In relation to the withdrawal of the BCG vaccine produced by the Institute of Virology, Vaccines and Serums “Torlak”, Republic of Serbia, from the market of Montenegro, the Institute for Medicines and Medical Devices would like to inform the expert and general public on the following:
In January of this year, the Institute for Medicines and Medical Devices, in accordance with the Law on Medicines, approved the import of this vaccine through the so-called emergency import, based on the assessment of submitted documentation which proved that the vaccine met the prescribed standards in terms of quality, safety and efficacy. The aforementioned documentation, among other things, includes two quality control certificates – Certificate of Analysis of the manufacturer of the medicine and the Certificate of Analysis issued by the National Control Laboratory of the Agency for Medicines and Medical Devices of Serbia, which is a member of the European Network of Official Medicines Control Laboratories.
Subsequent routine control carried out by the manufacturer determined that there was a possibility of a potential deviation of the number of live, attenuated Bacillus Calmette-Guerin (Mycobacterium bovis BCG) bacteria, compared to the number that had been declared. Therefore, expected immune response might be incomplete in an extremely small number of patients (newborns, children and adults at an increased risk for developing a tuberculosis). Due to this matter, mentioned batch of the vaccine has been withdrawn, bearing in mind that the manufacturer is obliged to withdraw a medicine from the market, even though a suspected defect that cannot cause serious consequences for human health is in question.