.

Reference:

1.       Explanatory note on general fees payable to the European Medicines Agency

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/03/WC500246428.pdf

2.       COMMISSION REGULATION (EU) 2018/471 of 21 March 2018

http://www.ema.europa.eu/docs/en_GB/document_library/Other/2018/03/WC500246427.pdf

Brought to you by:

Cliniminds (www.cliniminds.com),leader in Pharmacovigilance & Clinical research training and consulting 

Clinimindsoffers ‘Hands On’ training case processing on ORACLE Argus Safety and other safety databases. Our students are entitled for free DIA membership.