Study visit hosted by the Bulgarian Drug Agency (BDA)

The Bulgarian Drug Agency (BDA) organised a study visit on 8–9 September 2026 in its premises in Sofia to exchange experiences and discuss activities and ongoing initiatives related to medicines availability and market supervision.

The study visit was opened by BDA Executive Director Bogdan Kirilov, who welcomed the participants and highlighted the importance of European cooperation and the exchange of good practices in addressing challenges related to medicines availability. The meeting also benefited from the active participation of Rasdolav Ruitchev, Chief Inspector, and Emilia Stoyanova, Chief Expert.

The two-day programme began with an overview of the BDA’s competences and activities, followed by a presentation of the Bulgarian pharmaceutical market and the mechanisms in place to monitor market developments and prevent and mitigate medicine shortages.

Particular attention was given to the roles and responsibilities of the different stakeholders involved in medicines availability, as well as to cooperation and information-sharing between competent authorities and market stakeholders.

The programme also covered the role of the SPOC Working Party in the exchange of information on critical shortages and other measures to safeguard medicines availability, including import exemptions, market supervision inspections and communication with marketing authorisation holders.

Participants also exchanged experiences on the use of National Medicine Verification System (NMVS) data for reimbursement purposes and discussed the opportunities and challenges associated with the use of such data.

The study visit brought together 12 participants from European national competent authorities, including representatives from Czechia, the Netherlands, Belgium, Ireland, Finland and Portugal.

The visit provided an important opportunity to strengthen cooperation between European competent authorities, share practical experiences and identify common approaches to improving medicines availability and market supervision across Europe.