Mutual recognition of GMP certificates will allow Ukrainian pharmaceutical manufacturers to intensify exports to the EU market with fewer regulatory barriers, domestic companies have fulfilled all the conditions set, according to pharmaceutical market participants interviewed by the Interfax-Ukraine agency.

“We will be very happy when mutual recognition of GMP certificates becomes possible, but for now we cannot even talk approximately about any specific dates or prospects. This issue is on the side of the state and EU regulatory authorities,” noted Acino Group pharmaceutical company.

At the same time, its experts emphasized that Acino has had a European GMP certificate for many years, and it does not have data on violations of standards by other companies, since such information is not publicly available.

“We have already passed and are regularly undergoing inspections by regulatory authorities to comply with GMP requirements. If there is mutual recognition of GMP certificates, companies will be able to export their products to the EU market with fewer regulatory barriers,” experts noted.

At the same time, commenting on the prospects for connecting Ukrainian pharmaceuticals to the European hub for drug verification, the company noted that, as a manufacturer, Acino Group is interested in creating such an opportunity as quickly as possible.

“We are already exporting medicines from our PharmaStart plant to seven countries. We can say that this has an extremely positive effect on the domestic market. Acino in Ukraine receives an additional source of income in order to invest in production,” the company clarified.

It is indicated that for the nine months of 2023, ACINO Ukraine LLC paid about UAH 800 million in taxes, and the company’s investments in the plant amounted to about EUR24 million since its acquisition in 2015.

For her part, Oleksandra Dmitriyeva, head of the department for government relations and social partnership of the pharmaceutical company Farmak, noted that in the context of global instability in the supply of both active pharmaceutical ingredients (APIs) and finished medicines on the part of European partners, there is a certain reassessment of the implementation of pharmaceutical visa-free regime with Ukraine.