Wholesale of active ingredients

An active ingredient is any substance or a mixture of substances intended for use in the production of medicinal products which in the production procedure becomes an active ingredient of a medicinal product whose purpose is pharmacological, immunological or metabolic effect in order to re-establish, improve or change physiological functions or to determine a diagnosis.

A business entity engaged in the wholesale of active ingredients and is entered in the registry of wholesalers of active ingredients is a wholesaler of active ingredients. A wholesaler of active ingredients performs its activity in accordance with the guidelines and principles of good distribution practice for active ingredients.

A wholesaler of active ingredients must meet the following conditions:

  • employ an adequate number of experts with adequate education, considering the scope and complexity of wholesaling active ingredients;
  • have adequate premises, devices and equipment for the storage and transport of active ingredients in accordance with the guidelines and principles of good distribution practice for active ingredients;
  • perform the activity in accordance with the guidelines and principles of good distribution practice for active ingredients.

Conditions and evidence

Last updated: 27. 09. 2016