Darnytsia Highlights Opportunities and Challenges for Ukrainian and Polish Pharmaceutical Companies Ahead of Ukraine’s EU Accession
Darnytsia Pharmaceutical Company participated in a roundtable discussion addressing opportunities and challenges for Ukrainian and Polish pharmaceutical companies in the context of Ukraine’s upcoming EU accession.
The event was organised by the European Office of the Union of Ukrainian Entrepreneurs (SUP) with the support of CIPE (Center for International Private Enterprise) and in partnership with the Polish law firm Rymarz Zdort Maruta.
During the roundtable, Anna Pavliuk-Havrylova, Head of the Department of International Registration and Market Expansion, noted that Poland’s pharmaceutical market is among the top five largest in the EU, while Ukraine leads in growth potential within Central and Eastern Europe. This, she emphasised, creates opportunities for Polish-Ukrainian collaboration in the pharmaceutical sector.
She outlined the key prerequisites for such collaboration and highlighted potential challenges that could impede effective cooperation.
A significant prerequisite for cooperation is expansion of Darnytsia, which is the leader of the national pharmaceutical production, to new markets, including those within the EU. In 2024 alone, Darnytsia entered six new markets and registered nine new medicinal products globally.
Since 2011, Ukraine has been a member of PIC/S (Pharmaceutical Inspection Co-operation Scheme), an international organisation comprising over 50 national regulatory authorities that oversee compliance with Good Manufacturing Practice (GMP) standards. The organisation aims to harmonise GMP standards and promote cooperation among inspection authorities across Europe, the USA, Canada, Australia, Japan, South Korea, India, Brazil, and some other countries in Asia, Latin America, and the Middle East. However, Anna Pavliuk-Havrylova pointed out that the current system operates in a one-sided manner, posing a significant challenge.
“Every time a medicinal product is registered in Ukraine, our regulator issues an opinion confirming that the manufacturing conditions comply with GMP requirements based on a specific set of documents. However, when we enter EU markets, our GMP certification is not recognised, requiring us to undergo GMP inspections. These inspections are not conducted for an entire product line but for each individual product, which is then reflected in the GMP certificate. Therefore, another potential area for progress towards EU accession could involve recognising GMP certificates not through individual inspections but through the audit of documents provided by the national regulator,” concluded Anna Pavliuk-Havrylova, Head of the Department of International Registration and Market Expansion.