Agency for Medicines must also control vaccines from emergency import

(Patria) - The BiH Agency for Medicines and Medical Devices clarified back in the summer of 2019 that vaccines can enter BiH in two ways - based on a decision from the entity ministry responsible for health affairs or based on an import permit issued by this agency. 

"If a vaccine has not been granted a marketing authorization, then it is declared an unregistered medicinal product and can enter BiH through emergency import, i.e., based on a decision from the entity ministry responsible for health affairs," the Agency states. 

The procedure for registration and approval of a medicinal product, in this case a vaccine, is initiated at the request of the manufacturer or its legal representative based in BiH.

On the other hand, if this agency approves the vaccine and issues a permit for its marketing, i.e., registers the vaccine, then it also issues a permit for its import.

However, in both cases, whether the agency issues an import permit or the entity ministries import the vaccine, the BiH Agency for Medicines has the authority to perform quality control of the imported vaccine, with the possibility of engaging another laboratory to conduct specific tests.

"The assessment of efficacy and safety is done during the process of issuing a marketing authorization and is done at the request of the manufacturer or its legal representative based in BiH, as already stated."

We remind you that yesterday, Johan Sattler, EU Ambassador to BiH, and Minister of Civil Affairs Ankica Gudeljević discussed the procurement of vaccines for the residents of BiH. Gudeljević asked Ambassador Sattler to use his authority in the EU to speed up the process of delivering vaccines to BiH, which the ambassador confirmed, emphasizing that numerous European countries are facing the same issues and problems.

On the other hand, the BiH entity of RS announced that the Russian Sputnik V vaccine against COVID-19 will arrive in Republika Srpska as early as the end of February.

This was announced by the director of the Institute of Public Health of RS, Branislav Zeljković. He noted that the procurement of vaccines for the entire BiH is underway through the COVAX mechanism.

Zeljković also said that he is not informed about the progress of vaccine procurement for the Federation or for BiH through the COVAX mechanism.