The period for the ban on the export of insulins, their analogues and some antibiotics is extended until September 24, 2025. This is stated in an order of the Minister of Health Silvi Kirilov, published on the website of the Ministry of Health.
The insulins and their analogues are listed by their trade names in the order. The ban on the export of antibiotics applies to products from the group with the international non-proprietary name Azithromycin, Amoxicillin /clavulanic acid and Cefuroxime in dosage forms powder for oral suspension and granules for oral suspension.
Information has been provided by the Bulgarian Drug Executive Agency on the available quantities of medicinal products from the pharmacological groups subject to the export ban to wholesalers and holders of marketing authorizations, as well as by the regional health inspectorates on the conduct of inspections in “open-type“ pharmacies on the availability of medicinal products, covering large and smaller settlements.
Information was requested from the holders of marketing authorizations on the currently available quantities of medicinal products, as well as information on quantities delivered since the beginning of the year for medicinal products from the same groups, and planned deliveries for the next six months.
In summary, it was found that there is difficulty in supplying pharmacies and patients with certain insulins and analogues due to irregular delivery or delivery of smaller quantities. For two of the antibacterial medicinal products from the group in the dosage forms powder for oral suspension and granules for oral suspension, a notification for permanent suspension of sales has been submitted, and another has a suspended marketing authorization.
The purpose of the export ban is to ensure that the Bulgarian medicinal market is provided with sufficient medicinal products to meet the needs of the population.