Table 4.
Survey results on marketing authorisation applications using MRP/DCP
Total | Procedures resulting in a MA | Procedures resulting in licensing failure | CMDh referral | |
---|---|---|---|---|
Completed in all Member States | 174 (84 %) | 156 (75 %) | 9 (4 %) | 9 (4 %) |
Withdrawn ≥ 1 Member Statesa | 20 (10 %) | 19 (9 %) | 0 | 1 (<1 %) |
Withdrawn in all Member States prior to CMDh referralb | 14 (7 %) | 0 | 14 (7 %) | 0 |
Total number of procedures | 208 (100 %) | 175 (84 %) | 23 (11 %) | 10 (5 %) |
aOutcome in remaining Member States
bIncluding the existing marketing authorisation in the RMS