Parliament Adopts Legislative Changes to Increase Traceability of Medicines in Stock

Matey Todorov

BTA Photo

Sofia,

14.02.2024 12:56

(BTA)

Parliament adopted on Wednesday at second reading amendments to the Medicinal Products in Human Medicine Act, which aim to increase the traceability of the quantities of medicinal products available on the territory of Bulgaria and to create an opportunity to curb the existing bad practices for unregulated parallel exports.

The amendments introduce an obligation for the National Council on Prices and Reimbursement of Medicinal Products to ensure the linkage of the national identification number of the medicinal product with the product code in the Positive Drug List, which will lead to improved traceability of medicinal products in the supply chain of medicines in Bulgaria.

For the purpose of payment of medicinal products with public funds, the Ministry of Health, the Bulgarian Drug Agency (BDA), the National Council on Prices and Reimbursement of Medicinal Products, the National Health Insurance Fund (NHIF), the Bulgarian Medicines Verification Organisation, wholesale and retail medicinal product authorisation holders, medical institutions, centres and hospices shall ensure interoperability and connectivity of their electronic systems for automated data exchange in the mass market. This is foreseen to happen within six months from the entry into force of these amendments.

Medicinal products for which the product code information has not been provided to the BDA within the specified period shall not be paid for with public funds for the duration of the default. For the purposes of payment of medicinal products with public funds, the BDA shall provide the NHIF and the Ministry of Health with this information on a weekly basis.

/RY/