Production of active ingredients

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

A producer of active ingredients must fulfil the following conditions:

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


A producer of active ingredients must be entered in the registry of producers of active ingredients, which is kept by the competent authority.


Conditions and evidence

Last updated: 18. 12. 2015