Harmonisation of Blood Safety Standards with the EU

On 19–20 January 2026, an onsite two-day meeting was held at the premises of the State Service of Ukraine on Medicines and Drugs Control (Ukraine) within the framework of the EU–UA Twinning Project “Support the establishment of the state control authority for medicines and medical devices”. The meetings were dedicated to Activity 3.11 – Blood Safety Training and Regulatory Exchange.

The meetings brought together the EU expert Daumantas Gutauskas, Director of the National Blood Center of Lithuania, and representatives of the State Service of Ukraine on Medicines and Drugs Control, including its management and specialists responsible for blood production, certification, inspection, and licensing.

Regulatory Framework and Good Practice Provisions

During the first day, discussions focused on the Lithuanian regulatory framework governing blood services, in particular the Good Practice Provisions for Blood Donation Institutions and Hospital Blood Banks. The Lithuanian side explained that these provisions are general in nature, based on EU Directives, and could be implemented in Ukraine within approximately six months, subject to the introduction of relevant legislative amendments.

Special attention was given to laboratory control and accreditation issues. It was clarified that ISO 15189 accreditation is voluntary in Lithuania, while national accreditation of healthcare institutions and laboratories is mandatory and carried out by the competent national authority.

Structure of Blood Services and Plasma Collection

Participants reviewed the structure of blood services in Lithuania, including the role of the National Blood Center, the operation of fixed and mobile blood collection sites, and licensing approaches for hospital blood banks. It was confirmed that plasma fractionation facilities do not operate in Lithuania and that all plasma originates from whole blood donations and is placed on the EU market.

In comparison, the Ukrainian side outlined current challenges related to remunerated plasma donation, private plasma centers, and legal inconsistencies between different legislative acts governing blood activities and licensing.

Inspections, Licensing, and Transitional Solutions

The second day focused on inspection practices, unplanned inspections, detection of illegal activities, and licensing issues. The Lithuanian expert shared practical approaches to dealing with unlicensed activities, noting that entities operating without a license cannot legally function and are subject to immediate action by competent authorities.

Both sides agreed that a legal analysis of several Ukrainian legislative acts is required to address existing inconsistencies. The possibility of introducing transitional solutions, including a temporary transition period, was discussed as a way to ensure regulatory continuity.

Donor Testing, Eligibility, and European Guidance

Discussions also covered donor testing strategies, including serological and NAT testing, donor eligibility criteria, and the application of recommendations contained in the EDQM Blood Guide. It was noted that, although these documents are not legally binding in EU Member States, they are widely applied in practice and treated as quasi-mandatory guidance, making them particularly relevant for Ukraine’s EU alignment process.

Next Steps

As a result of the two-day onsite meetings, the parties agreed to:

• continue the exchange of regulatory and inspection-related documents, including translations;
• submit additional questions in writing for further discussion during online meetings.
• explore the possibility of organising future training activities and study visits to Lithuania, particularly in the field of blood establishment inspections.