Timetable for Handling MAs and Variations
Timetable for handling applications
|
EU |
MR |
National |
Parallel import |
|
|
Application for Marketing Authorisation |
30 days after Commission Decision |
30 days after Mutual Recognition |
210 days |
120 days |
|
Variation type IA |
30 days (notification) |
14 days |
30 days |
30 days |
|
Variation type IB |
30 days after Commision Decision |
30 days |
60 days |
60 days |
|
Variation type II |
30 days after Commission Decision |
|
|
|
|
Variation type II – minor |
|
60 days |
60 days |
60 days |
|
Variation type II - major |
|
60 days |
90 days |
90 days |
_____________________________________________________________________
Other business
|
General issues |
14 days |
|
General issues regarding specific medicinal products |
60 days |
|
Samples of packaging |
60 days |
|
Samples of final patient information leaflets |
60 days |
