site.btaBan on Export of Certain Types of Insulins and Antibiotics Extended

The ban on the export of certain types of insulin, medications that lower blood sugar, Semaglutide in injectable form, as well as medicines from the group of Azithromycin and Amoxicillin/clavulanic acid in powder and granulate form, has been extended The ban is specified by order of the Minister of Health, published on the website of the Ministry of Health, and is in force from June 24 until August 25, 2025.

The restriction is necessary to ensure access to medicines for Bulgarian patients. According to data from the Executive Agency for Medicines and regional health inspectorates, there are difficulties in supplying pharmacies and patients with the insulin medications and its substitutes, the export of which is banned.

Data provided by the regional health inspectorates show that there have been irregularities in deliveries and refusals by wholesalers to supply medicinal products corresponding to the international non-proprietary name Azithromycin 100mg/5ml and the international non-proprietary name Amoxicillin/clavulanic acid. According to information from the Executive Agency for Medicines, the specific medicinal products in the aforementioned dosage forms are not available from the marketing authorization holders or wholesalers. For the other medicinal products in the group “Antibacterial medicinal products for systemic use,” there have been reports of shortages in individual pharmacies in some areas.

In the case of two of the medicinal products in the group in oral powder and granules form, a notification of permanent discontinuation of sales has been submitted.

The first ban on exports of insulin and antibiotics was imposed in November 2023.