The Ministry of Health promised to allow a one-time import of kanamycin and capreomycin in Ukraine
The Ministry of Health of Ukraine guarantees the granting of permission for the one-time import in Ukraine of the TB second-line drugs - kanamycin and capreomycin that meet the international quality standards (WHO prequalification, GMP – “Good manufactures practice”), but don’t have the registration certificate of the Ministry of Health of Ukraine. The purchased drugs are needed for treatment of 560 patients with MDR TB within the framework of “Stop TB in Ukraine” Program of the Global Fund to Fight AIDS, Tuberculosis and Malaria.
This is stated in the Letter of the Ministry of Health of January 12, 2012, in response to the appeal of Tatyana Bilyk – Leader of the “Stop TB in Ukraine” Program with the financial support of the Global Fund to Fight AIDS, Tuberculosis and Malaria of the Rinat Akhmetov’s Foundation for Development of Ukraine.
“The Ministry of Health of Ukraine guarantees to approve the obtaining of a permit for the one-time import of the unregistered anti-TB drugs kanamycin (manufacturer Meiji, Japan) and capreomycin (manufacturer Akorn, USA) for the treatment of 560 patients under the Project of the Global Fund to Fight AIDS, Tuberculosis and Malaria” - says the letter signed by the Deputy Minister of Health Tolstanov K.
Under the rules of the Ministry of Health, for obtaining the permission to import the unregistered drugs it is necessary to provide the information on compliance with international standards of the quality of drugs, their name, manufacturer, presentation, dosage, number of packages, batch number and expiration date. However, the purchase of anti-TB drugs under the Global Fund Project shall be conducted through the Global Drug Facility (GDF), which orders the drugs from manufacturers only after the registration of the application for the purchase, conclusion of the contract and fulfillment by the customer (the ICF “International HIV/AIDS Alliance in Ukraine”) of the financial liabilities. Thus, the information on the batch number of kanamycin and capreomycin shall be available only after the implementation of the above procedures.
As noted in the Letter of the Ministry of Health, the guarantee shall be provided taking into account the fact that the manufacturers will provide the information the Ministry of Health needs to issue an application for the one-time import of the unregistered drugs kanamycin and capreomycin only after the fulfillment by the ICF “International HIV/AIDS in Ukraine” of financial obligations to the Global Drug Facility (GDF).