Chief Pharmaceutical Inspectorate

During the meeting, the organisational framework of the Polish State Pharmaceutical Inspection was presented, including responsibilities related to the control of the manufacture and distribution of medicinal products, monitoring their availability, and overseeing medicine quality. Cooperation with other public institutions and the importance of efficient information exchange in regulatory decision-making processes were also discussed.

A significant part of the discussions concerned organisational models of pharmaceutical market supervision. Differences between the Polish system – based on the division of competences between the marketing authorisation authority and the inspection authority – and solutions adopted in other European countries were analysed.

Particular attention was also paid to the practical challenges faced by regulatory authorities, such as ensuring system continuity and the effectiveness of inspections in emergency situations. In this context, opportunities for cooperation in conducting inspections of medicinal product manufacturing facilities located in Ukraine were discussed, including the use of remote tools and potential activities requiring additional interinstitutional arrangements.

The meeting also addressed regulatory issues concerning selected segments of the pharmaceutical market, particularly controlled substances. The exchange of experience in this area constitutes an important element in building effective and proportionate supervisory mechanisms.

The meeting confirmed the importance of direct dialogue and expert-level cooperation between institutions. The parties declared their readiness to continue joint activities, including organising training initiatives and strengthening working-level contacts.

On behalf of the State Expertise Center of the Ministry of Health of Ukraine, the meeting was attended by: Edem Adamanov, Director; Mykhailo Pasichnyk, Deputy Director; Olga Sadovnycha, Head of the Department of International Cooperation, European Integration, and Quality Assurance; and Valeriia Serikova, Head of the Communications and Public Relations Department.

The Chief Pharmaceutical Inspectorate was represented by: Łukasz Pietrzak, Chief Pharmaceutical Inspector; Magdalena Rychter, Director of the Pharmaceutical Supervision Department; Irena Rutkiewicz, Deputy Director of the Pharmaceutical Supervision Department; Marcin Rynkiewicz, Director of the Inspection Department; Olga Sierpniowska, Director of the Office of the Chief Pharmaceutical Inspector and Spokesperson; along with other staff members.