Requirements for medicinal product registration dossiers in line with EU standards

On 20 February 2026, an online meeting for external stakeholders was held within the EU–Ukraine Twinning Project “Support to the establishment of a medicines and medical devices regulatory authority in Ukraine.” The meeting focused on requirements for marketing authorisation dossiers in the context of Ukraine’s future accession to the European Union.

The event brought together representatives of the Ministry of Health of Ukraine, Lithuanian regulatory experts, pharmaceutical companies, marketing authorisation holders (MAHs), and specialists from the State Expert Center of the Ministry of Health of Ukraine.

Participants included Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, Lyubomyr Pytel, Advisor to the Deputy Minister, Lina Seibokiene, Resident Twinning Adviser from the Lithuanian State Medicines Control Agency, and Kristina Povilaitienė, Advisor to the Pharmaceutical Policy Department of the Ministry of Health of Lithuania and former Head of the Marketing Authorisation Department of the State Medicines Control Agency.

The meeting gathered more than 120 online participants, demonstrating strong interest from the pharmaceutical sector in upcoming regulatory changes linked to Ukraine’s European integration.

EU marketing authorisation procedures

During the meeting, the Lithuanian experience of transitioning to the EU regulatory system and adapting national marketing authorisation dossiers to EU legislation was presented.

The expert emphasised that integration into the EU regulatory framework provides access to the Single Market while ensuring a uniform level of public health protection across Member States.

A key principle was highlighted: if a medicinal product cannot be authorised through the Mutual Recognition Procedure (MRP) or the Decentralised Procedure (DCP), it should not be authorised through a purely national procedure.

Marketing authorisation holders were therefore encouraged to review their product portfolios to assess the readiness of their documentation for EU requirements.

Inventory of the national medicines register

The Lithuanian approach to reviewing the national register of medicinal products during the pre-accession period was also presented.

The process included:

• preparing a list of medicinal products for accession negotiations;
• excluding products subject to centralised authorisation by the European Medicines Agency (EMA);
• defining the transition period;
• setting deadlines for MAHs to submit updated dossiers.

In Lithuania, the transition period lasted three years.

Dossier requirements

It was emphasised that marketing authorisation dossiers must follow the Common Technical Document (CTD) format and provide comprehensive evidence on quality, safety, and efficacy.

Common challenges identified during the transition included outdated clinical data, insufficient evidence supporting certain indications, and difficulties with fixed-dose combination products.

Where products did not meet the definition of a medicinal product, reclassification was considered as a possible solution, for example, as food supplements, cosmetic products, or medical devices.

Pharmacovigilance and GMP

Particular attention was paid to pharmacovigilance obligations and Good Manufacturing Practice (GMP) requirements.

Marketing authorisation holders must ensure a functioning pharmacovigilance system, appoint a Qualified Person for Pharmacovigilance (QPPV) in the EU, and submit safety reports for authorised medicinal products.

Manufacturing sites must be inspected by competent authorities of the European Economic Area or countries covered by Mutual Recognition Agreements.

Questions and answers session

During the discussion, pharmaceutical industry representatives raised practical questions on dossier adaptation, reference medicinal products, and regulatory procedures.

It was noted that responsibility for compliance with regulatory requirements rests primarily with marketing authorisation holders, while regulatory authorities provide oversight and guidance.

It was also emphasised that decisions on granting marketing authorisations in the EU are based solely on three criteria: quality, safety, and efficacy.

Next steps

Participants emphasized the importance of ongoing dialogue between regulators and the pharmaceutical sector as Ukraine moves toward alignment with EU pharmaceutical legislation.

The presentation and the meeting recording are available at the links.