If the media hadn't uncovered the vaccine affair, everything would have been hushed up!

The text about a certain chaos reigning in the Agency for Medicines and Medical Devices is confirmed by the response that the news agency Patria received from „Melcom“, the supplier of the anti-tetanus vaccine that caused side effects in several students in Sarajevo, reports the news agency Patria.

It is now clear that the Rulebook on the method of reporting, collecting and monitoring adverse drug reactions exists only on paper, and its implementation is directly under the authority of the Agency for Medicines, headed by Nataša Grubiša, the director whose mandate expired two years ago!.

Marko Nikolić from "Melcom", the person responsible for placing the drug on the market, told Patria that the system of reporting observed side effects by healthcare professionals and patients in BiH is regulated by the Rulebook on the method of reporting, collecting and monitoring adverse drug reactions.

- In accordance with the provisions, "Melcom" has established its own operational procedure for handling side effect reports. We have not yet received a notification about side effects in accordance with the Rulebook – said Nikolić.

To make matters worse, when asked about their information regarding this case, Nikolić replied that, following media reports, "Melcom" forwarded the notification about side effects to the manufacturer, Imunološki zavod d.d. Zagreb.

- We expect official notifications and possible vaccine samples used for vaccinations, which we would send for analysis. "Melcom" d.o.o. Mostar has suspended further sale of the vaccine from its warehouse and informed customers not to put any remaining vaccine quantities into circulation until final data on the vaccine's quality is obtained – added Nikolić.

He further explains that this is the first case of side effects occurring with this vaccine in Bosnia and Herzegovina.

-Last year, "Melcom" d.o.o. Mostar, in accordance with the provisions of the aforementioned Rulebook, submitted to the Agency for Medicines the PSUR 2010-2013 (periodic safety update report on reported side effects and events with the drug) from the manufacturer Imunološki zavod d.d. Zagreb. It stated that during that period, in all countries where it was used, not a single side effect was recorded during the administration of the drug Tetanus Vaccine, adsorbed – added Nikolić.