The Council of Ministers has adopted a draft law amending the Pharmaceutical Law, which removes the obligation for pharmaceutical companies to submit information on the planned place of delivery of medicinal products to the Integrated System for Monitoring Trade in Medicinal Products (ZSMOPL). The amendment is aimed at simplifying procedures and reducing the administrative burden.
Changes to the Pharmaceutical Law: simplifying monitoring of drug supplies
Published May 13, 2025 19:11
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The amendment to the Pharmaceutical Law, prepared by the Health Minister, is part of the government's deregulation efforts. The main purpose of the amendments is to abolish the obligation for pharmaceutical companies to report to the Integrated System for Monitoring Trade in Medicinal Products (ZSMOPL) the planned place of delivery of drugs intended for sale in Poland.
Currently, this obligation poses a significant challenge for pharmaceutical companies, since at the reporting stage it is often impossible to clearly determine which wholesaler a particular shipment will go to. This is because it happens that the decision about the destination is made only at a later stage of the logistics process.
The Health Ministry argues that providing this information is unnecessary from the point of view of monitoring the availability of medicinal products. This is because data on actual delivery locations is obtained directly from pharmaceutical wholesalers on the basis of daily reporting under ZSMOPL. Therefore, the obligation to indicate the planned place of delivery duplicates the information already collected.
After the change in regulations, pharmaceutical companies will not have to report planned delivery locations, which should translate into a reduced administrative burden and a simplified logistics process.
The new regulations will take effect 14 days after they are published in the Official Gazette.
