site.btaParliament Approves at First Reading Legal Changes to Increase Traceability of Available Medical Drugs

On Wednesday, Parliament adopted unanimously at first reading, with 177 votes in favour, changes to the Medicinal Products in Human Medicine Act, introduced by Lachezar Ivanov and a group of people's representatives from GERB-UDF. The amendments aim to increase the traceability of the available quantities of medicinal products on the territory of Bulgaria and create an opportunity to limit the existing bad practices for unregulated parallel export.

With the changes, the National Council for Prices and Reimbursement of Medicinal Products is obligated to ensure the connection of the national identification number of a medicinal product with the product code in the Positive Drug List, which will lead to an improvement in the traceability of medicinal products in the drug supply chain in the country. The interoperability and information connectivity through the exchange of data in a machine-readable format of the specialized electronic system for the tracking and analysis of medicinal products, the register of national numbers for the identification of medicinal products, the information system of the National Health Insurance Fund and of the system of registers in the sense of Delegated Regulation (EU) 2016/161. The idea is for all systems to communicate with each other, Lachezar Ivanov explained.

MPs rejected with 57 votes in favour, 32 votes against and 42 abstentions amendments to the Medicinal Products in Human Medicine Act introduced by Kostadin Kostadinov and a group of MPs from Vazrazhdane. Petar Petrov from Vazrazhdane noted that the bill aims to ensure better access to medicines for the population. Petrov pointed out that the goal was to have 24-hour pharmacies in more municipalities, and to provide vending machines for medicines in small municipalities.