Marketing authorisations  

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December 31, 2008
Number of authorised medicinal products (incl. all formulations and strengths)3278
In 2008
Number of initial applications received723
Number of marketing authorisations granted450
Number of applications for renewal of marketing authorisations603
Number of marketing authorisations renewed379
Number of applications withdrawn during the evaluation time and rejected applications
(incl. variations)
380
Number of applications for variations (type I and type II) to authorised products9195
Number of approved variations6757
Acting as a reference member state:
Number of procedures2 CP co-rap
6 DCP
2 RUP
Number of finalised procedures and variations5 DCP
I type variation – 13
II type variations - 5
MRP - Mutual Recognition Procedure
DCP - Decentralised Procedure
RUP - Repeat Use Procedure
CP – Centralized Procedure