Apr 07, 2021

Ukrainian pharmaceutical manufacturers take a stand for mutual recognition of GMP certificates with EU

Володимир Костюк

On April 1, 2021, the Ukrainian Association of Business and Trade (UBTA) hosted a meeting of the domestic pharmaceutical industry representatives and public authorities. Deputy Minister for Economic Development, Trade and Agriculture – Trade Representative of Ukraine Taras Kachka, Deputy Minister of Health of Ukraine for European Integration Ihor Ivashchenko and representative of the State Service of Ukraine on Medicines and Drug Control, as well as the Senior Management of Farmak, Arterium, Biofarma, Indar, Omnifarma and Yuria-Pharm have attended this event.

 The meeting has been focused on forming a coalition of the domestic pharmaceutical industry representatives and discussing further common steps of the state and business to expand the access of Ukrainian medicines in the EU market. Non-recognition of GMP inspection results in Ukraine by the EU regulatory authorities is one of the main non-tariff barriers for Ukrainian pharmaceutical industry in trade with the EU.

Володимир Костюк

During his speech Volodymyr Kostiuk has noted that Farmak exports its products to 37 countries, including EU member states. However, double inspections which Ukrainian manufacturers are currently forced to undergo when exporting medicines to the EU require significant expenses and result in considerable increase in the cost of Ukrainian products. Mr. Kostiuk has also emphasized that the pharmaceutical businesses have chances to change a current status quo and use “window of opportunities” that is open for Ukrainian pharmaceutical industry only if they are united.

The event participants have proposed to start a dialogue about mutual recognition of GMP certificates and state inspections at the international level within updating of the Association Agreement between Ukraine and the EU. To extend the scope of the future Agreement on Conformity Assessment and Acceptance of Industrial Products (ACAA) with the EU to the pharmaceutical sector is considered as an alternative way (following the example of the same Agreement between Israel and the EU in 2013).


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