16:57 22.11.2017

EBA notes lack of common understanding of drug quality control rules by territorial bodies of State Medicines Service

EBA notes lack of common understanding of drug quality control rules by territorial bodies of State Medicines Service

The European Business Association (EBA) has noted a lack of common understanding by the territorial bodies of the State Service of Ukraine on Medicines and Drugs Control of the rules of state control over the quality of medicines.

Executive Director of the EBA Health Care Committee Natalia Serhienko told Interfax-Ukraine there is a problem with the objective assessment by the territorial authorities of the medicines, which are imported to Ukraine in accordance with the established regulatory requirements.

"The same drug with the same package of documents, which the company provides to obtain conclusion on the quality, can be immediately released to the market by one territorial agency and simultaneously have a number of remark from another," she said.

Comments of the territorial bodies of the regulator are not accompanied by official letters and most often arise at the last stage of assessment of the package of documents of the importing company, according to which there appears a barrier to their access to final consumers as drugs are delayed in the warehouses without any justifications.

In her opinion, the comments of the department on the discrepancy of the quality certificate, which is adopted by the regulatory bodies of the countries of the European Union, indicate that "the country does not accept European practices on this part."

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