Balkan Pharmaceuticals manager responds to MP Brega's statements

The local manufacturing company Balkan Pharmaceuticals operates in correspondence with the law and observes all the requirements imposed on pharmaceutical producers. This is how the company's general manager Silviu Chiru responded to the statements made by MP Gheorghe Brega about irregularities discovered at the company by the Parliamentary Inquiry Commission on the Pharmaceutical Market, which he heads. As concerns the statement that Balkan Pharmaceuticals has obtained in recent years authorizations for 167 forms of drugs, whereas other manufacturers have only 1 or 2 such authorizations, and this is despite the fact that it takes up to 8 months to obtain one such certificate, Silviu Chiru said that it is important to see how many applications for such certificates those manufactures submitted. “The fact that some companies obtained registration certificates just for one ore two drugs speaks only about the lack of applications from them”, explained Chiru. “In the case of a drug produced by Balkan Pharmaceuticals which was invented and made available a long time ago, the assertion that this drug was registered within two months is only partially true, because the term of two months is only administrative, during which the relevant authorities must make a pronouncement on the completeness of the documents annexed to the application. Prior to receiving an authorization, the applicant undergoes a lengthy and tiresome procedure of collecting the necessary documents, which may take several years, and which includes quality control of the product to be registered”, said Silviu Chiru. Concerning the statement that the Inquiry Commission found the company's spaces inadequate for such sort of business, Sliviu Chiru said that the company has all the necessary certificates from the relevant authorities. “The Licensing Chamber issued us a license and each our product has a production authorization issued by the Medicines Agency”, said Chiru. Silviu Chiru added that the inspections initiated by the Inquiry Commission affected their reputation – despite not being able to reveal any violations – for which Balkan Pharmaceuticals will seek damages in court.