Variation procedure flow chart
Variation of a marketing authorisation means that there has been a modification which is being applied for concerning the documentation valid for the medicinal product.
Type IA and Type IB „minor” variations: listed in the Annex I. of decree 1084/2003/EC, and are suitable with the conditions defined there.
Type II „major” variation: the variation cannot be defined as a „minor” modification according to the Annex I. of decree 1084/2003/EC or as an extension of the marketing authorisation.
Types and deadlines:
|
Type |
Validation period |
Arrangement time |
Mode of action |
|
IA |
- |
14 days* |
Notification |
|
IB |
14 days ** |
30 days |
Notification |
|
II |
14 days ** |
30 days |
Decision |
|
Directive 2001/83 §61 (3) |
- |
90 days |
Notification |
|
Changing the MAH |
- |
30 days |
Decision |
* In case of a Type IA variation the National Institute of Pharmacy will – according to the decree 1084/2003 - acknowledge day0 of the procedure, and if the documentation is not appropriate the application will be refused within 14 days in a decision.
