Ukrainian and Polish pharmaceutical companies proposed simplifying the certification system and agreeing on mutual recognition of product certificates in both countries and at the EU level. Such reforms would allow businesses to operate competitively without unnecessary bureaucratic barriers. The Union of Ukrainian Entrepreneurs (SUP) actively advocates for reducing regulatory burdens on businesses.
Key Discussions and Challenges
The event, organized by SUP’s European Office, gathered representatives from leading pharmaceutical companies (including SUP members Farmak and Darnytsia), legal experts, and industry specialists. Participants discussed opportunities and challenges faced by Ukrainian and Polish pharmaceutical companies, particularly as Ukraine prepares for EU membership.
Double Certification
Viktoriya Popovych, manager at the Ukrainian pharmaceutical company Farmak, highlighted that one of the main challenges for Ukrainian producers is the lack of recognition of Ukraine’s Good Manufacturing Practice (GMP) certificates by EU regulators. This forces companies to undergo double certification—first in Ukraine and then in the EU. Additionally, they must comply with the *batch release* procedure, requiring every batch of medicines to be tested before being released to the European market.
“These are real barriers that place Ukrainian companies at a disadvantage compared to their European competitors. We lose competitiveness due to additional costs and delays in market access,” said Viktoriya Popovych.
Farmak operates two production facilities in Ukraine, a factory in Spain, and has offices and distributors in countries such as Poland, the Czech Republic, Slovakia, the UK, and the UAE. It exports to 60 countries, including 15 EU nations, but must prove its product quality twice.
“The introduction of a mutual recognition mechanism for GMP certificates is critical for large pharmaceutical companies, which have much to offer to European consumers. Importantly, this solution would benefit not only Ukrainian manufacturers but also our European partners, including Polish pharmaceutical companies operating in Ukraine,” she added.
Market Opportunities
Anna Pavliuk-Havrylova, Director of Global Regulatory Affairs and Market Access at Darnytsia, emphasized that Poland is one of the EU’s top five pharmaceutical markets, while Ukraine’s market is growing rapidly, creating opportunities for cooperation. She noted that Darnitsa has recently entered six new markets and registered nine new medicines.
Touching on the issue of certification recognition, Pavliuk-Havrylova reminded the audience that Ukraine is a member of PIC/S (Pharmaceutical Inspection Co-operation Scheme), an international organization that includes regulatory authorities from over 50 countries.
“Unfortunately, this system currently operates in a one-sided manner. When registering medicines in Ukraine, our regulator issues the relevant certificates. However, when entering EU markets, our GMP is not recognized, and we must undergo inspections. This process is conducted not for an entire production line but for each individual product, which is reflected in the GMP certificate. Another potential pathway for reform could be the recognition of our GMP certificates through document audits conducted by national regulators rather than physical inspections,” she explained.
Polish Perspective
Polish pharmaceutical companies also face challenges. Alena Krzhyzaniak, Export Specialist at Poland’s Biofarm, noted that Poland encounters logistical difficulties when exporting to Ukraine, particularly amid the ongoing war.
“Our industry is highly regulated, and it’s essential to resolve these issues and create equal competitive conditions. I understand the difficulties faced by Ukrainian companies because Polish producers encounter similar challenges when operating in non-European markets. Even within the EU, not all countries treat foreign producers equally,” Krzhyzaniak said.
Legal and Political Proposals
Tomasz Kaczyński, Partner at Rymarz Zdort Maruta, suggested that Ukrainian and Polish business associations collaborate to develop simplified procedures for certificate recognition.
“This can be addressed during Ukraine’s EU accession negotiations, which provide room for transitional measures to adapt Ukraine’s standards to EU requirements. By raising such issues during EU-Ukraine discussions, we can incorporate them into accession documentation,” he explained.
SUP’s Commitment
SUP Executive Director Kateryna Glazkova concluded the discussion, pledging that SUP would work with Polish partners to develop practical solutions.
“We will not stop at this discussion but will analyze how we can move forward with our Polish partners, including the Confederacja Lewiatan and market participants. Ukraine already has national negotiation groups for EU accession, with SUP representatives included in each cluster. This allows us to raise issues like certification recognition at the EU-Ukraine negotiation table,” said Glazkova.
Background on GMP
GMP certification ensures compliance with international standards for the production of medicines, covering personnel, equipment, facilities, storage, labeling, and distribution requirements. In Ukraine, GMP certification is conducted by the State Service of Ukraine on Medicines and Drug Control.
About SUP
SUP is Ukraine’s largest business association, uniting over 1,200 companies from small, medium, and large enterprises, independent of oligarchic or state influence. Its mission is to foster a favorable business climate in Ukraine and beyond. Both Farmak and Darnytsia are members of SUP.
The event was supported by CIPE Ukraine and organized in partnership with the law firm Rymarz Zdort Maruta.