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How to know if a product is a medicinal product or not?

The State Agency of Medicines decides whether a product is a medicinal product or not. The classification of products takes place on a case by case basis. We take into account of all the characteristics of the product, in particular its composition, pharmacological properties, the manner in which it is used, the extent of its distribution, its familiarity to consumers and the risks which its use may entail.

The classification procedure is based on the Regulation of the Minister of Social Affairs, number 59 from 13.04.2005 The Conditions and Procedure for Classifying a Substance or Product as a Medicinal Product. 

In case of doubt on product`s classification we recommend to submit an application for classification to the State Agency of Medicines.

For the classification we need following data:

  • the name of the product;
  • the name of the manufacturer of the product;
  • data on the composition and characteristics of the product;
  • the package leaflet accompanying the product.

The information should be sent to [email protected].

The application shall be reviewed within 30 days and it is free of charge.

Last updated: 30.06.2022