site.btaGovernment Approves Amendments to Medicinal Products in Human Medicine Act

The Council of Ministers approved amendments to Medicinal Products in Human Medicine Act.

The proposed amendments concern the wholesale and retail trade of medicinal products, parallel import of medicinal products, improvement of the Specialized Electronic Tracking and Analysis System of Medicinal Products (SETAS), as well as administrative and penal provisions.

The bill proposes measures to address cases of shortages or unavailability of medicinal products by streamlining the obligations of all actors in the supply chain of medicines, by changes to the calculation algorithm set out in the SETAS, and by changes to the penalty provisions.

The changes will ensure the security of the medicines supply process, limit the cases of lack or shortage of essential medicines for the population, and ensure maximum transparency and traceability in the medicines supply system.