Bulgaria has completed a consultation on changes to the rules for unlicensed, off-label and compassionate-use medicines, alongside products supplied through the special Article 266a route. The consultation ran from 21 July to 20 August and combined changes to exceptional access with more formal purchasing and expenditure controls.
The Ministry of Health (Министерство на здравеопазването, MoH) proposed the changes through the Проект наНаредба за изменение и допълнение на Наредба № 10 от 2011 г. (Draft Ordinance amending Ordinance No. 10 of 2011). The proposal substantially expands an earlier draft consulted on in April.
Treatment protocols would become electronic documents signed electronically. The Bulgarian Drug Agency (Изпълнителна агенция по лекарствата, BDA) would receive more structured information on the medicine, supplier, treatment regimen, diagnosis and hospital. Healthcare institutions would also need formal procedures for receipt, storage and dispensing.
The proposal introduces clearer competition requirements for hospital purchasing. Invitations would normally be open to an unrestricted number of wholesalers, with at least three working days for bids. Selection would usually be based on the lowest price per unit of active substance, supported by documented market research and publication of contract awards. These changes follow recommendations from the Commission for Protection of Competition (Комисия за защита наконкуренцията, CPC).
A parallel change would require the National Health Insurance Fund (Национална здравноосигурителна каса, NHIF) to provide the MoH electronically with individual funding applications and proposed prices, supporting monthly forecasting of exceptional-access expenditure.
The MoH must now review consultation submissions and decide whether to revise the text before final adoption by the Health Minister. Any adopted amendments would then require publication in the State Gazette before taking effect. No target date for completion has been announced.
Source: Ministry of Health
Link: Проект на Наредба за изменение и допълнение на Наредба № 10 от 2011 г. (Draft Ordinance amending Ordinance No. 10 of 2011)
Date: 21 July 2026
Source: Ministry of Health
Link: Мотиви към проекта на Наредба за изменение и допълнение на Наредба № 10 от 2011 г. (Explanatory memorandum to the draft Ordinance amending Ordinance No. 10 of 2011)
Date: 21 July 2026
