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Ukrainian pharmaceutical manufacturers are striving to fully enter the European pharmaceutical market. At the same time, the European Union, which faced a crisis in the supply of basic drugs and ingredients from India and China during the COVID-19 pandemic, decided to revise its pharmaceutical policy and localize the supply and production of medicines closer to home. Ukraine can become such a strategic hub for medicines, as it is not only geographically attractive in this regard, but also has the status of an EU candidate state since June last year.

“One of the priorities of the European integration vector of the Ministry of Health is the pharmaceutical sector. In terms of legislative regulation, we meet the European requirements, but there is still work to be done in terms of procedures. First of all, we are talking about the creation of a single regulatory authority in the field of circulation of medicines and medical devices,” said Maryna Slobodnichenko, Deputy Minister for European Integration, during a panel discussion at the PharmaExport conference.

According to her, the Ministry of Health has already begun work on its creation and plans to launch the new body in 2025. The main purpose of its creation is to unify the procedures for the registration and control of medicines and medical devices with those in the EU.

In addition, to expand the export potential of the pharmaceutical industry, the Ministry of Health continues to engage in a dialogue with the European Commission in several areas:

• recognition of Ukrainian GMP certificates in the EU;
• inclusion of Ukraine in the centralized European procedures for the registration of medicinal products even before joining the EU;
• connection to the all-European system of verification of medicines (introduction of 2D coding and labeling system). 

“The Ukrainian pharmaceutical sector is quite powerful and resilient. Thanks to the domestic production of medicines, we did not face a shortage of medicines at the beginning of the full-scale invasion: despite the fact that your warehouses were destroyed and some of your employees left, you continued production. It is the pharmaceutical industry that is currently one of the readiest industries to enter the EU market. And it is very important for the country because the development of exports of Ukrainian pharmaceutical products can provide a steady income to the state budget, which is very important for post-war recovery. The Ministry of Health is ready to facilitate and support the development of the pharmaceutical industry in every possible way and remove all export obstacles within its powers,” said Maryna Slobodnichenko.

The regulatory procedures, which currently make it very difficult for Ukrainian pharmaceutical products to enter the EU market, can be significantly simplified by extending the ACAA (Agreement on conformity assessment and Acceptance of industrial products) to the pharmaceutical sector. According to Taras Kachka, Deputy Minister of Economy and Trade Representative of Ukraine, there are positive developments in this direction:

“We have been working with the European Commission for a long time, at least two or even more years, to change the emphasis in the context of the pharmaceutical market. For quite a long time, our formal proposal to include pharmaceutical products in the ACAA dialogue faced restrictions from the EU. Today, there is an understanding, and the emphasis has changed quite a bit: we understand that the road to a particular format of mutual recognition of pharmaceutical products is politically open, and now the question is how to implement it in practice. The starting point for us will be to update Annex III of the Association Agreement with the EU. This is in the plans for this year.”

For their part, representatives of the pharmaceutical industry urged their colleagues to step up their efforts to prepare for full entry into the EU market, including increasing investments in development and technology and joining European and international business communities.