Amendments to Ordinance No. 10 from 2011

The Ministry of Health published an update to Ordinance No. 10 from 2011, regulating the use of unauthorised medicinal products in Bulgaria. This ordinance covers various aspects of compassionate use and off-label applications of medicinal products. The main changes focus on the implementation of electronic documents, updating medicinal product lists, and establishing new criteria for selecting wholesalers.

What changes

The changes in Ordinance No. 10 from 2011 focus on modernization and improved organization. A key change is the requirement for protocols to be in electronic format with a qualified electronic signature, in accordance with European electronic transaction standards. Other modifications include updating medicinal product lists and introducing new procedures and criteria for selecting wholesalers, considering patients' health conditions and logistical aspects of deliveries.

Who is affected

The changes will primarily impact healthcare institutions and wholesalers of medicinal products. Healthcare facilities will need to adapt their procedures to comply with the new requirements for electronic documents and qualified electronic signatures. Wholesalers must submit bids that not only meet price demands but also cover additional logistical and organizational efficiency criteria.

Dates and deadlines

While the ordinance was published on October 23, 2026, a specific effective date remains unspecified, allowing preparation time for affected parties. Important provisions, such as § 10, become effective two months after publication, specifically on December 23, 2026.

Practical next steps

Healthcare institutions should incorporate the new requirements and integrate electronic document management systems if they haven't already. They should also update their standard operating procedures in line with the new regulations on the supply and use of medicinal products. Wholesalers should be ready to submit bids reflecting new criteria and stay informed about updates to product lists.

What to check for your situation

These changes primarily focus on administrative updates and technological requirements. No new specific obligations are introduced for all businesses, only for those involved in the health sector and the distribution of medicinal products.