2024-02-15 04:07:54
The Parliament finally adopted in the second reading changes to the Law on Medicinal Products in Human Medicine, with the aim of increasing the traceability of the available quantities of medicinal products on the territory of Bulgaria and creating an opportunity to limit the existing bad practices for unregulated parallel export.
The amendments introduce an obligation for the National Council on Prices and Reimbursement of Medicinal Products to ensure the connection of the national identification number of the medicinal product with the product code in the Positive Drug List, which will improve the traceability of medicinal products in the drug supply chain in our country .
For the purposes of paying for medicinal products with public funds, the Ministry of Health, the Executive Agency for Medicines, the National Council for Pricing and Reimbursement of Medicinal Products, the National Health Insurance Fund (NHIF), the Bulgarian Medicines Verification Organization, the wholesale authorization holders and drug retail, medical facilities, centers and hospices ensure interoperability and connectivity of their electronic systems for automated real-time data exchange in machine-readable format. This is expected to happen within six months of the entry into force of the current amendments.
The holder of the authorization for use/certificate for the registration of a medicinal product is obliged to provide the Executive Agency for Medicines (EMA) with information on the product code within 14 days of the publication of the medicinal product in the Positive Medicinal List, respectively from the occurrence of a change in circumstances , BTA reported.
Medicinal products, for which information about the product code has not been provided to IAL within the specified period, are not paid with public funds for the period of non-fulfillment of obligations. For the purposes of paying for medicinal products with public funds, IAL provides weekly to the NHIF and the Ministry of Health this information about the medicinal products.
It is envisaged that medicinal products, the authenticity of which has not been verified through the safety indicators and the individual identification mark has not been deactivated in the system of registers in accordance with Delegated Regulation (EU) 2016/161, will not be paid for with public funds. This provision will apply six months after the amendments enter into force.
After the vote, Lachezar Ivanov (GERB-SDS) thanked everyone who participated in the adoption of this bill. Today, for the first time, I saw that we can be united for the cause of transparency in the distribution of medicines, he pointed out.