Dialogue with the Ukrainian Pharmaceutical Business on Harmonisation with EU Requirements

On 14 January 2026, a meeting was held within the framework of the EU–UA Twinning Project “Support to the Establishment of the State Control Authority for Medicines and Medical Devices.” The event brought together EU experts, representatives of Ukrainian pharmaceutical companies, and national regulatory authorities.

Focus: harmonisation of Ukrainian legislation and marketing authorisation procedures with EU requirements. The discussion centred on bioequivalence, transitional provisions, and the implementation of the medicines verification system.

Harmonisation of National Legislation with EU Requirements

Participants thoroughly reviewed the timelines for bringing registration dossiers into compliance with the Law of Ukraine “On Medicinal Products” and Directive 2001/83/EC.

The EU side shared the Lithuanian experience: during EU accession, transitional periods allowed companies to continue operations while gradually aligning their documentation with EU requirements. Particular attention was given to Module 3 (Quality) and the importance of proper documentation to ensure future regulatory compliance.

Representatives of Ukrainian companies emphasised the need for:

• clear criteria for bioequivalence,

• a risk-based phased approach,

• investment planning to ensure uninterrupted access to medicines.

Additional costs were also highlighted, including those related to D2 coding, upgrading equipment and software, and compliance with price regulation requirements.

Draft Procedures and Transitional Period

The Ministry of Health of Ukraine confirmed that draft procedures for aligning dossiers with EU requirements will be developed, taking into account feedback from the business community.

The proposed next steps include:

• following preparation, national associations will submit proposals within one month,

• manufacturers will share information on their product portfolios.

It was also proposed to establish a working group involving regulators and manufacturers to address transitional exemptions and the review of bioequivalence.

Export and Access to the EU Market

A separate part of the discussion focused on the supply of critical medicinal products and participation in EU procurement procedures.

Participants underlined the importance of price and quality criteria, as well as investment readiness. At the same time, the need to apply EU procurement principles to candidate countries, including Ukraine, was emphasised.

Next Steps

• State Expert Center (SEC): prepare draft procedures for dossier harmonisation within several months.

• National associations: submit proposals to the SEC within one month.

• Manufacturers: share information on product portfolios for harmonisation.

• Working group: consider establishing an expert group on transitional exemptions and bioequivalence review.

• Continuation of dialogue: ensure regular communication between regulators and business; share Lithuanian experience.