On July 12, 2015, the amendment to the Pharmaceutical Law Act, commonly called the “anti-export act”, was entered into force to stop the export of reimbursable medicines and to ensure availability of deficit medicines on the Polish market. Under this amendment, on January 1, 2017, new regulations came into force imposing additional obligations related to the provision of information on the trade in medicinal products. According to them, entrepreneurs are obliged to report data on the trade in medicines to the Integrated System for the Monitoring of Trade in Medicinal Products (ZSMOPL), in the field of data indicated in art. 72a sec. 2 – wholesale warehouses and retail pharmacies, limited service pharmacies and hospital pharmacy departments and in the field of data from art. 72a sec. 2 pt. 1 letters a-e and pt. 2-4 – responsible entities.
What is ZSMOPL?
ZSMOPL is an ICT system that is designed to enable daily reporting of transactions, stock levels, and deficiencies in access to monitored products through electronic means of communication. The main task of the system is to support the public administration bodies, including the minister in charge of healthcare, the Chief ...