Poland’s NSA overturned penalties, stating pharmaceutical inspectors can only impose sanctions during formal inspections, not via document requests.
NSA Overturns Penalties
Poland’s Supreme Administrative Court (NSA) annulled rulings by the Warsaw Administrative Court, the Chief Pharmaceutical Inspector (GIF), and a regional inspector. The court emphasized that pharmaceutical law provisions (Journal of Laws of 2025, item 750 with amendments) imposing financial penalties apply exclusively when an agency conducts a formal control or inspection. If such activities are not initiated, a demand for document submission cannot be considered valid, and its non-compliance cannot lead to sanctions.
Problematic Demand and Penalty from GIF
The case stemmed from a contentious document request issued by the GIF and a subsequent fine levied against an entrepreneur. The NSA clarified that without a formal inspection underway, the inspector’s demand lacked legal basis for enforcement, rendering the penalty unlawful.