2018/0227/BG
EC/EFTA
BG Bulgaria
  • 11 - Health care technology
2018-07-29
2018-05-29

Medicinal products

Act amending and supplementing the Medicinal Products in Human Medicine Act

The draft regulates measures for temporary restriction of the export of medicinal products that are paid by public funds and of which there is a shortage in the Republic of Bulgaria. A proposal is made for the creation of a specialised electronic system by the Bulgarian Drug Agency (BDA), through which real-time analysis to identify possible shortages in medicinal products will be carried out on the basis of information provided by the participants involved in the supply of medicinal products. There will be a temporary suspension on the export of medicinal products whose available quantities in the country are estimated to be less than 65 % of those needed to meet the health needs of the population for a 1-month period, based on the average monthly consumption of the respective medicinal product over the previous 6 months. On the basis of the analysis generated by the electronic system, the BDA will prepare a list of the medicinal products that are included in the Positive Drug List and of which there is a shortage in the Republic of Bulgaria. The list will be updated on a weekly basis or if circumstances change, and will be published on the BDA’s website. The medicinal products will not be available for export for as long as they remain on the list.