Health Care

03/ 02/ 2021

Language requirements will be changed for the documents submitted for medicines quality certification

Starting from January 29, 2021, within 2 weeks, it is possible to submit documents for medicines quality certification in Russian translation with a letter that guarantees the subsequent obligation to translate those documents in the Ukrainian language.

Thus, the European Business Association is pleased to announce that this was achieved as a result of negotiations between the EBA Health Care Committee and representatives of the State Service of Ukraine for Medicines and Drug Control.

The change in the requirements for submitting quality certificates exclusively in Ukrainian was introduced by the State Service for Medicines without prior information and time for preparation of registration certificate holders, which could lead to the termination of supplies of quality and safe medicines to Ukraine.

The European Business Association thanks Irina Suvorova, Director of the Department of Quality Control of Drugs of the State Service for Medicines, for effective dialogue with representatives of the business community and settlement of the issue by providing registration certificate holders with extra time to prepare the documents in the state language. Thus, with joint efforts, we managed to prevent interruption of supplies of medicines.


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