FBiH entity rejects canton's request to import Sputnik V vaccine without testing

NEWS 13.02.2021 16:59
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Source: N1

The Health Ministry of Bosnia’s Federation (FBiH) entity rejected a request from the local public health institute in the West Herzegovina Canton (ZHK) to submit a letter of intent stating that it will procure 20,000 doses of the Sputnik V vaccine without additional testing and that all costs will be borne by the state in cooperation with a local distributor, N1 found out.

In its Friday letter to the Ministry, the ZHK institution said that “the Institute's efforts to advocate for the procurement of vaccines against the SARS-CoV-2 virus achieved a result” and that it received a “written guarantee for the delivery of 20,000 doses of Sputnik V vaccine from PPG Group Worldwide Switzerland, whose director is Dr. Nemanja Stoilovic.”

The ZHK institute asked the FBiH ministry to submit a letter of intent saying:

“We (the FBiH Ministry of Health) want to procure 20,000 Sputnik V vaccines for the West Herzegovina Canton, according to the emergency import regime. We would like to take this opportunity to inform you that the Sputnik V vaccine will be accepted on our market without additional tests and that all procurement costs will be borne by the state in cooperation with the distributor Hercegovinalijek doo, which is authorized to import and has all necessary permits and has adequate storage space according to all standards required for storage of the Sputnik V vaccine.”

The letter states that the letter should be submitted as soon as possible, preferably the same day, in two versions – in the English language and in Croatian.

“After receiving the documentation, PPG Group Worldwide will, in cooperation with the Russian Institute, the manufacturer and RDIF of the Russian Federation, provide all necessary and precise information regarding the procurement of Sputnik V vaccine,” the request said.

The FBiH Ministry, however, rejected it and pointed out that the emergency import of medical products is regulated in the law and in official guidelines.

The proper procedure is “known by all importers in BiH who apply to this Ministry for approval of emergency import of medicines,” it said.

“This ministry cannot even issue a letter of intent mentioned in the text you are requesting,” the response said, stressing that it was “inadmissible” for the ministry to have the letter say that it would accept vaccines for the BiH market without additional tests, “given that we are legally obliged to ensure the quality and safety of vaccines entering BiH.”

“Also, in the letter, you ask us to state that the procurement costs will be borne by the state, which this ministry has no legal competencies over at all,” it said.

“We warn that no risky drug, including vaccines, can be marketed and used without the previously obtained findings of the Control Laboratory of the Agency for Medicinal Products and Medical Devices of BiH,” the response, by Minister Vjekoslav Mandic, concluded.

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