Making amendments to the registration of license

There can be necessity to make different amendments – from technical mistakes correction, that appeared in the process of registration, till making essential amendments during the period of validity of the registration certificate of a medical product. The range of amendments (influencing on quality, effectiveness, safety of a product) needs new registration.

Further amendments are divided into 2 categories – important and unimportant. The order of procedure, document package, terms of holding depend correspondently on the category and content of amendments.

Generally, the process of registration of amendments includes the following stages:

1st stage	Primary consultation of the client on procedure.
2nd stage	Pre-expertise of the clients’ document package.
3rd stage	Concordance of terms and conditions of the procedure for registration amendments.
4th stage	Execution/presentation of the offer for registration amendments to MH of Ukraine.
5th stage	Execution/presentation of micro file for medical product to SEC.
6th stage	Maintenance of state expertise of the file in the committees.
7th stage	Payment of bills (SEC expertise services+ governmental charge).
8th stage	Preparation for presentation/presentation of registration as a unit, corresponding to the specified expert committee.
9th stage	Maintenance of state expertise of the file in the committees. Development of expert’s remarks.
10th stage	Meeting at SEC on the matter of registration amendments.
11th stage	Receipt/reading of registration documents project.
12th stage	The order of MH on medical product registration.
13th stage	Receipt of the originals of registration documents.

Please, contact us, we’ll help you to conduct the procedure of registration amendments maximum effectively.