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MAGYAR

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.

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

 

 

Additional information to the submission of variations

Last updated: 2017.10.18 11:09