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.
The types of variations are classified as follows:
- minor IA variations where immediate notification is needed;
- minor IA variations where no immediate notification is needed;
- minor IB variations;
- major II variations.
|
Type |
Duration of the validation period |
Duration of the procedure (assessment) |
Date of implementation |
|
IA |
– |
30 days |
date stated by the applicant* |
|
IA IN |
- |
30 days |
date of submission** |
|
IB |
7 days |
30 days |
31. day of the procedure |
|
II |
14 days |
30 days 60 days 90 days |
with the date of issuing the decision |
|
Directive 2001/83 61(3) |
– |
90 days |
91. day of the procedure |
|
INCLUDE/EXCLUDE PACK SIZES IN THE HUNGARIAN MARKETING AUTHORISATION WITHIN THE VALUES APPROVED IN MRP/DCP |
– |
8 days |
with the date of issuing the decision |
|
COMBINATION OF THE REGISTRATION NUMBERS (global MA) |
– |
8 days |
with the date of issuing the decision |
|
CHANGE IN THE LEGAL STATUS OF THE PRODUCT |
– |
8 days |
with the date of issuing the decision |
* In case there is no date stated in the Application Form, the 31. day of the procedure will be put on the product information
** submission date = day0
